Category Archives: Maryland Stem Cells

SEATTLE--(BUSINESS WIRE)--Today, Pluristyx, panCELLa, and Implant Therapeutics management are excited to announce their corporate merger, pending shareholder approval. The merged company will combine complementary portfolios to offer end-to-end customer support and provide increased access to a wide range of induced pluripotent stem cell (iPSC)-related products and services. The integrated technological and service offerings will greatly accelerate the development and delivery of revolutionary cell therapies to patients.

This merger announcement follows their successful partnership in January 2022 which enables streamlined access to the next generation of safe, universal, cost-effective, off-the-shelf" iPSCs. Pluristyx/panCELLas iPSCs are generated through a proprietary mRNA-based technology and are conveniently available in a try-before-you-buy research evaluation model requiring low up-front licensing fees. Packaged in Pluristyxs Ready-to-Differentiate format, iPSCs containing panCELLas FailSafe and hypoimmunogenic technologies offer customers, at any stage of product development, the ability to rapidly assess and select lines for further development and manufacturing. Since Plurisytx/panCELLa iPSCs are sourced from clinical-grade material, commercial partners can readily transition from development to therapeutic manufacturing.

Regarding this merger, Mahendra Rao, Co-Chairman of the Board at panCELLa and CEO of Implant Therapeutics, commented, We are extremely excited to be joining forces with Pluristyx. From the start of our collaboration, it was clear that the expertise and strong track record in cell therapy development within the Pluristyx team was the perfect fit to maximize the customer benefit from our technologies. By coming together, we can offer clients an industry-leading suite of technologies and services for the next generation of cell therapies.

Benjamin Fryer, Chief Executive Officer, Pluristyx said: In discussions with customers, it became evident that panCELLas hypoimmune and FailSafe technologies are seen as industry gold-standards. This merger takes us one step farther in our journey to become the leading provider of iPSC and cell therapy solutions for research, diagnostic, and clinical applications. Together with the expertise and technology portfolio of panCELLa, we can now provide a full suite of tools and provide the fastest path to gene-edited iPSC-based therapies.

The merged companies will retain the Pluristyx name with panCELLa becoming a wholly owned subsidiary of Pluristyx. Benjamin Fryer will continue as the Chief Executive Officer and Mahendra Rao will take on the role of Chief Science Officer. Current Pluristyx and panCELLa executives will be Jason Carstens as the Chief Operating Officer, Brian Hawkins as the Chief Technology Officer, Kaye Reiter as General Counsel, Jake Krembil as VP of Business Development/Toronto Site Lead, and James Laing as VP of Finance.

About Pluristyx

Pluristyx is a privately held biotechnology company based in Seattle, WA that offers consulting, wet-lab and GMP banking services, and pluripotent stem cell products to support novel therapeutic developers. Pluristyx helps industry and academic researchers solve manufacturing and analytical challenges in cryopreservation, drug development, regenerative medicine, and cell and gene therapy. The Pluristyx team has decades of experience supporting every stage of cell therapy product development, from cell banking to drug product manufacturing including analytical testing and release of clinical grade cell therapy products. To learn more, visit http://www.pluristyx.com or email info@pluristyx.com.

About panCELLa

Co-founded in 2015 by Dr. Andras Nagy, PhD, stem cell biologist and Dr. Armand Keating, MD, PhD, clinical scientist, and hematologist, panCELLa is a privately held early-stage biotechnology firm based on the innovative technology developed in Dr. Andras Nagys lab at the Sinai Health System (SHS) in Toronto, Canada. panCELLa has created platforms that allow for the development of safe, universal, cost-effective, off-the-shelf therapeutic cell products for medicine. panCELLa has secured partnerships with several biotechnology partners to enhance its patent position and provide expanded access to its exclusive FailSafe and Cloaked Cells/iACT cells. panCELLa continues its internal R&D efforts to develop additional novel uses of its platform technologies in areas such as bio-production, cancer vaccination and tolerization. To learn more, visit https://pancella.com.

About Implant Therapeutics

A subsidiary of panCELLa, Implant is a biotechnology company based in Maryland, United States. As a developer of genetically engineered stem cells, Implant combines the advantages of iPSC-MSC with panCELLas exclusive safety platforms to deliver the ultimate therapeutic MSC products. To learn more, visit: http://www.implant-rx.com

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Pluristyx, panCELLa, and Implant Therapeutics Announce Definitive Merger Agreement - Business Wire

Parkinsons disease is a brain condition that causes uncontrollable or unintended movements.

The immune system uses proteins referred to as antibodies to detect and attack invading pathogens. Mini versions of antibodies, called nanobodies natural compounds in the blood of animals such as llamas and sharks are being researched to treat autoimmune diseases and cancer. Now, scientists from Johns Hopkins Medicine have helped create a nanobody that can penetrate the tough outer layer of brain cells and disentangle misshapen proteins that cause disorders such as Parkinsons disease, Lewy body dementia, and other neurocognitive problems.

The structure of alpha-synuclein clumps (on the left) was disrupted by the nanobody PFFNB2 (as shown on the right). Credit: Xiaobo Mao

Researchers from Johns Hopkins Medicine, under the direction of Xiaobo Mao, Ph.D., and researchers from the University of Michigan, Ann Arbor, collaborated on the study, which was recentlypublished in the journal Nature Communications. They set out to discover a new treatment method that could target the misshapenproteins known as alpha-synuclein, which have a tendency to cluster and impede the inner workings of brain cells. New research suggests that alpha-synuclein clumps can spread from the gut or nose to the brain, accelerating disease progression.

Theoretically, antibodies may be able to target clumping alpha-synuclein proteins, but pathogen-fighting compounds have difficulty penetrating the outer covering of brain cells. To get past thetough brain cell coatings, the researchers chose to employ nanobodies, which are tiny versions of antibodies.

