BOSTON and MIAMI, Oct. 1, 2020 /PRNewswire/ -- Aegle Therapeutics Corporation today announced theU.S. Food and Drug Administration(FDA) has granted Fast Track designation to AGLE-102 for the treatment of patients with dystrophic epidermolysis bullosa ("DEB"), a rare genetic pediatric skin blistering disorder. AGLE-102 is an extracellular vesicle ("EV") therapy that delivers proteins, genetic material and regenerative healing factors to diseased and damaged tissue. AGLE-102 will be evaluated in DEB patients in a phase 1/2a trial initiating in 2021.

The Fast Track program is intended to facilitate the development and review of drug candidates that treat serious conditions and fill an unmet medical need. A drug candidate with Fast Track designation is eligible for greater access to the FDA for the purpose of expediting the drug product candidate's development, review and potential approval.

"We are pleased to have received Fast Track designation for AGLE-102. Aegle's EV therapy is unique in that it delivers collagen 7 protein, COL7A1 mRNA and regenerative healing factors to potentially address the complex nature of DEB," said Evangelos Badiavas, MD, PhD, Chief Scientific Officer atAegle Therapeutics. "This designation will expedite the development and regulatory review of AGLE-102 and highlights the importance of providing novel treatments to this patient population."

AboutAegle Therapeutics Corporation

Aegle Therapeutics (www.aegletherapeutics.com) is a privately held biotechnology company developing extracellular vesicles, including exosomes, secreted by mesenchymal stem cells as therapy for the treatment of dystrophic epidermolysis bullosa and other severe dermatological conditions. Aegle anticipates entering the clinic with AGLE-102 in early 2021.

ContactAegle Therapeutics CorporationShelley A. HartmanChief Executive Officer[emailprotected]

SOURCE Aegle Therapeutics Corporation

http://www.aegletherapeutics.com

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FDA Grants Fast Track Status to Aegle Therapeutics' AGLE-102 for the Treatment of Dystrophic Epidermolysis Bullosa - PRNewswire

Engineers at the University of California, Davis, will lead a consortium of universities, biomedical startups and nonprofit organizations to develop interventions for spinal cord injuries that can be applied within days of injury to improve long-term outcomes.

Karen Moxon, professor of biomedical engineering at UC Davis, will lead the five-year, $36 million contract as part of the Defense Advanced Research Project Agency, or DARPA, Bridging the Gap Plus Program. A primary goal is to develop technologies to stabilize a patients hemodynamic response, which includes blood flow and blood pressure, within days of injury.

Because large swings in blood pressure are common following spinal cord injuries, stabilizing hemodynamics within days of injury will improve functional recovery. The team will take advantage of stabilized hemodynamics to optimize delivery of neural stem cells using personalized 3D printed scaffolds within two weeks of injury to regenerate lost connections within the injured spinal cord.

Spinal cord injury is a complex condition that causes partial or complete loss of function below the location of injury, Moxon said. We will develop systems for real-time biomarker monitoring and intervention to stabilize and rebuild neural communications pathways between the brain and spinal cord. As a result of our efforts, clinicians will be able to collect previously unavailable diagnostic information for automated or clinician-directed interventions. Our goal is to translate these technologies to humans within the five-year award period.

The international team includes 12 institutions: UC Davis, UC San Diego, UC San Francisco, the University of British Columbia, the University of Calgary and the cole Polytechnique Fdrale de Lausanne (EPFL, Switzerland); biotech startups Pathonix Innovation Inc. of Vancouver, GTX Medical (Lausanne, Switzerland), and Teliatry (Richardson, Texas); nonprofit institutions the Wyss Center for Bio and Neuroengineering (Geneva, Switzerland) and Battelle Memorial Institute (Columbus, Ohio); and a regulatory consultant firm, NetValue BioConsulting Inc., Toronto.

Moxon and her team at UC Davis including Zhaodan Kong, associate professor in the Department of Mechanical and Aerospace Engineering, and Professor Kiarash Shahlaie and Assistant Professor Julius Ebinu, neurosurgeons in the UC Davis School of Medicine will take the lead on assessing the impact of these interventions on the brain to maximize the restoration of both motor and sensory functions. This part of the project will be conducted at the California National Primate Research Center.

We are extremely pleased that the California National Primate Research Center will host the nonhuman primate research arm of this extraordinary effort to restore function following spinal cord injury, said center director John Morrison, professor of neurology at UC Davis.

Part of the effort will also aim to improve functional recovery, using neural stem cell and bioengineering scaffold technology developed by professors Mark Tuszynski, Paul Lu, Ephron Rosenzweig and Jacob Koffler, all faculty in the Department of Neurosciences at UCSD. Their stem cell and scaffold technology will be combined with neural electrical stimulation technology (neuromodulation) developed by Gregoire Courtine at EPFL. The team hopes to successfully combine this cell and engineering technology to promote nerve regeneration that bridges the injury site.

Moxons lab at UC Davis, in collaboration with a teamat the Wyss Center for Bio and Neuroengineering led by Tracy Laabs, will develop cortical stimulation protocols to enhance sensory feedback to the brain and aid in motor control. The team will take advantage of Wysss ABILITYsystem that wirelessly records signals from individual neurons in the brain and will further develop it to include closed-loop cortical stimulation, which employs a sensor to record signals, for improved motor function.

The multi-institution team will focus on advancing three main technologies:

Together, these technologies will integrate into a system-of-systems that monitors the information from sensors and stimulators to allow clinicians to monitor patients progress. At the same time, the team will be able to identify the optimal time to transplant the neural stem cells and 3D scaffold in this critical time period after injury.

