Category Archives: California Stem Cells

Stem cell characterization kitst Market sizeis done based on a triangulation methodology that is primarily based on experimental modelling approaches such as patient-level data or disease epidemiology for any key indications , number of procedures and install base analysis for any equipment to obtain precise market estimations for the base year as well as in historic data analysis.

Bottom-up approach is always used to obtain Stem cell characterization kits insightful data for the specific country/regions. The country specific data is again analyzed to derive data at a global level.

Market Overview:-

Stem cells are biological cells that can be converted into specific type of cells as per the bodys requirement. Stem cells are of two types, i.e., adult stem cells and embryonic stem cells. Stem cells can be used to treat various diseases such as cancer, neurodegenerative disorder, cardiovascular disorder and tissue regeneration. Stem cell characterization is the initial step for stem cell research.

Stem cell characterization kit is required to understand the utility of the stem cells in downstream experiments and to confirm the pluripotency of the stem cell.The growth of the stem cell characterization kits market is expected to be being fuelled by government funding for stem cell research.

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Fact.MR, a leading authority on market research brings original, in-depth, and insightful reports to investors On Stem Cell Characterization Kits Market Sales & Demand. Fact.MRs report will highlight various growth forecasts, key trends, and notable segments ripe for upcoming investments.

Key Parameters analyzed while estimating the Stem Cell Characterization Kits market include:

Overall Population by age group/Prevalence or Incidence of any disease/Treatment Seeking Rate/Dosage pattern/Average duration of treatment/Overall treatment cost and Reimbursement are considered.

Overall Population/Prevalence or Incidence of disease/treatment seeking rate/ average duration of the treatment/average number of devices used per patient / average number of procedure per device/ average selling price per device/reimbursement are considered.

Number of Healthcare facilities (Hospitals/Ambulatory Surgical Centers/Clinics etc.)

Average number of devices installed per facilities/ lifespan of the devices/replacement rate of the equipment/new sales of the equipment per year/average selling price per equipment are considered.

Extensive rounds of primary and a comprehensive secondary research have been leveraged by the analysts to arrive at various estimations and projections for Sales & Demand of Stem Cell Characterization Kits, its market share, production footprint, current launches, agreements, ongoing R&D projects, and market strategies.

SWOT analysis has been performed in the Sales study to investigate the strengths, weaknesses, opportunities and threats of each player, both at global and regional levels

Company share analysis is used to derive the size of the global Stem Cell Characterization Kits market. As well as a study of the revenues of companies for the last several years also provides the base for forecasting the market size and its Sales growth rate.

This study offers an overview of the existing market trends, metrics, drivers, and restrictions and also offers a point of view for important segments. The report also tracks product and services demand growth forecasts for the market.

Stem Cell Characterization Kits Market Segmentation:

Based on type of stem cell, the stem cell characterization kits market is segmented into:

Based on application, the stem cell characterization kits market is segmented into:

Based on end user, the stem cell characterization kits market is segmented into:

North America and Europe are expected to witness significant growth in the global stem cell characterization kit market over the forecast period. This is owing to presence of key manufacturers and researchers of stem cell based therapies in these regions. Moreover, manufacturers such as ThermoFisher Scientific, and Becton Dickinson providing stem cell assays are present in North America region.

Asia Pacific is expected to show significant growth in the stem cell characterization kit market over the forecast period, as researchers from China and Japan are working on stem cell based therapies. For instance, in 2017, clinical trials of embryonic stem cells were launched in China for Parkinsons disease.

The Stem Cell Characterization Kits Sales study analyzes crucial trends that are currently determining the growth of Stem Cell Characterization Kits Market.

There is also to the study approach a detailed segmental review. The report mentions growth parameters in the regional markets along with major players dominating the regional growth.

The Key trends Analysis of Stem Cell Characterization Kits also provides dynamics that are responsible for influencing thefuture Sales and Demand of Stem Cell Characterization Kits marketover the forecast period.

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The report covers following Stem Cell Characterization Kits Market insights and assessment that are helpful for all participants involved in the Stem Cell Characterization Kits market:

NOTE:Our team are studying Covid19 and its impact on the Sales growth of Stem Cell Characterization Kits market and where necessary we will consider the Covid-19 footmark for better analysis of the market Demand and industries outlook. Contact us cogently for more detailed information.

Further, the Stem Cell Characterization Kits market Survey report emphasizes the adoption pattern And Demand of Stem Cell Characterization Kits Market across various industries.

The Stem Cell Characterization Kits Sales study offers a comprehensive analysis on diverse features including production capacities, Stem Cell Characterization Kits demand, product developments, Stem Cell Characterization Kits revenue generation and Stem Cell Characterization Kits Market Outlook across the globe.

Competitive Landscape Analysis On Stem Cell Characterization KitsMarket:

In this report, leading market participants involved in the manufacturing of Stem Cell Characterization Kits are covered. Analysis regarding their product portfolio, key financials such as market shares and sales, SWOT analysis and key strategies are included in this report. To provide decision-makers with credible insights on their competitive landscape, the Stem Cell Characterization Kits industry research report includes detailed market competitive landscape analysis.

Some of the key participants in the global Stem Cell Characterization Kits Market include :

Examples of some of the key participants in the stem cell characterization kits market identified across the value chain include Merck KGaA, Celprogen, Inc., Creative Bioarray, Thermo Fisher Scientific Inc., BD Biosciences, R&D Systems, Inc., System Biosciences, Cosmo Bio USA, BioCat GmbH, and DS Pharma Biomedical Co., Ltd.

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After glancing through the report on globalStem Cell Characterization Kits market Demand, readers will get valuable insight into the following:

The Survey report highlights the growth factors and entry barriers for the key players and talks about the new trends emerging in the globalStem Cell Characterization Kitsmarket.

In addition to this, the study sheds light on changing market size, revenue growth, and share of important product segments. Analysts at Fact.MR give prominent data on recent technological developments and product developments in the Stem Cell Characterization Kits Demand during the assessment period.

A comprehensive estimate on Demand of Stem Cell Characterization Kits market has been provided through an optimistic scenario as well as a conservative scenario, taking into account the sales of Stem Cell Characterization Kits market during the forecast period. Price point comparison by region with global average price is also considered in the study.

Market Snapshot

The rising prevalence of cancer, cardiovascular disorders and neurodegenerative diseases and the role of stem cell therapy in treating these diseases is projected to drive the growth of stem cell characterization kit market.

As per the American Cancer Society, in 2017 cancer accounted around 1 out of 4 deaths in the U.S. and was the second most common cause of deaths in the U.S.

Stem cell therapy and stem cell transplant has huge potential to treat such chronic diseases, which is expected to have a positive impact on the growth of the stem cell characterization kits market.

Stem cell transplant is useful for the treatment of spinal cord injury, stroke, and Alzheimers disease, which is expected to fuel the adoption of stem cell characterization kits over the forecast period.

The Stem Cell Agency, California, is working on the development of new stem cell-based therapies for chronic diseases such as cancer and rare diseases, where stem cell characterization kits are primarily required.

Stem cell characterization kit is also required to identify the appropriate stem cells for the treatment of -Thalassemia. Due to the increasing research and study on stem cells, the stem cell characterization kit market is expected to witness significant growth over the forecast period.

The role of stem cell characterization kit is very important because if the stem cells are not characterized properly into required adult cell type, transplanted stem cells may revert back to teratomas and there is a possibility of transplant rejection. This is expected to influence the growth of the stem cell characterization kit market.

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Chronic Diseases Is Expected To Have Positive Impact On Stem Cell Characterization Kits Market Demand Bloomingprairieonline - Bloomingprairieonline

Cleveland Cell Therapy Incubator selected as production hub for Deverra's cord-blood derived therapeutics

CLEVELAND and SEATTLE, April 5, 2022 /PRNewswire/ -- Deverra Therapeutics, Inc., a leading clinical-stage company in Seattle, Washington, developing therapeutic allogeneic off-the-shelf cord blood-derived cell products, has entered into a manufacturing service agreement with the Cleveland Cell Therapy Incubator (CCTI), a subsidiary of the Cleveland Cord Blood Center (CCBC).

