Category Archives: California Stem Cells

StemExpress to use utilize the Thermo Fisher Accula rapid PCR testing system to provide event attendees with accurate results in 30 minutes.

Published: Oct. 5, 2021 at 2:33 PM CDT|Updated: 4 hours ago

SACRAMENTO, Calif., Oct. 5, 2021 /PRNewswire/ --StemExpress is proud to announce that they will be the official COVID-19 testing provider for 2021's Meeting on the Mesa, a hybrid event bringing together great minds in the cell and gene biotech sphere. It has partnered with Alliance for Regenerative Medicine to comply with the newly implemented California state COVID-19 vaccination and testing policy regarding gatherings with 1,000 or more attendees. This partnership will allow the vital in-person networking aspect of the event to commence while protecting the health and safety of participants and attendees.

In-person networking commences at the 2021 Cell and Gene Meeting on the Mesa with COVID-19 testing options provided by StemExpress.

As a leading global provider of human biospecimen products, StemExpress understands the incredible impact that Meeting on the Mesa has on the industry and has been a proud participant for many years. For over a decade, StemExpress has provided the cell and gene industry with vital research products and holds valued partnerships with many of this year's participants. As such, it understands the immense value that in-person networking provides and is excited to help bring this element back to the meeting safely and responsibly.

StemExpress has been a trusted provider of widescale COVID-19 testing solutions since early 2020 - providing testing for government agencies, public health departments, private sector organizations, and the public nationwide. For Meeting on the Mesa, StemExpress is offering convenient testing options for unvaccinated attendees and those traveling from outside of the country. Options will include take-home RT-PCR COVID Self-Testing Kits and on-site, rapid PCR testing for the duration of the event. The self-testing kit option allows attendees to test for COVID in the days leading up to the event for a seamless admission and the days following the event to confirm they haven't been exposed. The on-site rapid testing option utilizes the new Thermo Fisher Accula, offering in-person testing at the event with results in around 30 minutes. StemExpress is excited to bring these state-of-the-art COVID testing solutions to the frontlines of the Cell & Gene industry to allow for safe in-person connections.

The StemExpress partnership with Alliance for Regenerative Medicine seeks to empower the entire cell and gene industry with a long-awaited opportunity to return to traditional networking practices. It is well known that innovation doesn't exist in a vacuum - allowing great minds to come together is a sure way to spur scientific growth and advance cutting-edge research, giving hope for future cures.

Cell and Gene Meeting on the Mesa will take place October 12th, 2021, through October 14th, 2021, at Park Hyatt Aviara,7100 Aviara Resort Drive Carlsbad, CA 92011. To learn more about the event, please visit MeetingOnTheMesa.com.

For more information about COVID testing solutions for businesses and events, visit https://www.stemexpress.com/covid-19-testing/.

About StemExpress:

Founded in 2010 and headquartered in Sacramento, California, StemExpress is a leading global biospecimen provider of human primary cells, stem cells, bone marrow, cord blood, peripheral blood, and disease-state products. Its products are used for research and development, clinical trials, and commercial production of cell and gene therapies by academic, biotech, diagnostic, pharmaceutical, and contract research organizations (CRO's).

StemExpress has over a dozen global distribution partners and seven (7) brick-and-mortar cellular clinics in the United States, outfitted with GMP certified laboratories. StemExpress runs its own non-profit supporting STEM initiatives, college and high school internships, and women-led organizations. It is registered with the U.S. Food and Drug Administration (FDA) and is continuously expanding its network of healthcare partnerships, which currently includes over 50 hospitals in Europe and 3 US healthcare systems - encompassing 31 hospitals, 35 outpatient facilities, and over 200 individual practices and clinics.

StemExpress has been ranked by Inc. 500 as one of the fastest-growing companies in the U.S.

About the Alliance for Regenerative Medicine:

The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies. ARM promotes legislative, regulatory, reimbursement and manufacturing initiatives to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-based therapies. Early products to market have demonstrated profound, durable and potentially curative benefits that are already helping thousands of patients worldwide, many of whom have no other viable treatment options. Hundreds of additional product candidates contribute to a robust pipeline of potentially life-changing regenerative medicines and advanced therapies. In its 12-year history, ARM has become the voice of the sector, representing the interests of 400+ members worldwide, including small and large companies, academic research institutions, major medical centers and patient groups. To learn more about ARM or to become a member, visit http://www.alliancerm.org.