It is exciting to lead this talented team of international scientists and to be in a position to effect real change for people who sustain a spinal cord injury, Moxon said. Its this type of team science between academia and industry that makes clinical breakthroughs possible in short time periods.

Development of the proposal for the award was facilitated by the UC Davis Office of Researchs Interdisciplinary Research Support team and Gabriela Lee, project manager. This project is part of a larger effort at UC Davis led by Moxon, Professor Sanjay Joshi in the Department of Mechanical and Aerospace Engineering, and Professor Carolynn Patten in the School of Medicine and College of Biological Sciences to develop a neuroengineering program that aims to restore, augment and extend human capacity to benefit society.

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UC Davis Engineers Lead $36M Effort to Improve Recovery From Spinal Cord Injuries - UC Davis

Olivia Allen-Price [00:01:55] OK, so what exactly does this bond fund?

Danielle Venton [00:01:59] This would fund $5.5 billion in stem cell research and treatments in California. Some of the diseases that stem cell research is seeking to cure or treat include cancer, Alzheimer's disease, diabetes, spinal cord injuries, blindness, and even COVID-19. I spoke recently with a guy named Jake Javier. He supports this bond initiative because he knows firsthand how life changing stem cell research can be.

Jake Javier [00:02:25] I am in my last year at Cal Poly.

Danielle Venton [00:02:28] So, Jake grew up locally in Danville and was just graduating high school when he suffered a life altering injury.

Jake Javier [00:02:35] On the last day of high school, I drove in to a pool and hit my head on the bottom and broke my neck and was immediately paralyzed.

Danielle Venton [00:02:47] He says his injury was complete, with very little hope of recovery. But a doctor at Stanford reached out to Jake and his family and said, you can be part of this clinical trial where we, with a one time surgery, will inject stem cells into the damaged area and you may possibly see some benefits.

Danielle Venton [00:03:07] Now, Jake is still injured.

Jake Javier [00:03:09] I'm a quadriplegic. I use a wheelchair.

Danielle Venton [00:03:11] But he says after the surgery, he noticed more movement in his arms, in his hands.

Jake Javier [00:03:17] So, I mean, with my injury, I'm at a level where I would normally not have any function at all in my hands and very, very little function like in my triceps and things like that. Muscles that are really important for functionality and, you know, being able to get through day to day activities that could help me push myself around more, help me transfer in and out of my chair independently. And then also, I notice, you know, I got some some finger movement. It doesn't seem like much, but even that little movement has helped me so much with picking things up and things like that. So it was really, I was really blessed to see that happen.

Danielle Venton [00:03:51] So he doesn't know how much of his recovery is due to the stem cells. How much is natural, or how much is due to physical therapy. But today he's able to live independently, to go to college and he wants to pursue a career in medicine. And he is a big believer in stem cell research, regenerative medicine, and is really hoping that California voters will support this proposition.

Olivia Allen-Price [00:04:20] Now, what exactly are stem cells and how do they work, I guess?

Danielle Venton [00:04:25] Yeah, stem cells are types of cells that can be turned into any type of specialized cell. Scientists have known about them since the eighteen hundreds, but it wasn't until the late 90s that researchers developed a method to derive them from human embryos and grow them in a laboratory. And then people really began to get excited about their potential for medicine. Now these cells came from unused embryos created for in vitro fertilization, and they were donated with informed consent. But many anti-abortion groups felt that using the cells were tantamount to taking a human life. So in 2001, then President George W. Bush banned federal funding for any research using newly created stem cell lines.

Olivia Allen-Price [00:05:09] OK. And how does that get us now to bonds in California?

Danielle Venton [00:05:13] Well, Californians wanted to circumvent these federal restrictions, and in 2004 voted for a bond that gave the state $3 billion to create a research agency called the California Institute of Regenerative Medicine, or CIRM. There was a lot of public support for it. And it just felt like these wonderful cures could be right around the corner. Celebrities like Michael J. Fox appeared in TV commercials.

Michael J. Fox TV commercial [00:05:36] My most important role lately is as an advocate for patients, and for finding new cures for diseases. That's why I'm asking you to vote yes on Proposition 71, Stem Cell Research Initiative.

Danielle Venton [00:05:48] And the money for that research, that $3 billion, has now run out. And to continue their work, the stem cell advocacy group, Americans for Cures, is asking voters for more money.

Olivia Allen-Price [00:06:00] So we're basically voting on whether we want to refill the stem cell research piggy bank here.

Danielle Venton [00:06:05] Yeah, exactly. Some question if the state can afford this at this time when budgets are going to be so tight. Others have been disappointed by the slow pace of cures coming out of the field. Now, there are people who credit this research, such as Jake, with improving or restoring their health or the health of their loved ones. Or maybe they hope that one day it will, and they would balk at the idea that this is not worthy research. They point to achievements that the agency has funded. That includes effectively a cure for bubble baby disease. This is when someone is born without a functioning immune system. That mutation can now be corrected with genetically modified stem cells. And recently, just within the last year or so, the FDA approved two new treatments for blood cancer, developed with CIRM support. These achievements are what the agency points to when they're criticized for not having accomplished more. And they say the process of scientific discovery is long and unpredictable.

Olivia Allen-Price [00:07:04] Now, wasn't that Bush-era ban on stem cell research that you were talking about earlier wasn't that overturned?

Danielle Venton [00:07:11] Yes, that was overturned by President Obama. However, there are current members of Congress who are lobbying President Trump to ban the research again. And if that happens, then California would be the only major player in stemcell research once again in the United States.

Olivia Allen-Price [00:07:30] All right, so who is supporting Prop 14?