Cleveland Cord Blood Center logo

Since 2018, CCTI and Deverra have successfully collaborated on supply programs utilizing frozen cord blood products. To support Deverra's next mid-stage clinical development programs, Deverra Therapeutics has selected CCTI for the manufacturing of the required clinical grade materials.

CCTI will be the production hub for clinical-grade expanded cord blood progenitors and immune cells using Deverra's proprietary manufacturing platforms to support Deverra's FDA-approved clinical studies.

With the agreement, the collaborations will extend to using these supplies for manufacture of Deverra products at CCTI's Cleveland, Ohio facility, providing Deverra with the flexibility for product sourcing to expand manufacturing. For CCTI, this is an important opportunity to establish itself in the rapidly growing field of cell therapy manufacturing for novel treatments of cancer and other life-threatening diseases.

"Our organizations are well-acquainted and have already developed a track record of collaborative success and flexibility. We look forward to supporting Deverra's product lines as they move towards approved clinical therapies," said Wouter Van't Hof, Director, Cord Blood Bank and CEO, Cleveland Cell Therapy Incubator.

"This is an exciting step forward in our partnership with CCTI, leveraging our respective expertise from cell sourcing to manufacturing and clinical development of innovative cell therapies. We are excited to work together to accelerate these therapies through this partnership and make a difference in the lives of patients with life-threatening disorders," said Colleen Delaney, CSO and EVP of Research and Development, Deverra Therapeutics.

Story continues

About the Cleveland Cord Blood Center (CCBC) The Cleveland Cord Blood Center (CCBC), is a not-for-profit 501(c)(3), independent public cord blood bank serving as a leader in the collection, processing, storage and distribution of quality cord blood stem cell units for transplantation in patients with life threatening disorders such as leukemia, lymphoma and immune system disorders. The Center is one of only eight FDA-approved Cord Blood Centers in the U.S. Launched in 2008, The Cleveland Cord Blood Center was founded in 2008 by Mary J. Laughlin, M.D., who performed one of the world's first successful umbilical cord blood stem cell transplants on an adult leukemia patient in 1995. With headquarters in Warrensville Heights, Ohio, umbilical cord collection sites are located in Cleveland, Ohio, Atlanta, Georgia, and San Francisco and San Leandro, California. For more information, visit clevelandcordblood.org or call 1-866-922-3668.

About Deverra Therapeutics, Inc.Deverra is a leading developer of allogeneic off-the-shelf cell therapies for patients with cancer and other critical diseases. Deverra's proprietary Notch ligand technology platform serves as the foundation for its ongoing clinical, preclinical and discovery programs. The company currently has three active INDs, with two phase 1 trials utilizing an unmodified NK cell therapy in COVID-19 and in AML/MDS.

Deverra's lead product candidate dilanubicel, an ex vivo expanded allogeneic off-the-shelf hematopoietic stem/progenitor cell therapy, has been evaluated in a phase 2 randomized controlled trial for adult patients with de novo AML as an adjuvant to standard of care induction/consolidation chemotherapy. Treatment with dilanubicel was associated with improved treatment outcomes and statistically significant increased incidence of complete remission. Deverra is also pursuing multiple preclinical and discovery programs in the development of engineered NK and myeloid cell therapies. For more information, visit Deverratx.com.

Cision

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SOURCE Cleveland Cord Blood Center

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Cleveland Cord Blood Center and Deverra Therapeutics Announce Agreement - Yahoo Finance

image:Scientists reprogrammed skin cells from patients with epilepsy to differentiate into cortical organoids with hallmarks of the malformation known as focal cortical dysplasia view more

Credit: Simoni Avansini

Focal cortical dysplasia is a malformation of the cerebral cortex associated with one of the most severe types of epilepsy. Treatment is difficult owing to a lack of effective drugs or access to surgery. A new human model developed by researchers at the University of Campinas (UNICAMP) in the state of So Paulo, Brazil, using organoids cultured from patients cells has now opened up opportunities to test more specific therapies and medications.

In partnership with a group at the University of California San Diego (UCSD) in the United States, the researchers for the first time created cortical organoids that mimic focal cortical dysplasia and identified mechanisms that may be involved in the emergence of the anomaly during brain formation. They also obtained electrical readouts resembling the neuronal discharge typical of epileptic seizures in humans.

The results arereportedin a paper inBrain, a leading clinical neurology and translational neuroscience journal. They can be the basis for future research to test drugs for patients with severe epilepsy, who continue to have frequent seizures after surgery or after taking prescription drugs for two years.

The organoids were cultured in vitro to simulate the morphology and functioning of part of the brain from skin cells donated by four patients with severe epilepsy treated at UNICAMPs teaching hospital (Hospital de Clnicas). The cells were reprogrammed to become pluripotent stem cells and differentiate into neural cells.

Morphological, molecular and functional analysis of the organoids pointed to characteristics of this cortical malformation such as impaired cell proliferation, neuronal network hyperexcitability, dysmorphic neurons, and the presence of balloon cells, so called because of their shape, with a neuron-like nucleus and cytoplasm similar to an astrocytes.

We observed molecular alterations compatible with what was expected in cellular pathways associated with neuron development and maturation. We also showed that its possible to create a cortical organoid with electrical activity resembling the neuronal discharges seen in epilepsy. In sum, our model mimics what we see in patients and can be used in future to screen existing medications,Iscia Lopes-Cendes, a professor at UNICAMPs Medical School and penultimate author of the paper, toldAgncia FAPESP.

The study was conducted during thedoctoral researchofSimoni Avansiniunder the aegis of the Brazilian Research Institute of Neuroscience and Neurotechnology (BRAINN), a Research, Innovation and Dissemination Center (RIDC) funded by FAPESP. The study also received funding from FAPESP via three other projects (17/50404-1,19/09090-9and18/02967-0).

Animal models are of limited usefulness in studies of this type of epilepsy because the cerebral cortex in rodents, for example, is very different from the human cortex and does not have similar malformations. In the area of epilepsy, this is a very important study. Various attempts have been made, with successes and failures, over a period of many years. The result is a major reward for Simonis perseverance, a key quality in research, said Lopes-Cendes, BRAINNs principal investigator.

Epilepsy is an incurable neurological disease affecting some 50 million people worldwide, according to the World Health Organization (WHO). About 2 million cases have been reported in Brazil.

Patients with severe epilepsy may have 40-50 seizures per day, losing consciousness and collapsing. Treatment involves a combination of drugs, which do not always work. Most medications inhibit the activity of neurons in a generalized manner, controlling seizures but with many side effects, such as drowsiness and memory problems. Surgical removal of part of the brain is indicated in about 40% of patients with refractory seizure disorders after taking medication for a year.

Uncontrolled seizures not only have a highly adverse effect on the patients quality of life but constitute a major risk of premature sudden death, which can be as much as three times the average for the overall population. In addition, about half of all adults with epilepsy have other disorders such as depression and anxiety (more at:www.who.int/publications/i/item/epilepsy-a-public-health-imperative).

We succeeded in mimicking the development of the neocortex and some hallmarks of focal cortical dysplasia, Avansini said. The advantage of our method was that we used a human model that maintained the patients genetic background. With an organoid, its possible to study each stage of the malformation, which starts with development of the cortex, with repercussions for cell proliferation and differentiation.

The literature is not clear as to how abnormal cortical development contributes to the creation of epileptic seizures in dysplastic cortical tissue. Earlier research by the group, resulting from Avansinis doctorate and reported in a 2018 article, suggested that dysregulation of the expression of the geneNEUROG2, important to the differentiation of neurons and glial cells (astrocytes, oligodendrocytes and microglia), plays a key role in development of the disease (more at:agencia.fapesp.br/27809).

Sample

The researchers used skin cells from four patients who had not responded to treatment with medication or surgery. One had undergone three surgical procedures, which resulted in less frequent seizures but did not achieve the expected result. The other three had had two operations and included a child who started having convulsions at 14 months and whose speech had been partly impaired.