Traditionally, nanobodies produced outside of the cell may not perform the same function within the cell. As a result, the researchers had to strengthen the nanobodies in order for them to remain stable inside a brain cell. They achieved this by genetically engineering the nanobodies to purge them of the chemical bonds that normally degrade within a cell. Tests revealed that even without the bonds, the nanobody was still able to bind to misshapenalpha-synuclein and stay stable.

An infographic describing nanobodies. Credit: Ayanna Tucker, Joshua Glenn, and Lauren Hines

The team made seven, similar types of nanobodies, known as PFFNBs, that could bind to alpha-synuclein clumps. Of the nanobodies they created, one PFFNB2 did the best job of glomming onto alpha-synuclein clumps and not single molecules, or monomers of alpha-synuclein. Monomer versions of alpha-synuclein are not harmful and may have important functions in brain cells. The researchers also needed to determine if the PFFNB2 nanobody could remain stable and work inside brain cells. The team found that in live mouse-brain cells and tissue, PFFNB2 was stable and showed a strong affinity to alpha-synuclein clumps rather than single alpha-synuclein monomers.

Additional tests in mice showed that the PFFNB2 nanobody cannot prevent alpha-synuclein from collecting into clumps, but it can disrupt and destabilize the structure of existing clumps.

Strikingly, we induced PFFNB2 expression in the cortex, and it prevented alpha-synuclein clumps from spreading to the mouse brains cortex, the region responsible for cognition, movement, personality, and other high-order processes, says Ramhari Kumbhar, Ph.D., the co-first author, a postdoctoral fellow at the Johns Hopkins University School of Medicine.

The success of PFFNB2 in binding harmful alpha-synuclein clumps in increasingly complex environments indicates that the nanobody could be key to helping scientists study these diseases and eventually develop new treatments, says Mao, associate professor of neurology.

Reference: -Synuclein fibril-specific nanobody reduces prion-like -synuclein spreading in mice by Yemima R. Butler, Yuqing Liu, Ramhari Kumbhar, Peiran Zhao, Kundlik Gadhave, Ning Wang, Yanmei Li, Xiaobo Mao, and Wenjing Wang, 19 July 2022, Nature Communications.DOI: 10.1038/s41467-022-31787-2

The study was funded by the University of Michigan, the National Institutes of Health, the Parkinsons Foundation, and the Maryland Stem Cell Research Foundation.

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Johns Hopkins Scientists Have Developed a Nanobody That May Treat Parkinson's Disease - SciTechDaily

As students at a research intensive institution, many members of the University of Maryland community continued their academic studies and research past the traditional academic year.

From medical studies to artificial intelligence research, students at this university pursued groundbreaking work in summer 2022. Tevin Okutoyi, a senior biology and French major, spent this summer as a member of a National Institutes of Health research program.

Okutoyi was matched with a mentor to study sickle cell anemia, a red blood cell disease that creates a higher risk of clots and blockages. Blockages can limit the amount of blood that reaches the brain, which can cause cognitive issues such as ADHD.

Using analytical software, Okutoyi examined data on children ages 8 to 12 with the sickle cell disease from clinics across the mid-Atlantic. He worked to determine whether cognitive tests for ADHD and other neurodevelopmental disorders could diagnose the same disorders in children with sickle cell anemia.

Though the study showed mixed results, Okutoyi said his research has helpful implications.

This can really impact [childrens] ability to be successful in school, Okutoyi said. If physicians can also use these tests to diagnose those conditions, itll ensure that children in the future will have access to the resources that they need.

This summer at the business schools Center for Health Information and Decision Systems on campus, junior biology and management major Tarun Mattikalli helped with an initiative to improve access to artificial intelligence in health care.

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AI could help doctors view images to diagnose health conditions, Mattikalli said. Before this technology can be implemented, however, researchers must address issues with bias in AI technology.

Mattikalli will continue working with AI this fall, training the technology to make diagnoses using medical images. The research will serve as an aid to radiologists.

A lot of radiologists have a long workflow with images and it takes a lot of time to comb through them, so having that as a tool can be very helpful, Mattikalli said. Theres also a lot of potential if its easy to access, providing hope.

Many Gemstone Honors Program students are closing out their four-year research projects at the beginning of this semester. Among them is senior cell biology and genetics major Katie Brown. She and her research team are gearing up to finish their project that examines how the lining of the intestine heals from damages, such as inflammatory bowel disease.

Were studying recovery time and the way the cells come back to each other, Brown said. That information would then be used by scientists and medical experts down the line to say,What kind of drugs can we use to make this go faster? How can we study this better?

[UMD launches new Shuttle-UM app to mixed student reaction]

For this research, Browns team has been using organoid models artificially grown cells or tissues that resemble an organ made from mouse colon stem cells and grown in a 3D matrix. Their lab experiments emulate the intestines injury and recovery process. Brown and her team contended with COVID-19 their first year, but persevered through online meetings and summer work. This fall, they will reach their final data collection and analysis. In the spring, they will present their final thesis.

Junior public health science and Spanish major Roman Kassaraba is also about to begin the data collection phase of his Gemstone honors project. Kassarabas team is studying perceptions of disordered eating in the male population. Most research into disordered eating skews toward affluent, young, white women, Kassaraba said. Most research on how men perceive eating disorders has been retrospective.

There has been a discrepancy in information and data on a key population, which were hopefully aiming to close that gap with our studies, Kassaraba said.

Kassarabas team will begin surveying young men at this university and collecting data when their research proposal has been approved. The survey will use scaling systems that are already available, but they will include demographic information, such as race, sexual orientation and economic status. Kassaraba said this will allow for a more comprehensive analysis that doesnt let certain groups fall through the cracks.

While it may seem daunting, Mattikalli offered encouraging words to other students who hope to pursue similar undergraduate research opportunities.