Danielle Venton [00:07:32] Governor Gavin Newsom, for one. Many patient advocacy organizations and medical and research institutions, including the California Board of Regents. These people don't want to see the pace of this research slow. They want it to accelerate. The political action committee supporting this proposition is reporting more than six million dollars in contributions.

Olivia Allen-Price [00:07:53] All right. And what about the opposition? Who's against it?

Danielle Venton [00:07:55] Well, so far, there's no organized, funded opposition. There have been several newspaper editorials coming out against it, including locally, the Mercury News and the Santa Rosa Press Democrat. They basically say state bonds aren't the way to fund research and the situation isn't like it was in 2004 and that the institute should now seek other sources of funding and move forward as a nonprofit.

Olivia Allen-Price [00:08:19] All right, Danielle. Well, thanks, as always for your help.

Danielle Venton [00:08:21] My pleasure. Thanks.

Olivia Allen-Price [00:08:28] In a nutshell, a vote yes on Proposition 14 says you think Californians should give $5.5 billion to the state's stem cell research institute. That money will be raised by selling bonds, which the state would pay back, with interest, out ofthe general fund over the next 30 years. A vote no means you think we shouldn't spend public money on this research.

Olivia Allen-Price [00:08:54] That's it on Proposition 14. We'll be back tomorrow with an episode on Prop 15. And oh, it is a doozy. Commercial property tax! A partial rollback of one of California's most controversial propositions! It's going to be fire. In the meantime, you can find more of KQED election coverage at KQED.org/elections. Two reminders on the way out: October 19th is the last day to register to vote and mail in ballots must be postmarked on or before November 3rd.

Olivia Allen-Price [00:09:28] Bay Curious is made in San Francisco at member supported KQED. I'm Olivia Allen-Price. See you tomorrow.

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What You Need to Know About Prop 14, The Stem Cell Research Bond (Transcript) - KQED

Researchers from Critical Analytics for Manufacturing Personalized-Medicine (CAMP), an interdisciplinary research group at Singapore-MIT Alliance for Research and Technology (SMART), MITs research enterprise in Singapore, have been awarded Intra-CREATE grants from the National Research Foundation (NRF) Singapore to help support research on retinal biometrics for glaucoma progression and neural cell implantation therapy for spinal cord injuries. The grants are part of the NRFs initiative to bring together researchers from Campus for Research Excellence And Technological Enterprise (CREATE) partner institutions, in order to achieve greater impact from collaborative research efforts.

SMART CAMP was formed in 2019 to focus on ways to produce living cells as medicine delivered to humans to treat a range of illnesses and medical conditions, including tissue degenerative diseases, cancer, and autoimmune disorders.

Singapores well-established biopharmaceutical ecosystem brings with it a thriving research ecosystem that is supported by skilled talents and strong manufacturing capabilities. We are excited to collaborate with our partners in Singapore, bringing together an interdisciplinary group of experts from MIT and Singapore, for new research areas at SMART. In addition to our existing research on our three flagship projects, we hope to develop breakthroughs in manufacturing other cell therapy platforms that will enable better medical treatments and outcomes for society, says Krystyn Van Vliet, co-lead principal investigator at SMART CAMP, professor of materials science and engineering, and associate provost at MIT.

Understanding glaucoma progression for better-targeted treatments

Hosted by SMART CAMP, the first research project, Retinal Analytics via Machine learning aiding Physics (RAMP), brings together an interdisciplinary group of ophthalmologists, data scientists, and optical scientists from SMART, Singapore Eye Research Institute (SERI), Agency for Science, Technology and Research (A*STAR), Duke-NUS Medical School, MIT, and National University of Singapore (NUS). The team will seek to establish first principles-founded and statistically confident models of glaucoma progression in patients. Through retinal biomechanics, the models will enable rapid and reliable forecast of the rate and trajectory of glaucoma progression, leading to better-targeted treatments.

Glaucoma, an eye condition often caused by stress-induced damage over time at the optic nerve head, accounts for 5.1 million of the estimated 38 million blind in the world and 40 percent of blindness in Singapore. Currently, health practitioners face challenges forecasting glaucoma progression and its treatment strategies due to the lack of research and technology that accurately establish the relationship between its properties, such as the elasticity of the retina and optic nerve heads, blood flow, intraocular pressure and, ultimately, damage to the optic nerve head.

The research is co-led by George Barbastathis, principal investigator at SMART CAMP and professor of mechanical engineering at MIT, and Aung Tin, executive director at SERI and professor at the Department of Ophthalmology at NUS. The team includes CAMP principal investigators Nicholas Fang, also a professor of mechanical engineering at MIT; Lisa Tucker-Kellogg, assistant professor with the Cancer and Stem Biology program at Duke-NUS; and Hanry Yu, professor of physiology with the Yong Loo Lin School of Medicine, NUS and CAMPs co-lead principal investigator.

We look forward to leveraging the ideas fostered in SMART CAMP to build data analytics and optical imaging capabilities for this pressing medical challenge of glaucoma prediction, says Barbastathis.

Cell transplantation to treat irreparable spinal cord injury

Engineering Scaffold-Mediated Neural Cell Therapy for Spinal Cord Injury Treatment (ScaNCellS), the second research project, gathers an interdisciplinary group of engineers, cell biologists, and clinician scientists from SMART, Nanyang Technological University (NTU), NUS, IMCB A*STAR, A*STAR, French National Centre for Scientific Research (CNRS), the University of Cambridge, and MIT. The team will seek to design a combined scaffold and neural cell implantation therapy for spinal cord injury treatment that is safe, efficacious, and reproducible, paving the way forward for similar neural cell therapies for other neurological disorders. The project, an intersection of engineering and health, will achieve its goals through an enhanced biological understanding of the regeneration process of nerve tissue and optimized engineering methods to prepare cells and biomaterials for treatment.