Our data points to a molecular disruption in neuroepithelial junction cells affecting how some neurons form the cortical plate, leading to neural network alterations that make these patients susceptible to epilepsy,Alysson Muotri, a professor at UCSD and last author of theBrainpaper, says in avideoabout the study.

To capture the electrical data, the scientists used two techniques, one of which was an innovation in this field of research and involved inserting specially designed electrodes into the organoid. They succeeded in working with three-to-five-month-old organoids, which are hard to grow because most organoids die quickly for lack of a vascular system.

Were motivated by challenges, Avansini said. A relative of mine had epilepsy and died as a result of a seizure. When you experience something like that, you know exactly how families of patients feel. Thats what makes me tick. Our group has achieved progress in several ways but much remains to be done, and the search continues.

Next steps, she explained, include trying to understand more about how epilepsy develops, focusing on the proliferative region to investigate how the cells and circuit are formed, and verifying whether interventions are feasible in the system as part of novel therapies.

Avansini is currently a researcher in the Bioimaging Division of the Brazilian Bioscience National Laboratory (LNBio), a research institution that uses synchrotron light and is part of the Brazilian Center for Research in Energy and Materials (CNPEM), alongside three other laboratories: Sirius, the National Synchrotron Light Laboratory (LNLS); the National Biorenewables Laboratory (LNBr); and the National Nanotechnology Laboratory (LNNano).

Our RIDC is achieving its remit of producing good science and training independent researchers who will continue to do good science, Lopes-Cendes said.

###

About So Paulo Research Foundation (FAPESP)

The So Paulo Research Foundation (FAPESP) is a public institution with the mission of supporting scientific research in all fields of knowledge by awarding scholarships, fellowships and grants to investigators linked with higher education and research institutions in the State of So Paulo, Brazil. FAPESP is aware that the very best research can only be done by working with the best researchers internationally. Therefore, it has established partnerships with funding agencies, higher education, private companies, and research organizations in other countries known for the quality of their research and has been encouraging scientists funded by its grants to further develop their international collaboration. You can learn more about FAPESP atwww.fapesp.br/enand visit FAPESP news agency atwww.agencia.fapesp.br/ento keep updated with the latest scientific breakthroughs FAPESP helps achieve through its many programs, awards and research centers. You may also subscribe to FAPESP news agency athttp://agencia.fapesp.br/subscribe.

Cells

Junctional instability in neuroepithelium and network hyperexcitability in a focal cortical dysplasia human model

27-Dec-2021

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A model that mimics malformation associated with severe epilepsy paves way to novel therapies - EurekAlert

One year ago this month, a $5.5 billion wave washed over Californias ambitious stem cell agency and left it refreshed and renewed for another decade or so of searching for miraculous treatments for a host of deadly, incurable afflictions.

Officially known as the California Institute for Regenerative Medicine (CIRM), the agency has seized its new role with alacrity at least when it comes to awards. It is now on a pace to hand out $38,000 an hour, 24 hours a day, seven days a week. That would amount to $519 million in awards between this time last year and the end of the agencys current fiscal year in June.

We really have a bright future ahead of us leveraging our successes. Maria Millan

Its a new era for CIRM, said the president and CEO of CIRM, Maria T. Millan, on Tuesday. She declared that the agencys new, just-approved strategic plan will deliver the full potential of regenerative medicine and lead to transformative stem cell therapies.

That is a far cry from the fall of 2020 when CIRM was literally planning to close its doors if voters rejected Proposition 14, the ballot initiative that refinanced the agency. Failure of the measure would have terminated the largest state-financed stem cell research effort in the nation. And it would have ended what is a historical first, the creation of a major, state-run stem cell research program in the Golden State.

Proposition 14 provided more than $5.5 billion. The 17,000-word measure also launched the agency on a broader, new course of financing cutting-edge science plus assigning it the formidable tasks of attempting to ensure the affordability of $2 million therapies and funding an $80 million community care centers building program.

We really have a bright future ahead of us leveraging our successes, said Millan 12 months ago, just after the vote on Proposition 14 was certified. Since then, she has been crafting a five-year strategic path to secure that future.

Not discussed in CIRMs plan, however, is the fact that the agency is yet to fulfill 2004 voter expectations.

Approved this week by the 35-member CIRM board, the plan includes the new affordability effort and the community care centers. It also promises new data-sharing and collaboration programs to strengthen the entire field. It contains a strong and increasing emphasis on diversity. It aims to create knowledge networks and technology competency hubs and build a skilled and diverse workforce. It vows to speed clinical trials to final federal approval of treatments and make them available for widespread use.

All of which would be embedded in financing research that promises one-and-done cures and transformative regenerative medicine. That expression includes such things as gene and stem cell therapies, along with tissue-engineered products to repair, replace, or regenerate organs, tissues, cells, genes and metabolic processes,

Not discussed in CIRMs plan, however, is the fact that the agency is yet to fulfill 2004 voter expectations that CIRM would produce what some have described as magical cures that would be widely available to the public for afflictions ranging from diabetes to cancer.

Asked whether California voters are impatient with CIRMs failure to back a generally available stem cell therapy, the agency replied this week in a statement, No. If they had been they would not have voted to approve Proposition 14.

CIRM plans to put the state of California at least part way into the business of manufacturing cell therapies via partnerships with industry.

The fact that they did approve it during a time of pandemic and economic uncertainty shows they understand that developing therapies takes time, and it also showed that they appreciated all we have achieved in the last 17 years, CIRM said in an email. (The full text is available on the California Stem Cell Report.)

Manufacturing Cures and SilosThe strategic plan is called Real Life. In it, CIRM acknowledges the obstacles that are hindering large scale production of therapies that would be available generally.

The field of regenerative medicine is advancing rapidly, driven by novel research tools and technologies that generate terabytes of data on human biology but has to date resulted in few demonstrably effective treatments for devastating diseases, CIRM says.

Several factors contribute to the limited scientific advancement in these areas, including:

1) Lack of attention and financial support (from non-profit and industry sectors) for high-risk/high reward research and therapy development, particularly in disease indications that are not commercially viable (i.e., rare diseases) or are complex (i.e., central nervous system-related diseases), and

2) The siloed nature of biomedical research and development.

To help overcome some of the manufacturing hurdles, CIRM plans to put the state of California at least part way into the business of manufacturing cell therapies via partnerships with industry. The Real Life plan says:

CIRM will establish a statewide manufacturing network comprising academic process development and GMP (good) manufacturing (practices) facilities as well as industry manufacturing partners to support the needs of a rapidly growing regenerative medicine industry in California, including workforce development.

CIRMs manufacturing aspirations are aimed at accelerating the commercialization of research that it has financed over the last 17 years.

The network will de-risk the development of transformative regenerative medicine therapies, CIRM says, advance the development and adoption of manufacturing technology platforms, promote adoption of quality standards such as quality-by-design, and educate, train, and employ a diverse California workforce.

CIRM has yet to allocate funds for specific segments of its strategic plan, but its manufacturing network could cost a bundle. However, CIRM is also likely to require co-matching funds from partnering businesses and not-for-profit institutions.

Ronnie Priyank

Bubble Babies and Intellectual PropertyCIRMs manufacturing aspirations are aimed at accelerating the commercialization of research that it has financed over the last 17 years. One example involves a three-year-old from the Sacramento, Ca., suburb of Folsom Ronnie Priyank.

When Ronnie was born, he seemed like a happy, healthy baby. But within a few days, a newborn screening test diagnosed him with X-linked SCID, a rare immune disorder that is often fatal within two years. Fortunately, doctors told his parents about a CIRM-funded clinical trial conducted by UC San Francisco and St. Jude Childrens Hospital, CIRM says in its strategic plan.

The case is a telling example of what policy experts call a wicked problem, one that is complex and intractable.

Ronnies genetic abnormality was corrected by doctors. A new blood supply repaired his immune system. He is now a happy, healthy three-year-old boy who loves going to school with other children, CIRM reports.

However, another case of a severe immune deficiency treatment has not ended so well. It created a difficult and unpleasant situation for CIRM this year, not to mention the families of 20 children.