I always encourage people to get out there and learn about what theyre excited about. Because its a lot of cool stuff going on, especially in Maryland, Mattikalli said.

Excerpt from:
UMD students contribute to tech, health fields with summer research projects - The Diamondback

Two Johns Hopkins research teams have received technology development grants totaling approximately $200,000 through the Louis B. Thalheimer Fund for Translational Research.

A total of 14 researchers applied for the latest funding round. Finalists pitched their proposals virtually in late May to an outside panel of independent researchers and investors, innovation executives and venture investors.

Established through a $5.4 million gift from businessman and philanthropist Louis B. Thalheimer, the fund provides seed funding for proof-of-concept and validation studies of Johns Hopkins technologies.

Since 2016, the Thalheimer Fund has awarded more than $1.7 million to 20 projects at Johns Hopkins. Grants range from $25,000 to $100,000 and all recipients have formally reported their inventions to Johns Hopkins Technology Ventures (JHTV).

Previous Thalheimer winners are developing a faster and more accurate wayto diagnose epilepsy; an oral therapy for patientssuffering from inflammatory bowel disease; and a longer-lastingtreatment for wrinkles and migraines, among other technologies.

This years grantees are:

Urinfo: Holographic Urine Monitoring to Prevent Catheter-Associated Urinary Tract Infections

Principal investigator:Nicholas J. Durr, assistant professor in the Department of Biomedical Engineering

The pitch:Real-time patient monitoring for early signs of potential infection

Catheter-associated urinary tract infections (CA-UTIs) are the most common hospital-based infections. A significant risk factor is prolonged used of a catheter, and nearly 80% of the 500,000 annual cases are thought to be preventable with timely intervention.

The current approach to managing CA-UTIs is mostly reactive, monitoring for symptoms followed by diagnostic confirmation. Durr and his collaborators have invented a lens-free imaging device that can provide continuous, noninvasive analysis of urine to with the potential to detect early signs of CA-UTI.

A flow chamber sits between the catheter and urine bag that is continually imaged, from which the urines bacterial load is determined through an algorithm. If the load surpasses a predefined threshold or displays a worrisome trend, the clinician is alerted. Flow chambers would be changed for each patient, while the rest of the system would be reusable.

JHTV is pursuing patent protection for the technology. The team has developed a benchtop prototype of the system and part of the Thalheimer funding will go toward developing a bedside prototype. They also will use the grant to collect initial data to prepare a federal Small Business Innovation Research grant application.

Cytoplasmic Transfer Cell Therapy for Vision Repair in Retinitis Pigmentosa

Principal investigator:Mandeep S. Singh,assistant professor of ophthalmology and genetic medicine at the Johns Hopkins Wilmer Eye Institute

The pitch:A novel way to treat multiple inherited retinal diseases at once.

Inherited retinal diseases (IRDs) cause vision loss in approximately one in 4,000 people and are caused by a mutation in any one of about 300 genes expressed in photoreceptor cells of the retina. Gene therapies are in development to treat more than 25 individual IRD gene mutations. But Singh, working with Robert Johnston, Ph.D., an associate professor in the Department of Biology at The Johns Hopkins University, is developing a new treatment modality, cytoplasmic transfer cell (CTC) therapy, that has the potential to treat the majority of IRDs with one off-the-shelf product.

CTC therapy involves generating differentiated photoreceptor cells from human pluripotent stem cells, cells that can be developed into any type of human cell, that are then administered to patients. Early observations suggest CTC treatment may permanently restore vision with just one treatment. The team is initially focusing on treating autosomal recessive retinitis pigmentosa (ARRP), a progressive hereditary disorder which accounts for 35% of IRDs.

JHTV is pursuing patent protection for the technology. Singh is planning to form a startup around the technology and has met potential investors with the help of Sashank Reddy, JHTVs medical director. The Thalheimer funding will go toward hiring staffers to help culture CTC cells and continue testing.

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Pair of Hopkins teams receive $200K in technology grants - Maryland Daily Record

The collaboration draws on RoosterBios cell and media products and process development services, coupled with AGC Biologics cell and gene therapy manufacturing capabilities.

The two companies see 'tremendous opportunities' in EVs/exosomes: with projections suggesting a CAGR of 31% (2015-2030) for the market, reaching the $1bn mark by 2027.

In published biomedical research, this subject area now exceeds monoclonal antibodies and liposomes, note the companies: who draw a comparison to a similar pace of growth for monoclonal antibodies during the 1980s ahead of their boom (with this sector now worth around $100bn in global annual sales).

RoosterBio and AGC Biologics believe these research growth rates indicate this cell type is becoming a popular choice amongst developers to help advance the cell and gene product pipeline.

However, access to exosome cell and media development and manufacturing facilities to get treatments into the clinic is still scarce: with the new partnership seeking to bridge this gap and give cell and gene developers end-to-end services.

In the new partnership, Frederick, Maryland-headquartered RoosterBio will use its portfolio of cell and media products to develop robust, scalable processes for human mesenchymal stem/stromal cells (hMSC) and exosome therapies.

These capabilities include genetic engineering of cells and exosomes to express therapeutic targets, upstream processing in both 2D flask and 3D bioreactor systems, downstream purification to achieve desired purity and potency, and comprehensive analytical characterization of the resulting formulated cell or exosome therapy.

Meanwhile, Seattle-headquartered AGC Biologics will contribute its global network to provide full Process Development, cGMP Manufacturing, Quality Control and Regulatory services for pre-clinical and phase I/II clinical trials, with the ability to scale to Phase III and commercial production.

The CDMO has a global network of sites dedicated to cell therapy technologies and processes, including allogenic and autologous systems and techniques.

More details on this partnership will be released in the coming months.