Media Contact: Anthony Tucker, atucker@stemexpress.com

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StemExpress Partners with the Alliance for Regenerative Medicine to Provide COVID-19 Testing for the Cell and Gene Meeting on the Mesa - WSAW

Published: Oct. 4, 2021 at 6:00 AM EDT

NEW YORK, Oct. 4, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today that Stacy Lindborg, Ph.D., Executive Vice President and Head of Global Clinical Research, will deliver a presentation at the2021 Cell & Gene Meeting on the Mesa, being held as a hybrid conferenceOctober 12-14, and October 19-20, 2021.

Dr. Lindborg's presentation highlights the expansion of Brainstorm's technology portfolio to include autologous and allogeneic product candidates, covering multiple neurological diseases. The most progressed clinical development program, which includes a completed phase 3 trial of NurOwn in ALS patients, remains the highest priority for Brainstorm. Brainstorm is committed to pursuing the best and most expeditious path forward to enable patients to access NurOwn.

Dr. Lindborg's presentation will be in the form of an on-demand webinar that will be available beginning October 12. Those who wish to listen to the presentation are required to registerhere. At the conclusion of the 2021 Cell & Gene Meeting on the Mesa, a copy of the presentation will also be available in the "Investors and Media" section of the BrainStorm website underEvents and Presentations.

About the 2021 Cell & Gene Meeting on the Mesa

The meeting will feature sessions and workshops covering a mix of commercialization topics related to the cell and gene therapy sector including the latest updates on market access and reimbursement schemes, international regulation harmonization, manufacturing and CMC challenges, investment opportunities for the sector, among others. There will be over 135 presentations by leading public and private companies, highlighting technical and clinical achievements over the past 12 months in the areas of cell therapy, gene therapy, gene editing, tissue engineering and broader regenerative medicine technologies.

The conference will be delivered in a hybrid format to allow for an in-person experience as well as a virtual participation option. The in-person conference will take place October 12-14 in Carlsbad, CA. Virtual registrants will have access to all content via livestream during program dates. Additionally, all content will be available on-demand within 24 hours of the live program time. Virtual partnering meetings will take place October 19-20 via Zoom.

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.

ContactsInvestor Relations:Eric GoldsteinLifeSci Advisors, LLCPhone: +1 646.791.9729egoldstein@lifesciadvisors.com

Media:Paul TyahlaSmithSolvePhone: + 1.973.713.3768Paul.tyahla@smithsolve.com

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SOURCE Brainstorm Cell Therapeutics Inc

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BrainStorm to Present at the 2021 Cell & Gene Meeting on the Mesa - WWNY

The University of California, Davis, set a new record for external research funding, receiving $968 million in awards in the fiscal year 2020-21, up $27 million from the previous record set last year. A major reason for this years growth was increased funding related to medicine and public health.

Professors Diana Farmer and Aijun Wang are collaborating to develop a stem cell treatment for spina bifida. (2019)

The School of Medicine received the largest increase in funding, up $92 million from the previous year, for a total of $368 million. Funding related to COVID-19 research totaled $42 million for the year. Studies in this area are providing critical insight into testing, vaccines, treatments and social impacts.

We are very proud of our researchers at the School of Medicine who rose to the challenge and expanded their groundbreaking work in the face of the pandemic, said Allison Brashear, dean of the UC Davis School of Medicine. All our research teams have shown great agility and collaboration across disciplines, quickly responding to emerging needs to prevent transmission and find treatments and vaccines to combat COVID-19, while also offering patients life-saving clinical trials in areas involving stem cell treatments, cancer and neuroscience, among many others.

Brashear noted that the School of Medicines clinical trials grew by 63% in the last year to $98 million.

The College of Agricultural and Environmental Sciences ($153 million), School of Veterinary Medicine ($83 million), College of Engineering ($80 million) and College of Biological Sciences ($58 million) rounded out the top five recipients.

This achievement reflects the unwavering commitment of our research community and their passion to address important societal needs during a year when operations were constrained due to the COVID-19 pandemic, Chancellor Gary S. May said. The societal impact of UC Davis research is far-reaching, spanning geographical boundaries and catering to diverse populations and needs.

The awards enable a broad range of research on topics including advancing human and animal health, protecting our planet and food supply and enabling a more resilient society.