The case is a telling example of what policy experts call a wicked problem, one that is complex and intractable. Its elements include the ultimate purpose of public funding of medical research, the search for profits, plus ethics and the lives of babies born without the ability to fight off even minor infections that could take their lives.

It is not a problem that is isolated to CIRM but encompasses much of the regenerative medicine business. And it could have major implications going forward for CIRM.

At the center of the situation is a rare genetic affliction often called the bubble baby disease, which is fatal if left untreated. First reported last May by Capitol Weekly and the California Stem Cell Report, it involves not only CIRM, but UCLA and the University of Californias system for licensing or selling research results, in this case, to a London firm called Orchard Therapeutics.

Over the years, CIRM has backed the cell and gene research by Donald Kohn of UCLA with $43 million. He has been working in the field for more than 30 years and has received funding from many other sources. UCLA says Kohns treatments, which are still in clinical trial, have saved the lives of 70 persons.

Some years ago, UCLA licensed exclusive rights to a Kohn treatment to Orchard. The rights do not belong to CIRM or Kohn but to the UC system. However, in 2020 Orchard quietly dropped the therapy in favor of potential treatments that it deemed would be more profitable.

Costs of cell and gene therapies could range upwards of $2 million, according to current estimates.

The families with the 20 children with the bubble baby disease were shocked and angry. They asked Orchard for compassionate use of the therapy, but the company turned them down.

This month, a subcommittee of the CIRM that deals with intellectual property moved to tackle the intellectual property process that helped to create the Orchard situation. The initial step gives the subcommittee a specific role in such disputes, but the committee indicated more is likely to be done this coming year.

A $2 Million Affordability ChallengeThe agencys new affordability and accessibility effort was slow to start this year. Proposition 14 called for appointments to the CIRM affordability panel to be made by early March. The 17 positions were not completely filled until October. The committee did not have its first meeting until last month. Nonetheless, the panel does have a sweeping scope and something in the neighborhood of $155 million from Proposition 14 to help come up with solutions.

The ballot measure charges the panel with satisfying Proposition 14s mandate that CIRM establish and oversee programs to help make its yet-to-be commercialized stem cell and gene therapies available and affordable for all Californians.

Costs of cell and gene therapies could range upwards of $2 million, according to current estimates. The affordability issue is far from new in the cell and gene therapy world. And the financial and ethical questions raised by affordability have already received a vast amount of attention internationally from industry and academics.

The chair of the affordability panel is former state legislator Art Torres, who also serves on the board of Covered California and the UC board of regents

Affordability is close to the heart of Robert Klein, the Palo Alto developer who sponsored both Proposition 14 of 2020 and Proposition 71 of 2004, which created CIRM. Klein was responsible for inserting the new affordability/accessibility language in Proposition 14. He told CIRMs affordability panel earlier this month:

Getting the cost of those therapies down to where they are possible economically for coverage by our California programsis a challenge that is critical for every family, but also for the state.

Unless we can get these therapies to be accessible and affordable, we cannot really deal with the burden of chronic illness over the next decade in California, much less the decades that follow.

The chair of the affordability panel is former state legislator Art Torres, who also serves on the board of Covered California and the UC board of regents. (Other members of the panel can be found here.)

Beefing up Diversity and EquityOver the past year, CIRM directors have focused sharply on diversity, equity and inclusion matters. In October, they inserted diversity and equity language into its mission statement, which now reads as a result: Accelerating world class science to deliver transformative regenerative medicine treatments in an equitable manner to a diverse California and world.

One change that Duron championed is a diversity, equity and inclusion score on all applications from scientists for some of CIRMs billions.

CIRMs new equity push began about two years ago. CIRM Director Ysabel Duron has given it regular, personal attention. She has insisted consistently this year that CIRM do more, particularly as it spends its $5.5 billion.

Duron wants the diversity/equity performance of awardees to be concretely measured and scored. One change that she championed is a diversity, equity and inclusion score on all applications from scientists for some of CIRMs billions.

Just this Tuesday at a CIRM board meeting, Duron said the strategic plan needed stronger and more specific language than an ambiguous word like diverse. Instead, CIRM should use language that would immediately tell people of color that CIRM was ready to serve them.

It is both our moral and ethical duty to recognize equity and inclusion, Duron told her fellow directors last fall. Specific language delivers a message, she said, It means me.It means my family. It means my community.

Royalties so far, however, have totaled only $557,292 as of last month.

CIRMs approach to the issue is likely to become more aggressive in 2022 as the agency refines and expands its approach.

CIRMs Death WarrantProposition 14 did more than provide a much-needed cash infusion, courtesy of Klein, who took personal charge of writing the measure. Proposition 14 also contained CIRMs death warrant. No more funding is provided after the $5.5 billion is gone, a fact that is almost never discussed at CIRM strategy sessions.

Proposition 14, however, did create something of a possible future revenue stream for the agency. It requires that royalties from CIRM-funded inventions go to assisting with affordability issues involving CIRM-backed therapies. Prior to approval of the ballot measure, those funds went into the general fund of the state, which is used for everything to paying state prison guards to running the state pesticides department.

A study financed by stem cell backers in 2004 estimated that royalties could run into the billions. Royalties so far, however, have totaled only $557,292 as of last month.

CIRM, which can receive gifts and raise money, could also align itself in the future with a non-profit entity that could serve as a possible vehicle to continue its existence if additional state funding is not available when the current $5 billion run out. Klein founded and is the head of such an organization, Americans for Cures.

CIRM could also stretch out its life by slowing the pace of its spending while it looks for a savior or awaits results that could stimulate voter approval of more billions. Another possibility is seeking funding from the legislature, but that could be a difficult task. Lawmakers might want to fiddle with the agencys independence. CIRM operates outside of the control of the legislature and the governor. Its funds flow directly to the agency without going through the normal state budget process.

The increase plus turnover in board members has left the board with a substantial number of members who are unfamiliar with CIRMs past activities

CIRM currently relies on state borrowing (bonds) to survive. It is limited to borrowing no more than $540 million a year. Its original funding in 2004 provided $3 billion. Proposition 14 added the $5.5 billion. With interest on the state bonds, the total cost of its work is estimated to be about $12 billion.

Another bond measure to refinance CIRM is problematic. Proposition 14 was narrowly approved by 51 percent of voters, well below the 59 percent in 2004. Without treatments that resonate with voters, another ballot measure could be in trouble, but an election is a very long way off. There is also the question of who might put up the many millions needed to qualify an initiative for the ballot and finance the campaign 10 years from now. Klein, 76, took that on in 2004 and 2020, providing millions himself and raising more.

New Faces and a New Chair for CIRMCIRM used to have 29 persons on its governing board, a size that some regarded as unwieldy and unnecessary. It was raised to 35 by Proposition 14, which is close to the number of seats in the state Senate (40). The increase plus turnover in board members has left the board with a substantial number of members who are unfamiliar with CIRMs past activities or the sometimes difficult process of operating in a very public arena.

CIRM staff has changed significantly in the last several years as the result of the wind-down prior to Proposition 14. The number of employees dropped from more than 60 to less than 30 during that time. But new hires have come aboard. CIRM expects to have 55 employees by the end of June and likely more in the coming years. The ramp-down, ramp-up roller coaster, nonetheless, has resulted in the loss of institutional memory and diverted energy away from the core of CIRMs work. Only two employees remain from CIRMs earliest years.

CIRM CEO Millan has been with the agency since 2012 and CEO since 2017. The chair of the governing board, Jonathan Thomas, and Vice Chair Art Torres will be termed out this year. The boards governance committee is expected to meet in January to discuss the replacement process, in which they only have an advisory role.

CIRM is now heavily engaged in supporting gene therapy, a burgeoning field that was on a scientific backburner in 2004

Statewide elected officials, such as the governor and state treasurer, nominate candidates to be voted on by the full board. The official qualifications for the chair are narrowly drawn so narrowly drawn, in fact, that in 2004 it was widely reported that only one person fit the legal bill Robert Klein, the man who sponsored and oversaw the drafting of the initiative that created CIRM.