"RoosterBio has a reliable method for producing engineered cells and exosomes that can help developers create life-saving therapies," said Patricio Massera, Chief Executive Officer of AGC Biologics. "When you combine their work and expertise with AGC Biologics' scientific knowledge and global manufacturing services, it creates a comprehensive offering that can help these developers save time and money, and get their treatments in the hands of patients in need."

Tim Kelly, Chief Executive Officer of RoosterBio, said: Biopharmaceutical companies striving to develop engineered cell and exosome therapies require proven, flexible technologies paired with reliable and scalable manufacturing solutions. This collaboration was conceived to deliver that end-to-end solution for our customers and I am thrilled to partner with AGC Biologics to translate our hMSC and exosome technologies into advanced therapy products that have the potential to bring curative treatments to patients in need.

Excerpt from:
RoosterBio and AGC Biologics team up to accelerate manufacture of cell and exosome therapies - BioPharma-Reporter.com

At a Glance

Sickle cell disease is an inherited blood disorder that affects more than 90,000 Americans, mostly of African descent. The condition arises from a genetic defect that alters the structure of hemoglobin, the oxygen-carrying protein found in red blood cells. The modified hemoglobin causes normally round red blood cells to become stiff, sticky, and sickle-shaped. The deformed cells can block blood flow, causing severe pain, organ damage, and stroke.

There is no widely available cure for sickle cell disease. Some children with the disease have been successfully treated with blood stem cell, or bone marrow, transplants. This approach, though, was thought to be too toxic for use in adults. High doses of chemotherapy are used to destroy all of a childs bone marrow, which is then replaced with marrow from a donor. Stem cell recipients typically need to take immunosuppressants for months to a few years. These medications can cause serious side effects.

In earlier studies, transplant recipients were found to have a mix of their own and the donors cells in their blood. Despite the mix, sickle cell disease was reversed. Based in part on these findings in children, as well as other preliminary work, a team at NIHs Clinical Center in Bethesda, Maryland, set out to test a modified transplant procedure in adults with sickle cell disease. The clinical trial was conducted by researchers from NIHs National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and National Heart, Lung, and Blood Institute (NHLBI). Results appeared online on July 1, 2014, in the Journal of the American Medical Association.

Thirty patients, ages 16 to 65, with severe sickle cell disease enrolled in the study between 2004 and 2013. The patients first underwent a less toxic regimen to kill off some of their marrow cells. They then underwent a stem cell transplant, receiving cells donated by a healthy brother or sister.

The team found that the stem cell transplant reversed the disease in 26 of 30 patients (87%). The patients had normal hemoglobin, fewer hospitalizations, and lower use of narcotics to treat pain from the disease. The patients didnt experience graft-versus-host diseasein which donor cells attack the recipientafter a median follow up of 3.4 years. Fifteen patients successfully stopped immunosuppression medications a year after the transplant. The treatment was unsuccessful in 4 patients, and some complications, such as infections, occurred.

Side effects caused by immunosuppressants can endanger patients already weakened by years of organ damage from sickle cell disease, says senior author Dr. John Tisdale. Not having to permanently rely on this medication, along with use of the relatively less-toxic partial stem cell transplant, means that even older patients and those with severe sickle cell disease may be able to reverse their condition.

The researchers continue to follow the patients to track the success of the approach. People with sickle cell disease interested in joining NIH blood stem-cell transplant studies may call 1-800-411-1222 or visit the NIH clinical trials registry at https://clinicaltrials.gov for more information.

Funding:NIHs National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and National Heart, Lung, and Blood Institute (NHLBI).

Original post:
Stem Cell Transplant Reverses Sickle Cell Disease in Adults

In this document, the terms "Longeveron," "Company," "we," "us," and "our" referto Longeveron Inc. We have no subsidiaries.

This Quarterly Report on Form 10-Q (this "10-Q") contains forward-lookingstatements, within the meaning of the Private Securities Litigation Reform Actof 1995, that reflect our current expectations about our future results,performance, prospects and opportunities. This 10-Q contains forward-lookingstatements that can involve substantial risks and uncertainties. All statementsother than statements of historical facts contained in this report, includingstatements regarding our future results of operations and financial position,business strategy, prospective products, product approvals, research anddevelopment costs, future revenue, timing and likelihood of success, plans andobjectives of management for future operations, future results of anticipatedproducts and prospects, plans and objectives of management are forward-lookingstatements. These statements involve known and unknown risks, uncertainties andother important factors that may cause our actual results, performance orachievements to be materially different from any future results, performance orachievements expressed or implied by the forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as"anticipate," "believe," "contemplate," "continue," "could," "estimate,""expect," "intend," "may," "plan," "potential," "predict," "project," "should,""target," "will," or "would" or the negative of these terms or other similarexpressions, although not all forward-looking statements contain these words.Factors that could cause actual results to differ materially from thoseexpressed or implied in any forward-looking statements contained in this reportinclude, but are not limited to, statements about:

The forward-looking statements contained in this 10-Q are made on the basis ofthe views and assumptions of management regarding future events and businessperformance as of the date this 10-Q is filed with the Securities and ExchangeCommission (the "SEC"). In addition, we operate in a highly competitive andrapidly changing environment; therefore, new risk factors can arise, and it isnot possible for management to predict all such risk factors, nor to assess theimpact of all such risk factors on our business or the extent to which anyindividual risk factor, or combination of risk factors, may cause results todiffer materially from those contained in any forward-looking statement. We donot undertake any obligation to update these statements to reflect events orcircumstances occurring after the date this 10-Q is filed. In addition, thisdiscussion and analysis should be read in conjunction with our unauditedfinancial statements and notes thereto included in this 10-Q and the auditedfinancial statements and notes thereto included in our Annual Report on Form10-K for the year ended December 31, 2021, filed with the SEC on March 11, 2022("2021 10-K"). Operating results are not necessarily indicative of results thatmay occur in future periods.