Spinal cord injury (SCI), affecting between 250,000 and 500,000 people yearly, is expected to incur higher societal costs as compared to other common conditions such as dementia, multiple sclerosis, and cerebral palsy. SCI can lead to temporary or permanent changes in spinal cord function, including numbness or paralysis. Currently, even with the best possible treatment, the injury generally results in some incurable impairment.

The research is co-led by Chew Sing Yian, principal investigator at SMART CAMP and associate professor of the School of Chemical and Biomedical Engineering and Lee Kong Chian School of Medicine at NTU, and Laurent David, professor at University of Lyon (France) and leader of the Polymers for Life Sciences group at CNRS Polymer Engineering Laboratory. The team includes CAMP principal investigators Ai Ye from Singapore University of Technology and Design; Jongyoon Han and Zhao Xuanhe, both professors at MIT; as well as Shi-Yan Ng and Jonathan Loh from Institute of Molecular and Cell Biology, A*STAR.

Chew says, Our earlier SMART and NTU scientific collaborations on progenitor cells in the central nervous system are now being extended to cell therapy translation. This helps us address SCI in a new way, and connect to the methods of quality analysis for cells developed in SMART CAMP.

Cell therapy, one of the fastest-growing areas of research, will provide patients with access to more options that will prevent and treat illnesses, some of which are currently incurable. Glaucoma and spinal cord injuries affect many. Our research will seek to plug current gaps and deliver valuable impact to cell therapy research and medical treatments for both conditions. With a good foundation to work on, we will be able to pave the way for future exciting research for further breakthroughs that will benefit the health-care industry and society, says Hanry Yu, co-lead principal investigator at SMART CAMP, professor of physiology with the Yong Loo Lin School of Medicine, NUS, and group leader of the Institute of Bioengineering and Nanotechnology at A*STAR.

The grants for both projects will commence on Oct. 1, with RAMP expected to run until Sept. 30, 2022, and ScaNCellS expected to run until Sept. 30, 2023.

SMART was. established by the MIT in partnership with the NRF in 2007. SMART is the first entity in the CREATE developed by NRF. SMART serves as an intellectual and innovation hub for research interactions between MIT and Singapore, undertaking cutting-edge research projects in areas of interest to both Singapore and MIT. SMART currently comprises an Innovation Centre and five interdisciplinary research groups (IRGs): Antimicrobial Resistance, CAMP, Disruptive and Sustainable Technologies for Agricultural Precision, Future Urban Mobility, and Low Energy Electronic Systems.

CAMP is a SMART IRG launched in June 2019. It focuses on better ways to produce living cells as medicine, or cellular therapies, to provide more patients access to promising and approved therapies. The investigators at CAMP address two key bottlenecks facing the production of a range of potential cell therapies: critical quality attributes (CQA) and process analytic technologies (PAT). Leveraging deep collaborations within Singapore and MIT in the United States, CAMP invents and demonstrates CQA/PAT capabilities from stem to immune cells. Its work addresses ailments ranging from cancer to tissue degeneration, targeting adherent and suspended cells, with and without genetic engineering.

CAMP is the R&D core of a comprehensive national effort on cell therapy manufacturing in Singapore.

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SMART researchers receive Intra-CREATE grant for personalized medicine and cell therapy - MIT News

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New microelectrode-array chips for measuring nerve impulses could reveal how thousands of nerve cells interact with each other.

For over 15 years, ETH Zurich professor Andreas Hierlemann and his group have been developing microelectrode-array chips that can precisely excite nerve cells in cell cultures and to measure electrical cell activity. These developments make it possible to grow nerve cells in cell-culture dishes and use chips at the bottom of the dish to examine each individual cell in a connected nerve tissue in detail.

Alternative methods for conducting such measurements have some clear limitations. They are either very time-consumingbecause contact to each cell has to be individually establishedor they require the use of fluorescent dyes, which influence the behavior of the cells and so the outcome of the experiments.

Now, researchers from Hierlemanns group at the department of biosystems science and engineering of ETH Zurich in Basel, together with Urs Frey and his colleagues from the ETH spin-off MaxWell Biosystems, developed a new generation of microelectrode-array chips. These chips enable detailed recordings of considerably more electrodes than previous systems, which opens up new applications.

As with previous chip generations, the new chips have around 20,000 microelectrodes in an area measuring 2 by 4 millimeters. To ensure that these electrodes pick up the relatively weak nerve impulses, the signals need to be amplified. Examples of weak signals that the scientists want to detect include those of nerve cells derived from human pluripotent stem cells (iPS cells). These are currently used in many cell-culture disease models. Another reason to significantly amplify the signals is if the researchers want to track nerve impulses in axons (fine, very thin fibrous extensions of a nerve cell).

However, high-performance amplification electronics take up space, which is why the previous chip was able to simultaneously amplify and read out signals from only 1,000 of the 20,000 electrodes. Although the 1,000 electrodes could be arbitrarily selected, they had to be determined prior to every measurement. This meant that it was possible to make detailed recordings over only a fraction of the chip area during a measurement.

In the new chip, the amplifiers are smaller, permitting the signals of all 20,000 electrodes to be amplified and measured at the same time. However, the smaller amplifiers have higher noise levels. So, to make sure they capture even the weakest nerve impulses, the researchers included some of the larger and more powerful amplifiers into the new chips and employ a nifty trick: they use these powerful amplifiers to identify the points in time at which nerve impulses occur in the cell culture dish. At these time points, they then can search for signals on the other electrodes, and by taking the average of several successive signals, they can reduce the background noise. This procedure yields a clear image of the signal activity over the entire area being measured.