Klein left the board in 2011, and Thomas succeeded him in a contested election on a 14-11 vote.

76 Clinical Trials, Gene Therapy, Conflicts of InterestWith the exception of failing to produce a widely available stem cell treatment, CIRM has chalked up an impressive record by virtually all assessments. It currently is helping to finance 76 clinical trials, an accomplishment that would not have been believed back in 2004. More than 3,200 patients are involved in those trials, Many others are enrolled in trials at CIRMs first-in-the nation Alpha Clinics.

CIRM is now heavily engaged in supporting gene therapy, a burgeoning field that was on a scientific backburner in 2004. CIRM is backing new-since-2004 research using reprogrammed adult stem cells. It has moved far beyond supporting controversial human embryonic stem cell research, which was the reason for its being in 2004, although that area remains part of CIRMs portfolio.

Conflict of interest issues have dogged the agency since its inception. The problems are built into CIRM by the ballot initiative

(In 2004, former President George Bush had restricted federal funding of human stem cell research, causing alarm and dismay in the scientific community. Some scientists even left the country to continue their work. In California, others supported the creation of the stem cell agency and campaigned vigorously for Proposition 71. Bushs restrictions were lifted in 2009, leading some to question whether CIRM was still needed.)

CIRM is not without its flaws. The most recent evaluation of it came in a state-required performance report released this fall. Paid for by CIRM itself, the $242,000 report recommended improvements in CIRM operations, including tracking royalties and in its information technology. Back in 2012, CIRM heard from the National Academy of Medicine in a $700,000 study, also paid for by CIRM. The prestigious body recommended far-reaching changes including reducing the size of the board and overhauling the grant award process. CIRM did not look kindly on the recommendations, including those dealing with conflicts of interest, perceived and otherwise.

Conflict of interest issues have dogged the agency since its inception. The problems are built into CIRM by the ballot initiative. Virtually all the parties who stood to benefit from CIRMs largess were given a seat at the table where the money is handed out (the governing board). Directors cannot vote on awards to their institution, but they vote on and participate in creation of awards programs and approving the rules for how the money is handed out. An analysis by the California Stem Cell Report and carried on Capitol Weekly showed that as of the summer of 2020, 80 percent of the $2.7 billion in awards at that time went to institutions that had links to past or current representatives on the board.

This fall the board repealed one of its own rules aimed at minimizing conflicts of interest. Eliminated were regulations that required board members to leave the room during meetings involving discussions on matters where they had a conflict of interest. Such a requirement is common, however, among local governments and a number of state agencies even they do not necessarily hand out billions of dollars.

The $8.5 billion that CIRM will have spent by the time the cash runs is a lot of money. It shrinks rapidly, however

(For more on the leave-the-room requirements in California, see here and here.)

Boiling the Ocean and MoreProposition 14s vast new vision for CIRM, however, may threaten to overwhelm the program. Indeed, that concern was expressed by some directors earlier this year when they warned about trying to boil the ocean. Many new avenues could be pursued under the terms of the ballot initiative, but even the ones dictated by Proposition 14 would challenge the grasp of any organization. Beyond the affordability effort, they include research involving mental health, therapy delivery, personalized medicine and aging as a pathology. That is not to mention a greater emphasis on supporting vital research opportunities that are not stem cell-related.

Proposition 14 also directs the agency to fund research training programs, but does not specify the amount that should be spent. CIRM has allocated $66 million this fiscal year for education and training. That necessarily means less money for research and product development. Few like to argue against training and education. But it is unlikely that voters, in approving the creation of CIRM in 2004, thought it meant that hundreds of young persons would be receiving financial assistance for their academic studies.

The $8.5 billion that CIRM will have spent by the time the cash runs is a lot of money. It shrinks rapidly, however, when individual clinical trial grants run as high as $20 million and companies receive more than $70 million without producing a commercial therapy, as is the case with a San Diego firm called Viacyte. That is not to mention mandates from the proposition that lock in spending. That includes the $1.5 billion that must go for diseases affecting the brain and nervous system, regardless of whether better opportunities exist in another field for actually producing a cure for some other terrible affliction.

How CIRM juggles these sorts of issues and even more complex questions will be an existential test for the enterprise and its leaders. If they make good bets about the science and the direction of the industry, both of which require a global perspective, and if they have a generous dollop of luck, all that will go a long way in determining whether CIRM will survive after the dollars run out in another decade or so.Editors Note: DavidJensen is a retired newsman and has followed the agency since 2005 on his newsletter, the California Stem Cell Report.

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The epithelial cell culture media market is expected to reach US$ 303,040.33 thousand by 2028 from US$ 128,155.95 thousand in 2020; it is estimated to grow at a CAGR of 11.4% from 2021 to 2028.

According The Insight Partners study on Epithelial Cell Culture Media Market Forecast to 2028 COVID-19 Impact and Global Analysis by Product Type, End User, The report highlights trends existing in the market, and drivers and hindrances pertaining to the market growth. The growth of the epithelial cell culture media market is attributed to the factors such as the increasing applications of epithelial cells and surge in funding for epithelial cell research.

Epithelial cells are widespread throughout the body. These cells cover body surfaces, line body cavities, hollow organs, and major tissues in glands. These cells perform functions such as protection, absorption, secretion, excretion, diffusion, filtration, and sensory reception. These cells are widely used in disease modeling, toxicity studies, and drug discovery, among other applications.

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Market Insights

Surge in Funding for Epithelial Cell Research

Extensive funding for supporting the research projects involving the use of epithelial cells to identify new therapeutic solutions for chronic diseases is propelling the demand for epithelial cell culture media. For instance, the National Institutes of Health (NIH), US, funded a 3-year research project (20132016) that was conducted at the University of Kentucky. The institute granted US$ 307,395 in funds in 2014 to examine processes controlling inflammation in colitis, a condition that stimulates epithelial stem cell growth and differentiation and increases the risk of colon cancer.

In 2018, scientists at the UCLA Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research along with those at the Stein Eye Institute were granted US$ 5.1 million by the California Institute for Regenerative Medicine to advance the development of a novel therapy for blinding retinal conditions. The project setup includes the use of patients own skin cells to generate autologous induced pluripotent stem cells to derive retinal pigment epithelium cells that are lost in blinding eye conditions.

Further, the Osaka University, Japan, conducted a research studyObservation of the Epithelial Cell Behavior in the Nasal Septum During Primary Palate Closure in Mice. This study was supported by Grants-In-Aid for Scientific Research Program of the Japan Society for the Promotion of Science. The increase in such grants for epithelial cell-based research projects are favoring the epithelial cells culture market growth.

COVID-19 first began in Wuhan (China) during December 2019 and since then it has spread at a fast pace across the globe. The US, India, Brazil, Russia, France, the UK, Turkey, Italy, and Spain are some of the worst affected countries in terms confirmed cases and reported deaths. The COVID-19 has been affecting economies and industries in various countries due to lockdowns, travel bans, and business shutdowns.

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By product type, the epithelial cell culture media market is segmented into human mammary epithelial cells, bronchia/trachea epithelial cells, and renal epithelial cells. The bronchia/trachea epithelial cells segment held the largest share of the market in 2020, whereas the renal epithelial cell segment is anticipated to register the highest CAGR in the market during the forecast period.

Based on end user, the epithelial cell culture media treatment market is segmented into biopharmaceutical companies, academic and research laboratories, and others. The biopharmaceutical companies segment held the largest share of the market in 2020, whereas the academic and research laboratories segment is anticipated to register the highest CAGR of in the market during the forecast period.