The largest award, $51 million from the Department of Health and Human Services Centers for Disease Control and Prevention, went to Marc Schenker, distinguished professor of Public Health Sciences, to improve public health outcomes for all Californians by providing proper disease surveillance and prevention.

The federal government remains the largest provider of funding at $514 million, up $37 million from last year. The second leading source came from the state of California at $164 million, up $32 million. Funding from industry made up the third highest source, totaling $116 million, up $31 million.

UC Davis researchers received a total of 18 NSF CAREER Awards, a record for the university. These prestigious grants are offered to early-career faculty who have the potential to serve as academic role models in research and education and to lead advances in the mission of their department or organization.

Collaborative research bringing experts together from different fields of study continues to attract significant funding. These joint efforts often focus on addressing complex, large-scale challenges that require expertise from many perspectives.

We continue to see how multidisciplinary research provides a distinct advantage in tackling multifaceted issues, said Prasant Mohapatra, vice chancellor for Research at UC Davis. As one of the most academically comprehensive universities in the world, UC Davis offers a unique environment to solve these complex issues by bringing together experts from across our campuses.

Notable multidisciplinary awards include a $16 million grant from the National Institute of Mental Health for the UC Davis Conte Center to explore how infections in pregnancy lead to disorders in offspring. Principal investigators on this grant are Kimberly McAllister and Cameron Carter.

The Interdisciplinary Research and Strategic Initiatives division within the Office of Research offers support and resources to help teams advance their programs. Some of the notable interdisciplinary research projects include the work of Sheryl Catz, professor at the UC Davis Betty Irene Moore School of Nursing. Catz received $225,000 from the NIH National Cancer Institute for a project to improve the reach and effectiveness of smoking cessation services targeted to veterans living with HIV.

Diana Farmer, professor and chair in the Department of Surgery at UC Davis Health, also received $9 million from the California Institute for Regenerative Medicine (CIRM). Farmer is the principal investigator of the clinical trial, known formally as The CuRe Trial a cellular therapyfor in utero repair of myelomeningocele which uses stem cells before birth to treat the most serious form of spina bifida.

This story was originally written by Neelanjana Gautam and published here.

Note: Where funds are awarded up-front to cover several years, the money is counted in the first year the award was received. Incrementally funded awards are counted as authorized in each year. Reports are based on the principal investigators home school or college.

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UC Davis and the School of Medicine set new records in research funding - UC Davis Health

Bayer subsidiary BlueRock Therapeutics has been granted a fast-track review by the FDA for DA01, its stem cell-based therapy for Parkinsons disease which is currently in early-stage clinical testing.

The FDA designation allows for benefits such as more frequent meetings and communication with the regulator during clinical development, and a truncated six-month review time.

Those are all considerations for the future as the first patients only started to be treated with DA01 in a phase 1 trial aimed primarily at showing the safety of the therapy, which is trying to replenish the dopaminergic neurons that progressively die away in Parkinsons and lead to slow, laboured movement, tremors and other symptoms.

The therapy involves implantation of dopamine-producing cells under general anaesthesia into a part of the brain called the putamen, which is particularly affected by neuron loss in Parkinsons and is responsible for regulating movement as well as some types of learning.

Patients take immune-suppressing drugs to prevent their body rejecting the transplanted cells, and the safety and tolerability of the procedure as well as the ability of the transplant to survive will be monitored for two years.

BlueRock is also hoping to demonstrate some evidence of efficacy, and will look at clinical measures such as motor function over the same time period. It is the first trial in the US to study pluripotent stem cell-derived dopaminergic neurons in patients with Parkinsons, according to the company.

The first patient in the trial, which will eventually enrol 10 subjects with advanced Parkinsons, was treated at Memorial Sloan Kettering Cancer Centre in June, and others will be recruited at Weill Cornell Medical Centre, the University of California, Irvine, and the University of Toronto.

Our objective is to use authentic cells, to have them integrate entirely into the brain and restore lost physiologic function, said BlueRock chief executive Emile Nuwaysir, as the first patient was treated.

If successful, this new therapeutic modality could have implications for the Parkinsons community and beyond, he added.

Bayer took control of BlueRock in 2019, three years after backing the formation of the company as joint venture with private equity group Versant, in a deal that valued the biotech at $1 billion.