In first experiments, which the researchers report in Nature Communications, they demonstrated their method on human iPS-derived neuronal cells as well as on brain sections, retina pieces, cardiac cells, and neuronal spheroids.

With the new chip, the scientists can produce electrical images of not only the cells but also the extension of their axons, and they can determine how fast a nerve impulse is transmitted to the farthest reaches of the axons.

The previous generations of microelectrode array chips let us measure up to 50 nerve cells. With the new chip, we can perform detailed measurements of more than 1,000 cells in a culture all at once, Hierlemann says.

Such comprehensive measurements are suitable for testing the effects of drugs, meaning that scientists can now conduct research and experiments with human cell cultures instead of relying on lab animals. The technology then also helps to reduce the number of animal experiments.

MaxWell Biosystems is marketing the existing microelectrode technology, which university and industry research groups around the world are using.

Source: ETH Zurich

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Measuring chips amplify and record nerve cells - Futurity: Research News

Newswise For over 15 years, ETH Professor Andreas Hierlemann and his group have been developing microelectrode-array chips that can be used to precisely excite nerve cells in cell cultures and to measure electrical cell activity. These developments make it possible to grow nerve cells in cell-culture dishes and use chips located at the bottom of the dish to examine each individual cell in a connected nerve tissue in detail. Alternative methods for conducting such measurements have some clear limitations. They are either very time-consuming - because contact to each cell has to be individually established - or they require the use of fluorescent dyes, which influence the behaviour of the cells and hence the outcome of the experiments.

Now, researchers from Hierlemann's group at the Department of Biosystems Science and Engineering of ETH Zurich in Basel, together with Urs Frey and his colleagues from the ETH spin-off MaxWell Biosystems, developed a new generation of microelectrode-array chips. These chips enable detailed recordings of considerably more electrodes than previous systems, which opens up new applications.

Stronger signal required

As with previous chip generations, the new chips have around 20,000 microelectrodes in an area measuring 2 by 4 millimetres. To ensure that these electrodes pick up the relatively weak nerve impulses, the signals need to be amplified. Examples of weak signals that the scientists want to detect include those of nerve cells, derived from human pluripotent stem cells (iPS cells). These are currently used in many cell-culture disease models. Another reason to significantly amplify the signals is if the researchers want to track nerve impulses in axons (fine, very thin fibrous extensions of a nerve cell).

However, high-performance amplification electronics take up space, which is why the previous chip was able to simultaneously amplify and read out signals from only 1,000 of the 20,000 electrodes. Although the 1,000 electrodes could be arbitrarily selected, they had to be determined prior to every measurement. This meant that it was possible to make detailed recordings over only a fraction of the chip area during a measurement.

Background noise reduced

In the new chip, the amplifiers are smaller, permitting the signals of all 20,000 electrodes to be amplified and measured at the same time. However, the smaller amplifiers have higher noise levels. So, to make sure they capture even the weakest nerve impulses, the researchers included some of the larger and more powerful amplifiers into the new chips and employ a nifty trick: they use these powerful amplifiers to identify the time points, at which nerve impulses occur in the cell culture dish. At these time points, they then can search for signals on the other electrodes, and by taking the average of several successive signals, they can reduce the background noise. This procedure yields a clear image of the signal activity over the entire area being measured.

In first experiments, which the researchers published in the journalNature Communications, they demonstrated their method on human iPS-derived neuronal cells as well as on brain sections, retina pieces, cardiac cells and neuronal spheroids.

Application in drug development

With the new chip, the scientists can produce electrical images of not only the cells but also the extension of their axons, and they can determine how fast a nerve impulse is transmitted to the farthest reaches of the axons. "The previous generations of microelectrode array chips let us measure up to 50 nerve cells. With the new chip, we can perform detailed measurements of more than 1,000 cells in a culture all at once," Hierlemann says.

Such comprehensive measurements are suitable for testing the effects of drugs, meaning that scientists can now conduct research and experiments with human cell cultures instead of relying on lab animals. The technology thus also helps to reduce the number of animal experiments.

The ETH spin-off MaxWell Biosystems is already marketing the existing microelectrode technology, which is now in use around the world by over a hundred research groups at universities and in industry. At present, the company is looking into a potential commercialisation of the new chip.

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Recording thousands of nerve cell impulses at high resolution - Newswise

In 2004, after President George W. Bush cut off all federal funding for embryonic stem-cell research on religious grounds, Californians strongly backed Proposition 71, a $3-billion bond measure to fund this kind of research, even though such funding is usually not the purview of states.

Supporters of the proposition including this editorial board believed it would allow California to stand out as a leader in this field, advance a budding avenue of research that might save lives and alleviate suffering, bolster its biotech sector and fund possible blockbuster treatments that might earn the state royalties as well. Embryonic stem cells are particularly valuable to research because they are undifferentiated, meaning they do not have a particular function, and researchers could conceivably turn them into specialized cells in order to regenerate human cells and tissue.

In the years since, Proposition 71 gave rise to a burst of scientific discovery. Two cancer treatments it helped fund, for blood and bone-marrow cancers, have been approved by the FDA, though neither of those employed embryonic stem cells and could have been funded even under Bush administration rules. It has also supported promising advances in the treatment of diabetes, bubble boy immune deficiency and vision-robbing retinitis pigmentosa, but other efforts have fallen short in clinical trials.

Moreover, the money helped build laboratories and other infrastructure that give California a head start on research and development, making the state the it place for stem-cell research. Researchers in the state moved to the head of the pack for private grants, because projects are less likely to need the time and money to create facilities before work can begin.

Now that Proposition 71 funding has practically run out, the issue is back on the November ballot with Proposition 14, which seeks nearly double the amount worth of bonds $5.5 billion to continue the juggernaut.