Epithelial Cell Culture Media Market : Competitive Landscape and Key Developments

PromoCell GmbH,Merck KGaA,ATCC,AXOL Bioscience Ltd.,Thermo Fisher Scientific Inc.,Bio-Techne Corporation, Celprogen Inc.,Lonza Group AG,HiMedia Laboratories,Cell Biologics Inc

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Epithelial Cell Culture Media Market to hit US$ 303040.33 thousand by 2028, at 11.4% CAGR: The Insight Partners - Digital Journal

In the ultimate quest for longevity and optimal health, many are turning to the latest trend, biohacking. The self-guided, experimental hack-your-way-to-better-health phenomenon has gained in popularity over the years and is making its way to the masses. You may have heard Twitter Co-founder Jake Dorsey endorsing the practice when he told his followers he benefited from intermittent fasting and drinking salt juice each morning. Or maybe youve heard of biohacker influencer Josiah Zayner who injected himself with DNA from a gene-editing technology. Or maybe you have a friend who tracks their sleep and diet down to the minute.

These are all different types of biohacking, and the term itself can mean something different depending on who you ask. So, with all the uncertainty we asked medical and health professionals some of the most commonly asked questions around the latest Silicon Valley wellness trend.

Finding a clear and concise definition of biohacking can be hard, but in general it refers to human augmentation or enhancement aimed at improving ones performance, health and overall life. Many experts have called it do-it-yourself-biology as more people are taking their health into their own hands, and forgoing seeking traditional medical advice for any ailments or health-related problems they might be facing.

Some examples include meditation or gratitude practice where an individual takes time out of their day to pause and reflect in hopes that they will feel more centered or grounded overtime. Other biohackers ingest nootropics or smart drugs that claim to enhance memory or boost brain performance. While the extreme side of biohacking can involve someone implanting a chip into their hand so they can pay for their daily coffee with a swipe of their wrist. Or some have even harvested stem cells from their own bone marrow just to re-inject themselves with those cells to attempt to slow their body from aging.

On a fundamental level, people attempt to biohack because they want to feel better and be their best possible self. For some, living as long as possible is their ultimate goal, while others simply dont want to suffer from the same disease their family members did.

Samantha Terrin, a social worker from Des Moines, Iowa says she started biohacking when her great aunt passed away from breast cancer.

The term biohacking carries a lot of negative stereotypes, and to be very clear, I do not subscribe to any of that pseudoscience, she said. However, I do believe that knowing what cancers my relatives had and what mental health struggles they carried with them, can better prepare me and protect me as I get older.

Terrin completed an in-depth DNA test to better understand her heritage and know what medical concerns her family had. I have not drank the kool-aid of biohacking, but if getting an in-depth DNA test is biohacking, well I guess Im a biohacker, she said.

What differentiates biohacking from other medical practices is the mindset. Many people biohack from the school of thought that their bodies shortcomings can be overcome, and its up to them to determine how and what to do to correct that. Dr. Jessica Madden, board-certified pediatrician and neonatologist, International Board Certified Lactation Consultant and Medical Director of Aeroflow Breastpumps says that while mild forms of biohacking like minor dietary changes might be okay, the practice should be approached with great caution. I have a lot of concerns about the more extreme forms of it, such as implanting magnets into bodies and DIY blood transfusions, she said. Therefore, I do not recommend biohacking to anyone.

And the more extreme forms of biohacking are what brought the medical community and even the FDA out to the forefront of the biohacking conversation. So much so that in February of 2019, the FDA made a statement warning against young blood transfusions. If youre unfamiliar with the treatment, its where an older person buys blood from a younger person and has it injected into their veins in hopes that it will slow their aging process. Another practice is a fecal transplant, which is exactly what it sounds like. Its the transferring of stool from a healthy donor into the gastrointestinal tract of an unhealthy person. The practice has been regularly denounced by medical professionals and is still not approved by the FDA.

And with biohacking gaining momentum, the question around the legality of the practice has only just begun. Current regulations are not designed to regulate or legislate biohacking, which means that many biohackers have found themselves operating in a gray zone, while the FDA and regulators do their best to keep up. California was the first state to require all gene therapy kits to come with a warning label that the kits are not safe to administer.

Dr. Madden also heavily warns against ingesting biohacking supplements that are not FDA regulated. They can contain toxic levels of heavy metals, such as mercury and lead, which can cause nerve and cell damage, she said.

With the conversation around biohacking often lending itself to extremes, some experts suggest reframing the term and hacking your health into simple and manageable ways. Dr. Aimee Eyvazzadeh recommends that women start biohacking their menstrual cycle by understanding their own bodys hormones and natural rhythms.

Just understanding what your hormones are doing and when in her cycle, can help a woman manage stress better, meal plan and plan her social and work schedule, she said. If you dont know how your hormones change throughout the cycle you should. Its a powerful way of harnessing your bodys energy into greatness.

Other experts agree that minor changes like assessing your nutrition, movement, sleep and stress can tremendously improve your overall lifestyle, and ultimately hack your health. Danielle Oldfield, a registered dietitian and holistic lifestyle coach says that writing down small goals that are achievable is a great place to start.

But regardless of what biohacks you seek to implement into your life, experts agree that you should consult with your doctor before making any sweeping health decisions.

I think it is amazing that people want to take charge of their own health, and find what resonates with them the most, said Oldfield. However one has to be careful not to fall trap to nonsense literature, and really make sure that you are getting your information from a scientific and peer-reviewed source. Everyone has a good enough reason why one thing works, but we do need to realize that health is not a one-size-fits-all.

Before you go, check out some of our favorite quotes for cultivating positive attitudes about food and bodies:

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What is Biohacking? Understanding the Silicon Valley Wellness Trend Youll Hear About in 2022 - SheKnows

It sounds like a fairy tale steeped in HIV stigma: A woman wakes up one morning and, poof, the HIV she's been living with for 8 years is gone. But for a 30-year-old Argentinian woman from the aptly named village of Esperanza, that's close to the truth, according to an article published in Annals of Internal Medicine.

The woman, the so-called Esperanza Patient, appears to be the second person whose immune system cleared the virus without the use of stem cell transplantation. The first was Loreen Willenberg, a California woman who, after living with HIV for 27 years, no longer had replicating HIV in her system. That case was reported last year.

"That's the beauty of this name, right? Esperanza," said Xu Yu, MD, principal investigator of the Ragon Institute of Massachusetts General Hospital, the Massachusetts Institute of Technology, and Harvard University, Boston, Massachusetts, referring to the Spanish word for "hope." "This makes us hopeful that a natural cure of HIV is actually possible."

Two other people appear to have cleared HIV, but only after full replacement of the immune system via stem cell transplantation the Berlin Patient, Timothy Ray Brown, and the London Patient. Another man, from Brazil, appeared to have an undetectable viral load after receiving intensified antiretroviral treatment plus supplemental vitamin B3.

The Esperanza Patient is among a rare group of people living with HIV called elite controllers. These people's immune systems can control HIV without antiretrovirals. Most elite controllers' immune systems, however, can't mount the immune attack necessary to eliminate all replicating HIV from their systems. Instead, their immune systems control the virus without affecting the reservoirs where HIV continues to make copies of itself and can spread.

The Esperanza Patient and Willenberg, however, appear to be the rarest of the rare. Their own immune systems seem not only to have stopped HIV replication outside of reservoirs but also to have stormed those reservoirs and killed all virus that might have continued to replicate.

The two women are connected in another way: At an HIV conference in 2019, Yu was presenting data on Willenberg's case. At that conference, she met Natalia Laufer, MD, PhD, associate researcher at the Instituto de Investigaciones Biomdicas en Retrovirs y SIDA at the University of Buenos Aires. Laufer had been studying the Esperanza Patient at the time and asked Yu whether she and her team at the Ragon Institute could help her sequence the patient's HIV genome to see whether, indeed, the virus had been spontaneously cleared from the patient's system.

So that's what the pair did, in collaboration with several other researchers into cures for HIV. The Esperanza Patient first acquired HIV in 2013, but in the 8 years that followed, results of 10 conventional viral load tests indicated the virus was undetectable (ie, below the level of quantification for standard technology). During that time, the woman's boyfriend, from whom she had acquired HIV, died of AIDS-defining illnesses. She subsequently married and had a baby. Both her partner and baby are HIV negative. She only received HIV treatment for 6 months while she was pregnant.