DA01 is Bluerocks lead cell therapy programme, but the company is also working on treatments for other neurological disorders, degenerative heart disease, and autoimmune disorders.

Bayer is also developing a gene therapy for Parkinsons originated by Asklepios Bio (AskBio), which it acquired for $2 billion upfront last year with another $2 billion tied to milestones, and has pledged to make cell and gene therapies a pillar of its R&D strategy.

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FDA gives speedy review to Bayer's Parkinson's stem cell therapy - - pharmaphorum

SAN DIEGO, Calif. Can COVID-19 really make its way into the human brain? Its a question thats been on scientists minds for over a year. Now, a new study reveals that it is indeed possible for SARS-CoV-2 to infect certain brain cells. The revelation could go a long way to explaining the seemingly never-ending symptoms of long COVID.

Researchers from the University of California San Diego School of Medicine and Rady Childrens Institute for Genomic Medicine used a sophisticated stem cell model of brain cells and human neurons to make this discovery.

Clinical and epidemiological observations suggest that the brain can become involved in SARS-CoV-2 infection, says senior author and professor of neuroscience Joseph Gleeson, MD, in a university release.

The prospect of COVID19-induced brain damage has become a primary concern in cases of long COVID, but human neurons in culture are not susceptible to infection. Prior publications suggest that the cells that make the spinal fluid could become infected with SARS-CoV-2, but other routes of entry seemed likely.

A team of neuroscientists and infectious disease specialists first confirmed that human neural cells are actually resistant to the virus causing COVID-19. Unfortunately, their findings also reveal that other types of brain cells may be acting as a Trojan horse for coronavirus.

Study authors explain that pericytes are specialized cells that wrap themselves around blood vessels. These cells also carry the SARS-CoV2 receptor. Using a 3D neural cell culture, researchers added these pericytes to the mix to create assembloids a realistic model of the human body. The assembloids contained several types of brain cells, in addition to the pericytes.

After exposing this model to coronavirus, they discovered SARS-CoV-2 can infect pericytes and other cells. These brain cells then acted as local factories for the virus to multiply and spread.

Moreover, scientists found that once the virus starts to spread, it attacks astrocytes, a group of supporting cells in the body. The results show that one potential route for COVID entering the brain involves blood vessels carrying coronavirus-infected pericytes into the brain. From there the virus attacks other brain cells vulnerable to infection.

Alternatively, the infected pericytes could lead to inflammation of the blood vessels, followed by clotting, stroke or hemorrhages, complications that are observed in many patients with SARS-CoV-2 who are hospitalized in intensive care units, Gleeson adds.

Moving forward, researchers plan to build new assembloids that include blood vessels capable of pumping blood. This will provide an even better simulation of whats happening in the brain and how COVID-19 may be attacking people over the long haul.

The findings appear in the journal Nature Medicine.

Continued here:
Stem cell model reveals how COVID-19 can infect the brain - Study Finds

Researchers at the Chinese Academy of Sciences and University of Science and Technology of China have devised a novel bioprinting-based method of curing previously untreatable spinal cord injuries.

Using a custom bio-ink, the Chinese team have managed to 3D bioprint neural stem cell-loaded tissues capable of carrying instructions via impulses from the brain, much like those seen in living organisms. Once implanted into disabled rats, the scaffolds have shown the ability to restore movement in paralyzed limbs, and the scientists now believe their approach could find human applications in future.

There is no known effective cure for spinal cord injury, Zhijun Zhang, a nanobiomedical engineer at the Chinese Academy of Sciences told the Scientist. The 3D bioprinting strategy weve developed, may represent a general and versatile strategy for rapid and precise engineering of the central nervous system (CNS), and other neuronal tissues for regenerative medicine.

The SCI injury conundrum

A Spinal Cord Injury or SCI is a blanket term used to describe any damage caused to the bundle of cells and nerves that send signals to and from the brain along the human spinal cord. While the damage itself can be caused either by direct injury, or from bruising to the surrounding vertebrae, the result is often the same: a partial or complete loss of sensory and locomotor function below the affected area.

While theres no current known cure for SCI, a number of promising cell-based therapies are now being developed, with the regeneration of functional neurons seen as central to their future success. In effect, such approaches involve re-establishing links between neurons throughout the injured area in order to restore nerve functionality, but repairing damaged cells continues to be problematic.