This time, voters should reject the measure, with the caveat that the issue could be reconsidered in a couple of years, if its proponents bring it back in better-designed and more modest form and if there are more successes in human trials and financial payback.

We have long had reservations about how the California Institute for Regenerative Medicine, established as a result of Proposition 71, was set up. Though funded publicly, it is not overseen by the governor and Legislature like other state agencies, and its governing board is too large, at 29 members. Those members generally have ties to the advocacy organizations and research institutions that have received most of the money.

The driving force behind the initiative has been Robert N. Klein II, a Bay Area lawyer and real estate investor. There is no doubting Kleins sincerity in his cause. He knows too well the suffering inflicted by intractable diseases; his son Jordan died of complications of Type I diabetes in 2016. His accomplishment in persuading the state to invest billions in a specific avenue of biomedical research has been exceptional.

However, Klein developed these initiatives largely behind closed doors with little to no public input; he has strong ideas about how things should be run on the stem-cell front and has steadfastly resisted more government oversight. Thats fine when hes investing his own money; its a fatal flaw when he is asking voters for nearly $8 billion, the estimated cost of paying off the bonds over time, according to the Legislative Analysts Office.

Kleins role and the bloated structure of CIRMs super-sized governing board have given rise to some serious ethical mishaps, including a board member who improperly intervened to try to get funding for his organization. (He is no longer on the board.) After this and several other examples of impropriety, rules were tightened. Board members must recuse themselves from votes when there is a conflict of interest, but with 29 members who all want certain projects to receive funding, there is too much potential for mutual back-scratching. Instead of repairing this problem, the new proposition would expand CIRMs board to 35 members and retain its troubling independence from oversight by the governor and Legislature, leaving it open to further conflicts of interest.

Proposition 71 hasnt yet yielded a significant financial return on investment for the state or the cures that were ballyhooed at the time. Though no one ever promised quick medical miracles, campaign ads strongly implied they were around the corner if only the funding came through. Proponents oversold the initiatives and voters cant be blamed if they view this new proposal with skepticism.

In the years since Proposition 71 passed, more resources have become available. President Obama reversed Bushs order and restored federal funding, which meant that between CIRM and the National Institutes of Health, along with private grant and investment funding, stem-cell research has been healthy, if not downright flush. That funding has stayed and even grown under President Trump, to more than $2 billion a year, with about $321 million of that in human embryonic stem-cell research. (There have, though, been recent threats to embryonic research from a group of conservative senators.)

The idea was never for California to become the long-term replacement for federal funding. It was to kick-start an industry that would then operate on its own. If that has failed to happen under Proposition 71 as promised, it shouldnt be the responsibility of California taxpayers to fix it. Thats especially true right now, at a time of yawning needs to address the cost of twin health and economic crises and the worsening effects of climate change. Private money for stem cell-work will continue to be available; its not as though research will collapse.

No doubt, the pace of responsible science is incremental and the outcomes uncertain even with the best research efforts. Yet the backers still couch the possibilities in grandiose terms. In a recent interview with the Times editorial board, Klein talked about the money that would be saved by wiping out Alzheimers disease which has so far has frustrated attempts to treat it effectively, despite many billions of dollars in research.

Embryonic stem cell research remains important, and there might be ways in which the state can contribute less grandiose funding while maximizing its investment. For example, scientific research has a well-known valley of death, where many projects cant get funding to make the transition from laboratory to human clinical trials.

Offering some matching help to get projects through that phase might attract businesses and scientists to California, while spending far less than the billions proposed in Proposition 14. Its worth noting that stem-cell work isnt the only kind of research that faces the valley of death problem; its an issue for most basic research that seeks to make the leap to human trials and that might be equally in need of state help.

Now is not the time for a huge new investment in specialized medical research. First, it makes sense to wait until after the election; if Democrats do well, there should be growing support for embryonic stem-cell research at the federal level, which is where such funding should take place. The future of Californias pandemic-battered economy and budget remains to be seen. Waiting also would give voters a chance to find out how well the states stem-cell research projects continue without state dollars, and whether some of the promising advances lead to breakthrough therapies and a return on Californias investment.

There would be an opportunity to rethink and rewrite any future proposals, which should include a far more modest ask of taxpayers as well as fixes to the structure and inflated size of the CIRM board. The institute should also be placed under the same state oversight as other agencies reporting to the governor.

If CIRM needs money for a basic operating budget over the next couple of years, that could be covered by the states general fund. The agency still needs to administer already-funded projects and could use that time to discuss a more affordable path forward. Right now, the state has other, more urgent spending priorities.

Editors note: This newspapers owner, the physician and scientist Dr. Patrick Soon-Shiong, played no role in the editorial boards deliberations on this measure.

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No on Prop 14: Not the best way to support stem-cell research - Los Angeles Times

Asymmetrex discusses new advances for supply of traditional drug development and advanced therapy medicinal product (ATMP) clinical trials

BOSTON (PRWEB) October 01, 2020

Adapting to the present COVID crisis, this year the 2020 Outsourcing in Clinical Trials USA Conference, one of several international clinical trials supply trade conferences organized by Arena International Events Group each year, adopted a virtual meeting format. The conference, scheduled for September 30-October 1, continued its tradition of bringing together contract research organization suppliers and company sponsors in the clinical trials supply industry to discuss new developments and best practices.