Overview and Recent Developments

We are a clinical stage biotechnology company developing cellular therapies forspecific aging-related and life-threatening conditions. Our lead investigationalproduct is the LOMECEL-B cell-based therapy product ("Lomecel-B"), which isderived from culture-expanded medicinal signaling cells (MSCs) that are sourcedfrom bone marrow of young healthy adult donors. We believe that by using thesame cells that promote tissue repair, organ maintenance, and immune systemfunction, we can develop safe and effective therapies for some of the mostdifficult disorders associated with the aging process and other conditions.

We are currently sponsoring or have sponsored Phase 1 and 2 clinical trials inthe following indications: Aging Frailty, Alzheimer's disease (AD), theMetabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplasticleft heart syndrome (HLHS). Our mission is to advance Lomecel-B and othercell-based product candidates into pivotal Phase 3 trials, with the goal ofachieving regulatory approvals, subsequent commercialization and broad use bythe healthcare community.

Our philosophy is that healthy aging can be improved through regenerativemedicine approaches. Life expectancy has substantially increased over the pastcentury as a result of medical and public health advancements. However, thisincrease in longevity has not been paralleled by the number of years a person isexpected to live in relatively good health, with limited chronic disease anddisabilities of aging - a period known as healthspan. As we age, we experience:a decline in our own stem cells; a decrease in immune system function, known asimmunosenescence; diminished blood vessel functioning; chronic inflammation,known as "inflammaging"; and other aging-related declines. Our preliminaryclinical data suggest that Lomecel-B can potentially address these problemsthrough multiple mechanisms of action, or MOAs, that simultaneously target keyaging-related processes.

Improving healthspan is an imperative for governmental health agencies. TheNational Institute on Aging (NIA), an institute of the National Institutes ofHealth (NIH), has promoted the concept of geroscience - the idea that agingitself is the biggest risk factor for aging-related human diseases and thataging can be approached as a treatable disease to improve healthspan. Thegeroscience hypothesis provides a strong rationale for the approach of treatingunderlying biological processes contributing to aging as a way to reduce diseaseburden and advance global human health. Our investments into developing andtesting product candidates are aimed at reducing aging-related disease burdenand improving healthspan.

Our core business strategy is to become a world leading regenerative medicinecompany through the development and commercialization of novel cell therapyproducts for unmet medical needs, with emphasis on aging-related indications.Key elements of our business strategy are as follows.

? Advance Lomecel-B and other regenerative medicine products to market. We are

advancing Lomecel-B into later stage clinical trials for the purpose of

achieving commercialization in one or more indications. Our studies throughout

the clinical development process are intended to generate safety and efficacy

data needed to advance these programs, and establish foundations for subsequent

development and expansion into new areas. We will continue to leverage our

technical and clinical expertise, and relationships with clinical

investigators, treatment centers, and other key stakeholders, to explore new

? Expand our manufacturing capabilities to commercial-scale production. We

operate a good manufacturing practice (GMP) - compliant manufacturing facility

and produce our own product candidates for testing. We continue to improve and

expand our capabilities with the goal of achieving cost-effective manufacturing

that may potentially satisfy future commercial demand should Lomecel-B achieve

? Non-dilutive funding. Our clinical programs have received over $16.0 million in

competitive extramural grant awards ($11.9 million which has been directly

awarded to us and which are recognized as revenue when the performance

obligations are met) from the NIH, Alzheimer's Association, and Maryland Stem

Cell Research Fund (MSCRF). These prestigious funding awards are non-dilutive

and allow us to collaborate with state and federal partners in pursuing safe

and effective therapeutics for disorders that have few, if any, available

? Continue to develop our existing international programs. We have selected Japan

as our first non-U.S. territory for a randomized, double-blinded,

placebo-controlled clinical trial to evaluate Lomecel-B for Aging Frailty. We

may explore other indications in Japan, and potentially pursue Aging Frailty

and other indications in additional international locations for further

development and commercialization.

? Collaboration arrangements and out-licensing opportunities. We will be

opportunistic and consider entering into co-development, out-licensing,

commercialization or other collaboration agreements for the purpose of

commercializing Lomecel-B and other products domestically and internationally.

? Product candidate development pipeline through internal research and

development, and in-licensing. Through our research and development program,

and through strategic in-licensing agreements, or other business development

arrangements, we continue to actively explore promising potential additions to

our pipeline of product candidates.

? Continue to expand our intellectual property portfolio. Our intellectual

property is vitally important to our business strategy, and we take significant

steps to develop this property and protect its value. Results from our ongoing

research and development efforts are intended to add to our existing

intellectual property portfolio.

We continue to monitor how the COVID-19 pandemic is affecting our employees,business, and clinical trials. During the initial stages associated with thespread of COVID-19, we instructed all employees who could perform theiressential employment duties from home to do so. Our laboratory scientists, cellprocessing scientists and other manufacturing personnel continued to work fromour GMP facility and headquarters on a day-to-day basis, and as such cellproduction has been minimally impacted. When the pandemic began to emerge in theU.S., most of our ongoing clinical trials had completed enrollment. However, afew subjects that were currently on study and in follow-up experienced somedifficulties in adhering to the protocol schedule. Because we primarily enrollelderly subjects in our trials, who are at particular risk for poor outcomesrelated to COVID-19 infection, we experienced some disruption in executing thefollow-up visits in our protocols. These disruptions were due to a number ofreasons that include an unwillingness of the subject to leave their residence tovisit the hospital or clinic, the inability to leave their residence due toregional "stay-at-home" orders, and temporary clinical site closures. We haveattempted to mitigate this disruption by conducting remote visits where feasible(telemedicine), arranging for in-home visits for phlebotomy in order to collectblood samples and perform protocol-specific assessments if feasible, andamending protocols to increase the window of time for follow-up visits. In spiteof these efforts, several subjects either missed their scheduled follow upvisit, had their follow up visit outside of the protocol-defined window of time,or dropped out of the trial prior to completing. While we believe the number ofinstances where a visit was missed completely is small, we cannot predictwhether this will have a material impact on our clinical results until the datafrom the trials are analyzed. If too many subjects drop-out or the protocol isno longer effective, we may have to restart the clinical trial entirely.