Where neural stem cells have previously been implanted into SCI sites, theyve also shown poor viability and uncontrolled differentiation, leading to low therapeutic efficacy. More recent efforts have seen scientists bioprint cell-loaded scaffolds, capable of creating a suitable microenvironment in which neurons can flourish, yet this has raised further issues around printability and initiating cellular interaction.

To get around these problems, the Chinese researchers have now developed a novel bio-ink that gels together at body temperature to prevent neurons from differentiating into cells that dont produce electrical impulses, and can be 3D bioprinted into scaffolds that not only mimic the white matter appearance of the spine, but encourage cell-to-cell interactions.

A paralysis cure in-action

To begin with, Zhang and his team formulated their bio-ink from natural chitosan sugars, as well as a mixture of hyaluronic acids and matrigel, before combining them with rat neural stem cells. The scientists then used a BioScaffolder 3D bioprinter to deposit the resulting concoction into cell-laden scaffolds, which were later stored in culture plates for further testing.

Prior to their implantation, the teams different samples were incubated for three, five and seven days respectively, during which they proliferated and formed connections. Interestingly though, the researchers found that the higher the concentration of hyaluronic acid, the lower levels of interaction they observed, showing that their bio-ink can be tweaked to achieve desired tissue characteristics.

When injected into paraplegic lab rats, the scaffolds exhibited a cell viability of 95% while promoting neuron regeneration to the point that they enabled the rats to regain control over their hind legs. Over a 12-week observation period, the treated animals also showed a revived ability to move their hips, knees and ankles without support, and kick pressure sensors with markedly enhanced muscle strength.

As a result, the scientists have concluded that their approach offers a versatile and powerful platform for building precisely-controlled complex neural tissues with potential human applications, although they concede that more precise regulation of cell differentiation will be needed to achieve this, in addition to further testing on more clinically-relevant injury models.

Overall, this study clearly demonstrated for the first time the feasibility of the 3D bioprinted neural stem cell-laden scaffolds for SCI repair in-vivo, concluded the team in their paper, which, we expect, may move toward clinical applications in the neural tissue engineering, such as SCI and other regenerative medicine fields in the near future.

3D bioprinting in CNS treatments

Thanks to constant advances in flexible electronics and 3D bioprinting technologies, its now becoming increasingly possible to produce neural implants, with the potential to treat complex CNS injuries. Last year, a project started at TU Dresden led to the creation of 3D printed neural implants, capable of linking the human brain to computers as a means of treating neurological conditions such as paralysis.

In a similar study, engineering firm Renishaw has worked with pharmaceuticals expert Herantis Pharma to assess the performance of its 3D printed neuroinfuse drug delivery device. Designed to deliver intermittent infusions into the parenchyma, an organs functional tissue, the platform could be used as a future treatment for Parkinsons disease.

With regards to treating spinal injuries specifically, researchers at the University of California San Diego have also managed to repair spinal cord injuries in rats. By implanting 3D printed two-millimeter-wide grafts into test subjects, the team have been able to facilitate neural stem cell growth, restore nerve connections and ultimately help recover limb functionality in rodent test subjects.

The researchers findings are detailed in their paper titled 3D bioprinted neural tissue constructs for spinal cord injury repair. The study was co-authored by Xiaoyun Liu, Mingming Hao, Zhongjin Chen, Ting Zhang, Jie Huang, Jianwu Dai and Zhijun Zhang.

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Featured image shows the researchers 3D bioprinted scaffolds after 7 and 21 days culturing. Images via the Biomaterials journal.

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Introducing the 3D bioprinted neural tissues with the potential to 'cure' human paralysis - 3D Printing Industry

"Generate is certainly the best partner for Insception and Cells for Life in Canada given their industry and scientific leadership," says Brent Dennison, Insception's CEO. "The great benefit to our customers will be our collaboration with Generate's scientific team who are driving exciting developments in therapeutic applications using newborn stem cells. It delivers important value to the 100,000+ Canadian families who have banked their children's stem cells with our group." Mr. Dennison noted that clients and healthcare professionals will continue working with the Insception group's Canadian team. Insception and Cells for Life process and store newborn stem cells at Insception's state-of-the-art facility in Toronto.