Among the many industry members invited to speak in the event, James L. Sherley, M.D., Ph.D., founder and director of Massachusetts stem cell biotechnology company Asymmetrex, presented on September 30. Dr. Sherleys presentation highlighted a growing new area of the clinical trials supply industry. More and more, the clinical trials supply industry is considering better technology and practices to support stem cell clinical trials and gene therapy clinical trials that utilize advanced therapy medicinal products. In particular, Dr. Sherley discussed the value of implementing new quantification technologies for ATMPs developed with tissue stem cells. He answered the rhetorical question that was the title of his talk How can we outsource stem cell clinical trials without counting tissue stem cells? by detailing places in ATMP supply chains where instituting counting technologies would provide significant benefits to the stem-gene clinical trials supply industry and the patients it serves.

Sherley also presented innovation proposals for traditional pharmaceutical and biopharmaceutical clinical trials supply. He described how tissue stem cell counting technologies represented advantages both for discovery of novel drugs and for toxicology evaluations of new drug candidates. A major value presented was the opportunity for drug companies to realize hundreds of millions of dollars in reduced costs each year by using tissue stem cell counting tests for earlier identification of drugs that would fail late in clinical trials because of inducing chronic failure of organs and tissues like the liver and bone marrow. Currently applied animal toxicology studies miss many drugs with this disastrous character. Sherley described how such drugs could be detected in inexpensive cell culture tests by counting how stem cell-specific number and viability changed in their presence.

Though not a main focus of the presentation, Sherley ended his presentation with acknowledgement of Asymmetrexs recent introduction of the first-in-kind technology for counting therapeutic tissue stem cells and determining their dosage. The company holds issued patents for the technology and its use for drug evaluations in both the U.S. and U.K. In August of this year, it published a peer-reviewed report, co-authored with its partner AlphaSTAR Corporation, that describes the new method and its applications for stem cell therapy and drug evaluations. In September, the company was awarded a research and development grant from the National Institutes of Health-National Heart, Lung, and Blood Institute for continued development of the technology and its commercialization. These plans for the companys AlphaSTEM Test tissue stem cell counting technology were recently reported.

About Asymmetrex

Asymmetrex, LLC is a Massachusetts life sciences company with a focus on developing technologies to advance stem cell medicine. The companys U.S. and U.K. patent portfolio contains biotechnologies that solve the two main technical problems production and quantification that have stood in the way of effective use of human adult tissue stem cells for regenerative medicine and drug development. Asymmetrex markets the first technology for determination of the dose and quality of tissue stem cell preparations (the AlphaSTEM Test) for use in stem cell transplantation therapies and pre-clinical drug evaluations. Asymmetrex is a member company of the Advanced Regenerative Manufacturing Institute BioFabUSA and the Massachusetts Biotechnology Council.

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Asymmetrex Presents the Value of Tissue Stem Cell Counting For Supplying Stem Cell Clinical Trials and Drug Development Clinical Trials - PR Web

HOUSTON, Oct. 1, 2020 /PRNewswire/ -- FibroGenesis, the leading developer of fibroblast based therapeutic solutions for unmet medical needs has entered into a clinical collaboration agreement with Brazilian R4D Biotech.Holding the world's largest patent portfolio in the field of cell therapies using fibroblasts, FibroGenesis is expanding its ongoing clinical programs internationally. The partnership will pave the way for clinical studies of PneumoBlast in Brazil as a unique treatment of acute respiratory distress syndrome (ARDS) for patients affected by COVID-19, in parallel to clinical studies in the United States upon approval by the FDA.

Administration of PneumoBlast in pre-clinical and animal studies resulted in dramatic improvement of immunological signaling molecules, reducing concentrations of the inflammatory cytokines interleukin-1 beta, interleukin-6, interleukin-8, interleukin-17, interleukin-18, and Tumor Necrosis Factor alpha TNFa. Company scientists have also demonstrated that PneumoBlast has induced statistically significant reduction of lung fibrosis and lung scarring in COVID-19 infected animals, particularly when compared to more conventional treatments using bone marrow derived mesenchymal stem cells (BMSCs). Furthermore, recent data supports the potential benefits of PneumoBlast for preventing COVID-19 blood clotting. Both companies will collaborate on a clinical study design that meets the needs of Brazilian patients.

"As the scientific and medical community is discovering more about the biological and medical consequences of the COVID-19 infection, FibroGenesis is eager to contribute to the therapeutic cure options currently being created to fight this global war against this virus," commented Pete O'Heeron, Chief Executive Officer, FibroGenesis. "The collaboration with R4D Biotech is another strategic milestone that emphasizes our commitment to expand fibroblast research globally."

"The lab results which indicate our cell therapy approach possesses both therapeutic effects on animal models of the acute stage of COVID-19, and also benefits a cure for residual pathology seen in COVID-19 patients, has our research team extremely excited," said Thomas Ichim, Ph.D., Chief Scientific Officer, FibroGenesis.

"Technology transfer is at the core of this partnership," said Paulo Ferraz, BRICS/Emerging Markets Director of international fund Newstar Ventures and an advisor for FibroGenesis on this transaction. "R4D Biotech has access to sophisticated resources comprising research facilities and hospitals, and its talent pool includes scientific advisors who are recognized academics and distinguished members of the Brazilian Academy of Pharmaceutical Sciences. PneumoBlast clinical study will represent the first step in a long-term relationship designed to aid in the discovery of advanced therapeutic solutions for chronic medical needs."

About R4D Biotech:R4D Biotech is a Brazilian emerging company headquartered in the state of So Paulo focused on research and development for biotechnology and healthcare, with the mission of bringing disruptive technology innovation across all steps of clinical development in life sciences.

About FibroGenesis:Based in Houston, Texas, FibroGenesis is a regenerative medicine company developing an innovative solution for chronic disease treatment using human dermal fibroblasts. Currently, FibroGenesis holds 240+ U.S. and international issued patents/patents pending across a variety of clinical pathways, including Disc Degeneration, Multiple Sclerosis, Parkinson's, Chronic Traumatic Encephalopathy, Cancer, Diabetes, Liver Failure, Colitis and Heart Failure. FibroGenesis represents the next generation of medical advancement in cell therapy.Visit http://www.Fibro-Genesis.com.