Yet, there was still HIV in the woman's system. Laufer and Yu wanted to know whether that HIV was transmissible or whether it was a relic from when HIV was still replicating and was now defective and incapable of replicating. They performed extensive genome sequencing on nearly 1.2 billion cells that Laufer had taken from the patient's blood in 2017, 2018, 2019, and 2020, an additional 503 million cells that were from the placenta of the baby she gave birth to in 2020, and 150 million resting CD4 T cells. Proviral sequencing was undertaken of the full DNA of the HIV to detect whether the virus was still intact. The DNA was then analyzed by use of an algorithm and was tested for mutations. The investigators tested the patient's CD4 cells to determine whether the cells still harbored any latent HIV.

In this way, they conducted a full viral workup using tests that are far more sensitive than the viral load tests the woman had undergone in the clinic. Theinvestigators then assessed the patient's immune system to see what the various cells of the immune system could tell them about how well her natural immune system could identify and kill HIV. They isolated the Esperanza Patient's immune cells and subjected those cells to HIV in the lab to see whether the cells could detect and eliminate the virus.

And just to be safe, they checked to make sure there were no antiretroviral drugs in the patient's system.

What they found was that without treatment, her CD4 count hovered around 1000 cells a sign of a functioning immune system. DNA sequences revealed large chunks of missing DNA, and one sequence had an immune-induced hypermutation. In total, seven proviruses were found, but none were capable of replicating. The CD4 cells they evaluated showed no evidence of latent HIV.

In other words, they had uncovered a fossil record.

"These HIV-1 DNA products clearly indicate that this person was infected with HIV-1 in the past and that active cycles of viral replication had occurred at one point," Yu and colleagues write in their recent article.

What may be more useful to researchers looking to turn this spontaneous cure into treatment for millions of people living with active HIV was the evidence that the woman's immune system had trained itself to attack HIV through a number of genetic mutations. What they found, the researchers write, was evidence of "an incomplete seroconversion" that is, when the patient was acquiring HIV, the infection was stopped in its tracks.

Yet, Yu and colleagues say that they can't prove that the woman is fully cured of HIV.

"Although this might sound unsatisfying, it reflects an intrinsic limitation of scientific research," they write. "Scientific concepts can never be proved through empirical data collection; they can only be disproved."

Are these women the only ones to have spontaneously cleared HIV? That's the question, said Carl Dieffenbach, PhD, director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. Just like they can't disprove that the women cured themselves, they can't prove that she and Willenberg are the only two people to have experienced this cure.

"We're all struggling with this," Dieffenbach told Medscape Medical News. "The goal is to get enough of these people so maybe there's a road map to how to induce, trigger, change immunity. But this could well be a unique event at the time of initiation of infection. We just don't know."

What is needed, Yu said, is for clinicians to reach out to them regarding cases that could mimic the cases of Willenberg and the Esperanza Patient. Elaborate testing could then be conducted to see whether thesecases are similar to those of Willenberg and the Esperanza Patient.

"We do think there are more out there," Yu told Medscape Medical News.

Asked whether we're still far away from applying these one-off cures to the millions of people taking HIV treatment daily, Yu responded, "We might be close. That's the beauty of scientific discovery. We don't know, but that's why we need more engagement of the community and care providers to help us."

The research was funded by the Bill and Melinda Gates Foundation and the National Institutes of Health. Yu and Dieffenbach have reported no relevant financial relationships.

Ann Intern Med. Published online November 16, 2021. Abstract

Heather Boerner is a science journalist based in Pittsburgh, Pennsylvania. Her book, Positively Negative: Love, Pregnancy, and Science's Surprising Victory Over HIV, was published in 2014.

For more news, follow Medscape on Facebook, Twitter, Instagram, and YouTube.

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Second Woman Spontaneously Clears HIV: 'We Think More Are Out - Medscape

TOKYO & MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--SanBio Company Limited (hereafter, the Company) hereby announces that it entered into a business partnership agreement with D&P Bioinnovations, Inc. (San Diego, California; hereafter, D&P), a US-based regenerative medicine company, regarding the development and commercialization of a medical device implant utilizing the Companys regenerative medicine MSC2 for the regeneration of esophageal tissue in humans on November 15, 2021.

1. Overview of the business partnership

Under the partnership agreement, SanBio will grant D&P a non-exclusive, non-transferable license to use MSC2 for the development and commercialization of the latters regenerative esophageal implant. In return, the Company will receive rights to commercialize D&Ps regenerative esophageal implant in Japan, as well as first negotiation rights to commercialize the implant in other parts of Asia. Further, the Company will receive tiered royalties (up to 2.5%) for D&Ps sales of the implant outside Japan. In case D&P out-licenses its regenerative esophageal implant to a third party, the Company will be entitled to a certain proportion (up to 20%) of the profits D&P earns from out-licensing the implant.In terms of major expenses, SanBio will cover expenses required for the development of manufacturing processes of MSC2 while D&P will shoulder expenses for the development of the regenerative esophageal implant in all countries except Japan.

Keita Mori, CEO of SanBio, commented as follows on the partnership agreement:D&P has extensive knowledge and highly specialized expertise in the field of regenerative esophageal implants. We believe our collaboration with D&P, which includes the supply of MSC2, will lead to development of a medical device implant that can provide substantial potential benefits to patients suffering from esophageal damages.

Dr. Derek Dashti, CEO of D&P, commented as follows:We at D&P Bioinnovations are pleased to cooperate with SanBio, a leader in regenerative medicine research development, in our development of regenerative esophageal implants. D&P is a regenerative medicine company focused on repairing damaged tissue/organs with engineered biomaterials and stem cells. We look forward to collaborating with SanBio on the development of our off-the-shelf engineered platform organ regenerative implant for our first application to treat and regenerate a severely damaged esophagus due to cancer, illness, and/or physical trauma. This collaboration is exciting to continue our work in changing and translating the paradigm of regenerative medicine therapeutics through the use of D&Ps novel engineered off-the-shelf tissue/organ regenerative implants.

2. Overview of business partner

(1)

Company name

D&P Bioinnovations, Inc.

(2)

Location

San Diego, California, the U.S.A.

(3)

Name and position ofrepresentative

Derek Dashti, CEO

(4)

Main business

Development of platform tissue/organ regenerative implants: 1st application to develop regenerative esophageal implants.

(5)

Date established

March, 2015

3. Outlook

The impact of the newly published analytical results on earnings for the current fiscal year (ending January 2022) is expected to be marginal, but the Company thinks the partnership will contribute to enhancing its performance in the medium to long term.

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Business Partnership for Development and Commercialization of Medical Device Implant Utilizing MSC2 for the Regeneration of Esophageal Tissue in...

BUFFALO, N.Y. The global race to develop new stem cell-based COVID-19 treatments during the pandemic was filled with violations of government regulations, inflated medical claims and distorted public communication, say the authors of a new perspective published Oct. 14 in the journal Stem Cell Reports.

While stem cell therapy using stem cells to promote regeneration, repair or healing may be used to treat a limited number of diseases and conditions, there are currently no clinically tested or government-approved cell therapies available for the treatment or prevention of COVID-19 or its long-term effects.

However, this has not stopped the emergence of clinics offering unproven and unsafe stem cell therapies that promise to prevent COVID-19 by strengthening the immune system or improving overall health, says lead author Laertis Ikonomou, PhD, associate professor of oral biology in the University at Buffalo School of Dental Medicine.

The article explores the negative effects that misinformation about cell therapies has on public health, as well as the roles that researchers, science communicators and regulatory agencies should play in curbing the spread of inaccurate information and in promoting responsible, accurate communication of research findings.

Efforts to rapidly develop therapeutic interventions should never occur at the expense of the ethical and scientific standards that are at the heart of responsible clinical research and innovation, says Ikonomou.

Scientists, regulators and policymakers must guard against the proliferation of poorly designed, underpowered and duplicative studies that are launched with undue haste because of the pandemic, but are unlikely to provide convincing, clinically meaningful safety and efficacy data, says co-author Leigh Turner, PhD, professor of health, society and behavior at the University of California, Irvine.

Other investigators include Megan Munsie, PhD, professor of ethics, education and policy in stem cell science at the University of Melbourne; and Aaron Levine, PhD, associate professor of public policy at Georgia Institute of Technology.