"Newborn stem cells have unique properties that make them a preferred biological source for an increasing number of conditions," said Jaime Shamonki, MD, Generate's Chief Medical Officer. "The Insception group and CBR have conducted numerous clinical trials investigating the uses for cord blood and tissue derived-cells. Now, with Insception joining the largest newborn stem cell bank in the United States, we have created a global infrastructure for researching and manufacturing newborn stem cells to power this rapidly expanding category of therapies."

Stem cells derived from the umbilical cord have emerging uses in regenerative medicine given their anti-inflammatory, immune-modulating, and tissue reparative properties. The Insception group and Generate research and develop cord blood and tissue-derived cellular therapies through partnerships with leading academic institutions and biotech firms. Most recently, the Insception group helped establish a cord blood trial for preterm babies at risk of neurological damage and Generate has established a biorepository to facilitate investigational studies in both acute and persistent COVID-19 using newborn stem cells through their extensive network of research partners.

*This transaction is still pending approval from the Foreign Investment Review Board (FIRB) of Australia, which governs the Cell Care group.

About Generate Life SciencesGenerate Life Sciences Inc. is a life sciences company helping to grow and protect families through reproductive, newborn stem cell, genetic screening, medical device, and healthcare technology services. We serve families from preconception to post-birth. Our brands CBR (Cord Blood Registry), California Cryobank, Donor Egg Bank USA, NW Cryobank, ReadyGen, Kitazato USA, and Donor Application are pioneering leaders that have helped nearly one million families. Headquartered in Los Angeles, Generate operates facilities in Tucson, New York, Boston, Palo Alto, and Rockville, MD. Generate is a portfolio company of GI Partners, a private investment firm based in San Francisco.

About Insception Biosciences Inc.Insception Biosciences Inc. is part of the Cell Care group which comprises Insception Lifebank, Cells for Life, and the Victoria Angel public bank in Canada, and Cell Care in Australia. The combined group is one of the world's top 10 companies in the sector with over 200,000 cord blood and tissue samples stored. The Cell Care group has invested in clinical trials investigating the impact of autologous cord blood in type-1 diabetes, sibling cord blood in cerebral palsy and has supported research into expansion technologies for a number of years. Prior to the acquisition, the Cell Care group was a portfolio company of CPE Capital, a private investment firm based in Sydney, Australia. Visit http://www.insception.com for more information.

Media ContactAzeem ZeekryaHDMZ[emailprotected]312-506-5244

SOURCE Generate Life Sciences

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Insception Lifebank and Cells for Life Join the Generate Life Sciences Family to Create a Global Platform - Canada NewsWire

Caption

By: Peter Marks, M.D., Director, Center for Biologics Evaluation and Research

The U.S. Food and Drug Administration continues to facilitate the development and availability of innovative medical products, such as regenerative medicine therapies, that have the potential to treat or even cure diseases or conditions for which few effective treatment options exist. For example, the agency has recently licensed (approved) its first product that received Regenerative Medicine Advanced Therapy (RMAT) designation, underscoring our ongoing commitment to work with sponsors and manufacturers to bring these products to market.

Unapproved products marketed as regenerative medicine therapies may cause serious harm to patients. Cellular therapies, including stem-cell products, are often marketed by clinics as being safe and effective for the treatment of a wide range of diseases or conditions, even though they havent been adequately or appropriately studied in clinical trials.

In 2017, the FDA issued guidance on the regulatory framework for regenerative medicine therapies and announced its intent to exercise enforcement discretion with respect to the FDAs investigational new drug (IND) and premarket approval requirements for certain regenerative medicine products. This policy gave manufacturers three-and-a-half-years to determine the appropriate regulatory pathway for their products, and if an application is needed, ample time to prepare and submit the appropriate application to the FDA.

Now that we have reached the end of the compliance and enforcement discretion policy period, we are once again reminding manufacturers, clinics, and health care practitioners and providers that the compliance and enforcement discretion policy for certain human cells, tissues, and cellular and tissue-based products (HCT/Ps), including regenerative medicine therapies, ended on May 31, 2021. If manufacturers continue to illegally market unapproved HCT/Ps, they do so at their own risk and may be subject to an enforcement action.

The FDA continues to receive consumer complaints and has warned consumers about unapproved regenerative medicine products and the unfounded claims made in advertisements and direct-to-patient marketing. Despite the FDAs warnings that an IND may be required for these products, many entities still ignore such warnings and offer these unapproved and unproven products, with some consumers subsequently experiencing serious adverse effects.