In July 2020 the Bahamian government halted travel from the U.S. into TheBahamas, which resulted in the temporary cessation of participation in TheBahamas Registry Trial. While this travel restriction has now been lifted,participation in the Registry Trial remains lower than anticipated, due in partto pandemic-related effects on international travel.

Presently, several Longeveron employees continue to work from home either fulltime, or through a hybrid schedule, and we anticipate that this will continuefor the foreseeable future. We expect that the COVID-19 pandemic may continue toimpact our business, results of operations, clinical development timelines andfinancial condition. At this time, there is significant uncertainty relating tothe trajectory of the COVID-19 pandemic and impact of related responses. Theimpact of COVID-19 on our future results will largely depend on futuredevelopments, which are highly uncertain and cannot be predicted withconfidence, such as the ultimate geographic concentration and continued spreadof the disease, the duration of the pandemic, travel restrictions to and socialdistancing within the United States and other countries, business closures orbusiness disruptions, the continued impact on financial markets and the globaleconomy, and the effectiveness of the global response to contain and treat thedisease.

Lomecel-B for Alzheimer's Disease:

? In January 2022, we initiated enrollment of a 48-patient, 4-arm, parallel

design, randomized (1:1:1:1) Phase 2a clinical trial of Lomecel-B infusion in

patients with mild Alzheimer's disease. This study is intended to evaluate the

safety of single and multiple administrations of Lomecel-B compared to placebo

according to the following treatment groups:

o Group 1 (n=12): Placebo infusion (zero cells) on day 0, weeks 4, 8 and 12

o Group 2 (n=12): Lomecel-B infusion (25 million cells) on day 0, followed by

placebo infusions at Weeks 4, 8 and 12

o Group 3 (n=12): Lomecel-B infusion (25 million cells) on day 0, weeks 4, 8, and

12

o Group 4 (n=12): Lomecel-B infusion (100 million cells) on day 0, weeks 4, 8,

and 12

? Other endpoints in the Phase 2a trial include brain volumetry by MRI,

biomarkers relevant to inflammation and endothelial/vascular systems, and

measures of cognitive function. We currently plan to activate up to 12 clinical

sites to facilitate enrollment, and intend to provide updates on anticipated

enrollment rates as additional sites are activated, as well as trial completion

guidance at a later date. Further details about the trial design can be found

on clinicaltrials.gov by entering trial identifier NCT05233774.

? On March 31, 2022, we announced the publication of a manuscript in Alzheimer's

& Dementia: The Journal of the Alzheimer's Association detailing the

previously completed and announced Phase 1 Alzheimer's disease trial results.

Lomecel-B for Hypoplastic Left Heart Syndrome (HLHS):

? The ELPIS II trial (Phase 2a) continues to enroll infants in the 38-patient,

2-arm, parallel design, randomized (1:1), blinded controlled trial intended to

evaluate the safety and efficacy of Lomecel-B injection into the right

ventricle of children born with HLHS who are undergoing Stage II reconstructive

cardiac surgery. All seven planned clinical sites have now been activated for

screening and enrollment and additional sites are being considered.

? We anticipate that a manuscript detailing the full Phase 1 ("ELPIS I") trial

results (the top-line data having been previously announced on September 9,

2021), to be submitted to a peer-reviewed journal, with acceptance and

publication currently anticipated in 2022.

Lomecel-B for Aging Frailty:

? The planned Japanese Aging Frailty Phase 2 trial is currently on track to

initiate in the first half of 2022. This is an investigator-initiated 3-arm,

parallel design, randomized (1:1:1), placebo-controlled, double-blind single

infusion study of two different dose levels of Lomecel-B being conducted by our

clinical partners at the National Center for Geriatrics & Gerontology (NCGG;

Nagoya), and Juntendo University Hospital (Tokyo).

? Top-line results from the Phase 1/2 "HERA" Aging Frailty trial are currently

expected to be disclosed in the first half of 2022. The HERA Trial is a small

multicenter, randomized, placebo-controlled study intended primarily to

evaluate safety, and to explore the effect Lomecel-B may have on specific

biomarkers of immune system function in older individuals with mild to moderate

Aging Frailty who received the high dose influenza vaccine, as well as evaluate

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LONGEVERON INC. Management's Discussion and Analysis of Financial Condition and Results of Operations. (form 10-Q) - Marketscreener.com

Are you feeling run down and exhausted? Do you find yourself struggling to get through the day without a nap? If so, you may need to rejuvenate your body. There are many ways to do this, and this blog post will discuss some of the best methods. It will also talk about how improving your overall well-being can help improve your energy levels and mood. So if youre ready to feel like your old self again, keep reading.

One of the best ways to rejuvenate your body is to consider different types of therapy. This could include things like massages, acupuncture, or even yoga. These therapies can help to relax your muscles and improve your circulation. They can also help to reduce stress levels, which can be a big contributor to fatigue. Massages, in particular, can be very beneficial for improving energy levels. Acupuncture is another great option for those looking to rejuvenate their bodies. This ancient therapy has been used for centuries to help improve overall health. It involves the insertion of thin needles into specific points on the body. This can help to improve circulation and reduce stress levels.

On the other hand, yoga can be a great way to improve flexibility, strength, and stamina. It can also help to clear your mind and reduce stress. You can also consider stem cell therapy, but make sure that you consult with a qualified professional first. This type of therapy can be very beneficial because it can help to repair and regenerate damaged cells. It can also help to improve your overall health and well-being. If youre not sure what type of therapy would be best for you, consider talking to your doctor or a health professional.