Unsafe products linked to unproven claims

Many of the studies on possible stem cell-based COVID-19 treatments are at an early stage of investigation and further evaluation on larger sample sizes is required, says Munsie. However, the findings from preliminary studies are frequently exaggerated through press releases, social media and uncritical news media reports.

Given the urgency of the ongoing pandemic, even the smallest morsel of COVID-19 science is often deemed newsworthy and rapidly enters a social media landscape where regardless of its accuracy it can be widely shared with a global audience, says Levine.

Clinics selling supposed stem cell treatments on a direct-to-consumer basis sometimes use these findings and news reports to exploit the fears of vulnerable patients by unethically advertising the unproven benefits of stem cell treatments to boost the immune system, regenerate lung tissue and prevent transmission of COVID-19, says Turner.

There are reports of patients suffering physical harm including blindness and death from unproven stem cell therapies. Patients suffer financially as well, says Ikonomou, as the products range in price from a few thousand to tens of thousands of dollars, and people are often encouraged to receive the expensive treatments every few months.

Patients led to believe they are protected against COVID-19 may decide against vaccination, stop wearing masks, cease engaging in physical distancing, or otherwise avoid behaviors intended to promote personal safety and public health, says Turner. They may also become less likely to take part in carefully-developed clinical trials conducted by companies that follow ethical standards.

The premature commercialization of cell-based therapeutics will inevitably harm the field of regenerative medicine, increase risks to patients and erode the publics trust, says Ikonomou.

Taking stronger action

The United States Food and Drug Administration and Federal Trade Commission have issued warnings to numerous offending clinics, yet many companies continue to make false claims.

The authors recommend that regulatory agencies consider implementing stronger measures to deter the sale of unlicensed products, such as issuing fines or criminal charges, revoking medical licenses or forcing clinics to return money to patients.

They also suggest that scientific and professional societies lobby regulatory agencies to increase enforcement of laws and regulations. Science communicators and journalists can combat misinformation by not engaging in hyperbolic coverage of research results and conveying study limitations, say the authors.

###

Stem Cell Reports

Ethical issues and public communication in the development of cell-based treatments for COVID-19: Lessons from the pandemic

14-Oct-2021

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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NEW YORK, Oct. 14, 2021 /PRNewswire/ --BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, will present findings from a multicenter, open label clinical trial of NurOwn in progressive multiple sclerosis. The study, "Phase 2 Safety and Efficacy Study of Intrathecal MSC-NTF cells in Progressive Multiple Sclerosis," will be delivered in an oral presentation today at the fully digital37thCongress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

The Phase 2 clinical trial was designed to evaluate intrathecal administration of NurOwn (autologous MSC-NTF cells) in participants with progressive MS. The study achieved the primary endpoint of safety and tolerability. It demonstrated a reduction of neuroinflammatory biomarkers and an increase in neuroprotective biomarkers in the cerebrospinal fluid (CSF) and consistent improvement across MS functional outcome measures, including measures of walking, upper extremity function, vision and cognition.

"We were pleased that this study demonstrated safety, preliminary evidence of efficacy and relevant biomarker outcomes in patients with progressive multiple sclerosis, in an area of high unmet need," said Jeffrey Cohen, M.D., Director of Experimental Therapeutics at the Cleveland Clinic Mellen Center for MS and principal investigator for the trial. "These results should be confirmed in a randomized placebo-controlled trial."

The study was sponsored by Brainstorm Cell Therapeutics with additional financial support for biomarker analyses from the National Multiple Sclerosis Society Fast-Forward Program. It was conducted at four U.S. MS centers of excellence:

"We very much appreciate the tremendous collaboration among many premier organizations, for their generous sharing of expertise, support and data, which enabled the important balance between scientific rigor and ethical treatment of progressive MS participants in the trial," said Ralph Kern, M.D., MHSc., President and Chief Medical Officer, Brainstorm Cell Therapeutics. "We are holding discussions with key MS experts, and seeking guidance from the FDA to determine next steps for the development of NurOwn in progressive MS."

"The National MS Society is pleased to support the biomarker portion of this study through our commercial funding program Fast Forward," said Mark Allegretta, Ph.D., Vice President, Research. "We're encouraged to see evidence that the biomarker analysis showed proof of concept for detecting neuroprotection and reduced inflammation."

About the trial

The Phase 2 open-label studyevaluated the safety and efficacy of intrathecal administration of autologous MSC-NTF cells in patients with primary or secondary progressive MS. The primary study endpoint was safety and tolerability. Secondary efficacy endpoints included: timed 25-foot walk (T25FW); 9-Hole Peg Test (9-HPT); Low Contrast Letter Acuity (LCLA); Symbol Digit Modalities Test (SDMT); 12 item MS Walking Scale (MSWS-12); as well as cerebrospinal fluid (CSF) and blood biomarkers. Clinical efficacy outcomes were compared with matched (n=48) participants in the Comprehensive Longitudinal Investigation of Multiple Sclerosis (CLIMB) registry, Tanuja Chitnis, MD Brigham and Women's Hospital and the Ann Romney Center for Neurologic Diseases, and 255 patient randomized double blind placebo controlled NN-102 SPRINT-MS Study, courtesy NIH/NINDS, PI: Robert J. Fox, MD, MS, FAAN, Cleveland Clinic, CTR: NCT01982942. Baseline characteristics from these two cohorts were similar allowing for comparison of efficacy results, comparisons with SPRINT-MS were with the placebo arm of this study.

Mean age of participants was 47 years, 56% were female, and mean baseline EDSS score was 5.4. 18 participants were treated, 16 (80%) received all 3 treatments and completed the entire study; 2 study discontinuations were due to procedure-related adverse events. No deaths or treatment-related adverse events due to worsening of MS were observed.

In responder analyses, 14% and 13% of MSC-NTF treated participants showed at least a 25% improvement in T25FW and 9-HPT (combined hands) respectively, compared to 5% and 0% in matched CLIMB patients and 9% and 3% in SPRINT. Twenty-seven percent (27%) showed at least an 8-letter improvement in LCLA (binocular, 2.5% threshold) and 67% showed at least a 3-point improvement in SDMT, compared to 6% and 18% in CLIMB and 13% and 35% in SPRINT, respectively.

Mean improvements of +0.10 ft/sec in T25FW and -0.23 sec in 9-HPT (combined hands), were observed in MSC-NTF treated participants, compared to a mean worsening of -0.07 ft/sec and +0.49 sec in CLIMB and -0.06 ft/sec and +0.28 sec in SPRINT, respectively. MSC-NTF treated participants showed a mean improvement of +3.3 letters in LCLA (binocular, 2.5% threshold) and 3.8 points in SDMT, compared to a mean worsening of -1.07 letters in LCLA (binocular, 2.5% threshold) and mean improvement of +0.10 in SDMT, in CLIMB and -0.6 and -0.1 in SPRINT. In addition the MSFC-4 Composite Z-score of T25W, 9-HPT, SDMT and LCLA showed a 0.18 point improvement in MSC-NTF treated participants, while CLIMB and SPRINT showed decreases of -0.02 and -0.05.

Furthermore, 38% of treated patients showed at least a 10-point improvement in the MSWS-12 a patient reported outcome that evaluates the impact of MS on walking function, whereas this outcome was not evaluated in CLIMB or SPRINT.

CSF biomarkers obtained at 3 consecutive time points, showed increases in neuroprotective molecules (VEGF, HGF, NCAM-1,Follistatin, Fetuin-A) and decreases in neuroinflammatory biomarkers (MCP-1, SDF-1, sCD27 and Osteopontin).

About NurOwn

The NurOwntechnology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwntechnology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

For more information, visit the company's website atwww.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwnmanufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect,""likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwntreatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwntreatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwntreatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts:

Investor Relations:Eric GoldsteinLifeSci Advisors, LLCPhone: +1 (646) 791-9729egoldstein@lifesciadvisors.com

Media:Mariesa Kemble kemblem@mac.com

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