The compliance and enforcement discretion policy was never intended to excuse the violations of manufacturers or health care providers who are offering unapproved regenerative medicine products that have the potential to put patients at significant risk. The policy did not apply to products that have been associated with reported safety concerns or have the potential to cause significant safety concerns to patients.

Indeed, while the policy was in place, the FDA took swift and aggressive action in the face of serious violations of the law, including some involving patient harm. Since November 2017, the FDA has pursued two enforcement actions for injunction against manufacturers of such violative HCT/Ps.

The FDA prevailed in one of those cases, United States v. US Stem Cell Inc. et al., in June 2019, before the United States District Court for the Southern District of Florida. Earlier this week, the United States Court of Appeals for the Eleventh Circuit affirmed the lower courts judgment. The US Stem Cell decision is a victory for public health and an endorsement of the FDAs work to stop stem cell clinics that place patients at risk by marketing products that violate the law.

The other case for injunction, United States v. Cell Surgical Network et al., is currently being litigated in the United States District Court for the Central District of California. A third enforcement action pursued by the FDA was resolved in March 2018. That case involved the seizure of vials of Vaccinia Virus Vaccine, Live, used to create an unapproved and dangerous stem cell product (a combination of excess amounts of live virus and stromal vascular fraction a stem cell mixture derived from body fat).

The FDA also has taken numerous actions since the compliance and enforcement policy was announced. During this period, the agency issued 14 Warning Letters and 24 Untitled Letters involving violative HCT/Ps regulated under Section 351 of the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act and applicable FDA regulations. Additionally, since December 2018, the FDA has issued 400 letters to manufacturers and health care providers who may be offering violative stem cell or related products since December 2018.

The FDA reminds all stakeholders that the agencys acceptance of an establishment registration and HCT/P listing does not constitute a determination that an establishment is in compliance with applicable rules and regulations or that the HCT/P is licensed or approved by the FDA. It is inappropriate and misleading to advertise establishment registration and product listing in any manner that may imply product approval or compliance with the law.

If manufacturers, clinics, and health care providers offering regenerative medicine products to patients did not contact the FDA about the need for an IND during the period the Tissue Reference Group Rapid Inquiry Program was offered, there remain three options that have been available for many years and these options continue to be available. We want to remind stakeholders that a product that requires but lacks premarket approval may not be lawfully marketed or offered for sale, including when a sponsor has an IND or is pursuing an IND or BLA for its HCT/P.

The FDA is committed to helping advance the development of clinical trials for regenerative medicine products with the shared goal of safe and effective products for patients. We look forward to working with those who share this goal.

For more information: Important Patient and Consumer Information About Regenerative Medicine Therapies

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Innovative Regenerative Medicine Therapies Safety Comes First - FDA.gov

SAN DIEGO, June 1, 2021 /PRNewswire/ --ViaCyte, Inc., a clinical-stage regenerative medicine company focused on developing cell therapies that provide a functional cure for patients with diabetes announced today presentation of a late-breaking ePoster with commentary on behalf of the study by Manasi Sinha Jaiman, M.D., M.P.H., Vice President, Clinical Development, at the upcoming American Diabetes Association's Virtual 81st Scientific Sessionsto be held on June 25-29, 2021.

The ePoster, "Stem Cell-Derived Islet Replacement Therapy (VC-02) Demonstrates Production of C-Peptide in Patients with Type 1 Diabetes (T1D) and Hypoglycemia Unawareness" will be available for conference attendees to view and submit questions on Friday, June 25, 2021, at 11:30 a.m. ET.

"We believe that the data presented at ADA from our stem cell-derived islet replacement therapy program brings us one step closer to delivering a functional cure for type 1 diabetes," said Dr. Jaiman. "Our mission is to re-define the way in which diabetes is managed today by eliminating the burden of constant insulin administration with a therapy designed to deliver physiological regulation of blood glucose, thus enabling better health outcomes for patients."

After the conference, the ePoster will be available at the journal Diabetes website.