Another great way to rejuvenate your body is to eat a healthy diet. This means eating plenty of fruits, vegetables, and whole grains. It also means avoiding processed foods, sugary drinks, and excessive amounts of caffeine. Eating a healthy diet can improve your energy levels, mood, and overall health. It can also help to reduce stress levels and improve your sleep quality. If youre not sure where to start, there are plenty of resources available online and in books. You can also talk to a nutritionist or dietitian for more specific advice.

Exercising regularly is another great way to rejuvenate your body. This is because it can help to improve your circulation, increase your energy levels, and reduce stress. Some of the best exercises for this include walking, running and swimming. However, its important to find an exercise that you enjoy and can stick with. Otherwise, you may not see the benefits. If you need some motivation to get started, consider signing up for a class or hiring a personal trainer. This way, youll be more likely to stick with it.

One of the most important things you can do for your body is to get enough sleep. Most adults need around eight hours of sleep per night. However, many people only get six or seven hours. This can lead to fatigue and other health problems. If youre having trouble sleeping, there are a few things you can try. First, make sure that your bedroom is dark and quiet. This will allow you to relax and fall asleep more easily. Second, avoid using electronics in bed. Finally, establish a regular sleep schedule and stick to it as much as possible.

Finally, strive to make changes in your lifestyle. This means things like reducing stress, quitting smoking, and getting regular exercise. These changes can be difficult to make, but theyre worth it in the long run. Not only will you feel better, but youll also be more likely to stick with them. If you need help making these changes, consider talking to your doctor or a counselor. They will be able to guide you in the right direction. Just make sure that youre ready to commit before you get started.

There are many different ways to rejuvenate your body. However, these are some of the best methods. If youre feeling run down and exhausted, consider trying one or more of these methods. You may find that you have more energy and feel better overall. Improving your well-being can also help to improve your energy levels and mood. So if youre ready to feel like your old self again, start by making some changes to your lifestyle. Rest assured that these simple changes can make a big difference in how you feel.

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Top Ways To Rejuvenate Your Body And Improve Your Well-being - The Southern Maryland Chronicle

SUNNYVALE, Calif., April 12, 2022 (GLOBE NEWSWIRE) -- BioCardia, Inc.[Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug (IND) application for BCDA-04, a proprietary allogeneic mesenchymal cell (MSC) population that is Neurokinin-1 receptor positive (NK1R+). This allows BioCardia to initiate its First-in-Human Phase I/II trial in adult patients recovering from Acute Respiratory Distress Syndrome (ARDS) due to COVID-19, with trial initiation expected in the third quarter of 2022.

The first part of the clinical trial will evaluate increasing doses of the NK1R+ MSCs and the optimal dose will be taken to Phase II in a randomized study in adult patients recovering from ARDS due to COVID-19. "This investigational cell therapy is administered intravenously (IV) and follows a significant body of compelling clinical results by NIH investigators and peer companies," said Ian McNiece, Ph.D., BioCardias Chief Scientific Officer. "After IV delivery, the cells migrate to the lungs for local therapeutic benefit. We expect the anti-inflammatory nature of these mesenchymal stem cells to have a positive impact in ARDS because of the interaction of the Neurokinin-1 receptors with Substance P, a neuropeptide that has long been known to be a primary mediator of inflammation in the lungs. Our goal is to help recovering patients with ARDS due to COVID-19 recover faster and more fully, while avoiding longer term respiratory issues."

"In addition to our critically important autologous cell therapies being studied for ischemic heart failure and chronic myocardial ischemia with refractory angina, the FDA's acceptance of this IND for patients recovering from ARDS is an important milestone in the development of our allogeneic mesenchymal stem cell therapy platform and validation for its potential to provide therapeutic benefit beyond the cardiovascular system," said Peter Altman, Ph.D., Chief Executive Officer. "Our off the shelf MSC platform may have significant advantages over others in clinical development for multiple indications because the MSCs express the biologically important NK1 receptor which binds Substance P. Our in-house clinical cell manufacturing is also expected to be an important strategic asset that enables rapid and cost-effective development."

About ARDS

Acute respiratory distress syndrome (ARDS) occurs when fluid builds up in the tiny, elastic air sacs (alveoli) in the lungs. The fluid keeps the lungs from filling with enough air, which means less oxygen reaches the bloodstream. This deprives organs of the oxygen they need to function. ARDS typically occurs in people who are already critically ill or who have significant injuries. Severe shortness of breath the main symptom of ARDS usually develops within a few hours to a few days after the precipitating injury or infection. Many people who develop ARDS don't survive. The risk of death increases with age and severity of illness. Of the people who do survive ARDS, some recover completely while others experience lasting damage to their lungs1. Based on preliminary clinical reports on COVID-19, respiratory failure complicated by ARDs is the leading cause of death for COVID-19 patients.2 Despite multiple clinical studies, no pharmacological treatments have proven effective for ARDS.3, 4

About BioCardia

BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP autologous and NK1R+ allogeneic cell therapies are the Companys biotherapeutic platforms that enable four product candidates in clinical development. The CardiAMP Cell Therapy Heart Failure Trial investigational product has been granted Breakthrough designation by the FDA, has CMS reimbursement, and is supported financially by the Maryland Stem Cell Research Fund. The CardiAMP Chronic Myocardial Ischemia Trial also has CMS reimbursement. For more information visit:www.BioCardia.com.

FORWARD LOOKING STATEMENTS

This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, initiation of our BCDA-04 clinical trial, and the mechanism of action and ease of administration of our NK1R+ MSC therapy.

We may use terms such as believes, estimates, anticipates, expects, plans, intends, may, could, might, will, should, approximately or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardias Form 10-K filed with the Securities and Exchange Commission on March 29, 2022, under the caption titled Risk Factors. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

_________________________________________________________________________________________________________

Media Contact:Anne Laluc, MarketingEmail:alaluc@BioCardia.comPhone: 650-226-0120

Investor Contact:David McClung, Chief Financial OfficerEmail:dmcclung@BioCardia.comPhone: 650-226-0120

(1)MayoClinic.Org

(2)Rajagopal K, Keller SP, Akkanti B, et al. Advanced pulmonary and cardiac support of COVID-19 patients, emerging recommendations from ASAIOa living working document. Circ Heart Fail. 2020 May;13(5).

(3)Thompson BT, Chambers RC, Liu KD (2017) Acute respiratory distress syndrome. N Engl J Med 377(19):19041905.

(4)3. Group RC, Horby P, Lim WS et al (2020) Dexamethasone in hospitalized patients with Covid-19preliminary report. N Engl J Med.

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BioCardia Announces FDA Approval of Its IND for NK1R+ Mesenchymal Stem Cells for the Treatment of Patients Recovering from Acute Respiratory Distress...

A woman whose body keeps rejecting her fetus after a few months of pregnancy. A man who, certain at 18 that he needs a vasectomy, suddenly finds in his late 40s that he wants children, but his vasectomy reversal fails. Thus opens The Genesis Machine, with the stories of its two authors.

Its an enticing opening to a fascinating book by quantitative futurist Amy Webb and microbiologist Andrew Hessel, but also a bit of a red herring. Hessel and his wife solved their problem through in vitro fertilization, Webb and her husband theirs through genetic testing and ovulation induction agents. Neither author needed synthetic biology, the field that has sprung up around CRISPR, the DNA-editing machine.

The Genesis Machine

Nevertheless, Webb and Hessel skilfully detail the history, endless possibilities and many upsides of synthetic biology. Via in vitro gametogenesis, same-sex couples will soon be able to have babies bearing their own genetic material, without requiring donors. Wheat DNA has already been edited to produce more fibre, tomatoes to require less water and sunlight. Using stem cells, biologists are already developing protein that is, at a molecular level, actual beef. No cows necessary. No cattle blowing their greenhouse gases into the atmosphere.

Synthetic biology has recently had signal success in Modernas development of mRNA COVID-19 vaccines. Despite anti-vaxxer conspiracy theories, these vaccines are even less dangerous than conventional vaccines.

When the pandemic first hit, Dr. Zhang Yongzhens team in Shanghai decoded the COVID-19 genome in 40 hours and, thankfully, published it to GenBank shortly thereafter, paving the road to several vaccines. Nowadays you can buy a sequencing machine for the price of an iPhone. Pharmaceutical companies are developing mRNA vaccines for malaria and other diseases. At the same time, university researchers are working on editing the genetic structure of the mouths of malaria-carrying mosquitos to make them incapable of biting and, thus, of laying their eggs.

Supplied photo

Authors Amy Webb and Andrew Hessel

Other advances, such as plastic trees whose leaves sequester far more C02 than real trees do, may be far less beneficial than claimed, because Webb and Hessel ignore the exorbitant cost of materials and production.

Older stories of synthetic insulin lead into the contemporary adventures of synthetic biology entrepreneur Craig Venter. Particularly interesting is the account of He Jiankui who, without getting Chinese governmental permission, edited a pair of human twin embryos (hoping to make them immune to AIDS), leading to live births. In 2019, he was sentenced to three years in prison.

Mark Teske / The Associated Press files

Members of the surgical team perform the transplant of a pig heart into patient David Bennett in Baltimore, MD in January 2022. Bennett died in early March.

Despite how the authors baby quests rig the deck emotionally in favour of synthetic biology, the late-arriving Nine Risks chapter offers readers a choice of nightmares. Worried about deepfakes worming their way into the public record and falsifying it? How about augmented viruses leaving the lab and worming their way into your body?

Or how about a near future in which the Haves all have enough genetic enhancements to make the Have-nots nostalgic for their present poverty? Upgrade your children before birth! Certainly, it makes sense to edit out sickle-cell anemia, but it would take a very self-controlled genie not to agree to splice superior looks, athletic ability and intelligence into a customers childrens DNA. Chinas BGI group is already touting IQ boosts.

The EU and a number of countries have legislated against germline engineering, but that was before CRISPR, and that number doesnt include the synthetic biology leaders: China and the U.S. Harvards George Church, who wants to create a mostly woolly mammoth by splicing preserved mammoth DNA with Asian elephants, has also declared an interest in splicing Neanderthal DNA into contemporary humans, and perhaps cloning a Neanderthal. But we really have no idea what will happen when genetically engineered organisms outcross with other organisms in the wild, also known as the world.

Towards the end of The Genesis Machine, Webb and Hessel present some futuristic scenarios: for example, the pamphlet Creating Your Child with Wellspring. Such flourishes might work well for business visioning retreats, but the results in print are weak. Webb and Hessel would be better off staying with the science and leaving fictionalizations of synthetic biology to Richard Powers Generosity (2009) or Margaret Atwoods MaddAddam trilogy (2003-13).

Too recent to have made it into The Genesis Machine is the attempt at the University of Maryland Medical Center to implant a gene-edited pig heart into a human, but Webb and Hessel do mention that Chinese scientists are developing super-pigs that are more virus-resistant, stronger and quicker to mature than the present models. Are we closing in on Atwoods 2003 fictional pigoons pigs spliced with human neocortical tissue?

Life is becoming programmable, say Webb and Hessel. Imagine a synthetic biology app store

Reinhold Kramer is a Brandon University English professor. His most recent book is Are We Postmodern Yet? And Were We Ever?

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Synthetic biology's past, present and future explored in timely new account - Winnipeg Free Press