About ViaCyte

ViaCyte is a privately held regenerative medicine company developing novel cell replacement therapies based on two major technological advances: cell replacement therapies derived from pluripotent stem cells and medical device systems for cell encapsulation and implantation. ViaCyte has the opportunity to use these technologies to address critical human diseases and disorders that can potentially be treated by replacing lost or malfunctioning cells or proteins. The company's first product candidates are being developed as potential long-term treatments for patients with type 1 diabetes to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications. To accelerate and expand the company's efforts, ViaCyte has established collaborative partnerships with leading companies, including CRISPR Therapeutics and W.L. Gore & Associates. ViaCyte is headquartered in San Diego, California. For more information, please visit http://www.viacyte.com and connect with ViaCyte on Twitter, Facebook, and LinkedIn.

About PEC-Direct (VC-02)

ViaCyte's PEC-Direct (VC-02) product candidate is being developed for treatment of patients with type 1 diabetes who have hypoglycemia unawareness and/or extreme glycemic lability. It is an investigational cell replacement therapy comprised of pancreatic islet progenitor cells in a non-immunoprotective pouch, which allows direct vascularization of the implanted cells. VC-02 is designed to enable production of both insulin and glucagon to modulate blood glucose, improve time in range, and ameliorate or prevent complications associated with type 1 diabetes. Phase 2 clinical studies to evaluate the safety and efficacy of VC-02 are ongoing (clinical trial identifier: NCT03163511).

About the ADA's Scientific Sessions

The American Diabetes Association's (ADA) 81st Scientific Sessions, the world's largest scientific meeting focused on diabetes research, prevention, and care, will be held virtually June 25-29, 2021. Leading physicians, scientists, and health care professionals from around the world will unveil cutting-edge research, treatment recommendations and advances toward a cure for diabetes. Attendees will receive exclusive access to all virtual content for 90-days after the event, with access ending September 29, 2021.For more information, visit https://professional.diabetes.org/scientific-sessions.

SOURCE ViaCyte, Inc.

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ViaCyte to Present Late-Breaking Data at the American Diabetes Association's 81st Scientific Sessions - PRNewswire

Bluebird Bio is tamping down cancer concerns regarding a gene therapy approach to preventthe sickling of blood cells (above).

By Jocelyn KaiserMar. 10, 2021 , 3:00 PM

Gene therapy researchers are breathing easier after a company reported today that the modified virus it used to treat sickle cell disease in a person who later developed leukemia was very unlikely to have caused the cancer.

The leukemia case, which Bluebird Bio disclosed on 16 February, led the company to halt its two sickle cell disease trials and suspend sales of a similar treatment for beta-thalassemia. The following week, the U.S. Food and Drug Administration (FDA) put a hold on the companys two sickle cell disease trials and two beta-thalassemia trials.

But the company has now done various lab tests and found important evidence demonstrating that it is very unlikely our BB305 lentiviral vector played a role in this case, said Chief Scientific Officer Philip Gregory in a press release. The company is now in discussions with FDA about lifting the trial hold.

The studies use a modified virus called a lentivirus to insert a curative gene into the chromosomes of patients blood stem cells. About 2 decades ago, a different viral vector was tested to treat the blood stem cells of patients with an inherited immune disorder, and several later developed leukemia as a result.

This did not happen in the sickle cell trial, Bluebird suggests. The company had reported on 25 February that the patients leukemia cells had mutations and other changes in some known leukemia genes, suggesting these changeswhich are typical in leukemiacontributed to the cancer.

That didnt completely rule out a role for the lentiviral vector, which the company had said earlier inserted its DNA into the patients leukemia cells. But today the company reports that the gene where that DNA landed, VAMP4, plays no known role in cancer. Moreover, the DNA inserted into VAMP4 did not turn on or off any nearby genes, tests showed.

Gene therapy researcher Donald Kohn of the University of California, Los Angeles, agrees with the companys conclusion. There is no evidence that the integrant was affecting expression of any genes near its integration site, says Kohn, who is one of several academic researchers who consulted with Bluebird. That makes the case quite different from the cases years ago. (Bluebird is paying Kohn for his time, but he says that didnt influence his opinion.)

Bluebird had also reported that a different patient had developed a preleukemic condition called myelodysplastic syndrome (MDS). But the company has walked back that concern. It now says the person had some possible signsanemia and an extra chromosome in some bone marrow cellsbut did not turn out to have abnormal bone marrow cells that would indicate MDS.

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Viral vector unlikely to be cause of leukemia in gene therapy patient - Science Magazine