SOURCE FibroGenesis

http://www.Fibro-Genesis.com

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FibroGenesis Expands Fight Against COVID-19 In Brazil with International Collaboration - PRNewswire

MADISON,WI(September 30, 2020) From bone marrow transplants to discoveries about skin cancer to human stem cells, UWMadison has fostered many of the developments that shaped modern medicine. And Robert Golden, dean of the School of Medicine and Public Health, is certain that the UW will be home to the developments that shape the future of medicine, too.

The UW is perfectly positioned to build further on our traditions of excellence, he says, because our collaborative environment creates synergies across the domains of basic science, clinical, and translational research, bringing new discoveries from the bench to the bedside and ultimately into communities.

Golden hosted a conversation on the future of medicine as part of the Wisconsin Medicine livestream series on September 29. His guests included Dhanansayan Shanmuganayagam, director of the UWs Biomedical and Genomic Research Group; David Gamm, director of the McPherson Eye Research Institute; and Petros Anagnostopoulos, chief of the pediatric cardiothoracic surgery section at American Family Childrens Hospital. Each of the doctors described new developments in their area.

Organ transplantation is one of the greatest advances in modern medicine, but the need for organs for transplantation is far greater than the available donor organs, said Shanmuganayagam. He noted that more than 109,000 Americans are currently waiting for an organ transplant, and every 20 minutes one of them dies for lack of a donor. How do we plan to solve this crisis? We believe the answer is something called xenotransplantation: the transplant of organs from one species to another.

Shanmuganayagam then described how his group has learned to genetically engineer pigs even engineering a new breed, the Wisconsin Miniature Swine to grow organs that may eventually be transplanted to patients.

Gamm has been involved in using human stem cells to address vision loss and blindness. He believes that stem cells may help address or even reverse diseases of the retina, such as macular degeneration and retinitis pigmentosa.

We are looking for ways we can use the cells that we grow in the laboratory dish not just as model systems, he says, but actually to replace those cells that have died in the course of a disease, to act sort of as spare parts for the retina and so potentially restore vision.

Anagnostopoulos discussed the expertise of UW surgeons in treating cardiac conditions, particularly among children. For the patient complexity that we see, and the breadth of surgery that we see, our outcomes are statistically superior than they should be expected to be, he said

After the three doctors presented, Golden brought forward questions from some of the hundreds of viewers who watched the event live on YouTube. To hear more from Golden and the members of the panel,view a recording of Wisconsin Medicine. This was the fourth installment in the series, which ran through September.

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Wisconsin Medicine Livestream: The future of medicine - Wisbusiness.com

NEW YORK, Oct. 2, 2020 /PRNewswire/ --BrainStorm-Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, announced today that the Company will hold a conference call to update shareholders on financial results for the third quarter ended September 30, 2020, and provide a corporate update, at 8:00 a.m., Eastern Daylight Time (EDT), on October 15, 2020.

BrainStorm's CEO, Chaim Lebovits, will present a corporate update, after which, participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, President and Chief Medical Officer, David Setboun, PharmD, MBA, Executive Vice President and Chief Operating Officer, and Preetam Shah, PhD, MBA, Executive Vice President and Chief Financial Officer.

Participants are encouraged to submit their questions prior to the call by sending them to:q@brainstorm-cell.com. Questions should be submitted by5:00 p.m. EDT,Tuesday, October 13, 2020.

Teleconference Details BRAINSTORM CELL THERAPEUTICS 3Q 2020

The investment community may participate in the conference call by dialing the following numbers:

Participant Numbers:

Toll Free: 877-407-9205International: 201-689-8054

Those interested in listening to the conference call live via the internet may do so by visiting the "Investors & Media" page of BrainStorm's website atwww.ir.brainstorm-cell.comand clicking on the conference call link.

Event Link: Webcast URL: https://bit.ly/30pVpNG Webcast Replay Expiration: Friday, October 15, 2021

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

Replay Number:

Toll Free: 877-481-4010International: 919-882-2331Replay Passcode: 37811

Teleconference Replay Expiration:

Thursday, October 29, 2020

About NurOwn

NurOwn (autologous MSC-NTF) cells represent 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 can 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. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received acceptance from theU.S. Food and Drug Administration(FDA) to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS) and initiated enrollment inMarch 2019.

AboutBrainStorm 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 NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from theU.S. Food and Drug Administration(FDA) and theEuropean Medicines Agency(EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at sixU.S.sites supported by a grant from theCalifornia Institute for Regenerative Medicine(CIRM CLIN2-0989). The pivotal study is intended to support a filing forU.S.FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently receivedU.S.FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment inMarch 2019. For more information, visit the company's website atwww.brainstorm-cell.com.

ContactsInvestor Relations:Corey Davis, Ph.D.LifeSci Advisors, LLCPhone: +1 646-465-1138cdavis@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 Cell Therapeutics to Announce Third Quarter Financial Results and Provide a Corporate Upd - PharmiWeb.com

FREEHOLD, N.J., Oct. 01, 2020 (GLOBE NEWSWIRE) -- Avalon GloboCare Corp. (NASDAQ: AVCO), a clinical-stage global developer of cell-based technologies and therapeutics, today provided a clinical update on its chimeric antigen receptor (CAR) T-cell therapy and allogeneic mesenchymal stromal cell (MSC) therapy programs following successful completion of its Phase I clinical trial of AVA-001, the Companys leading CAR T-cell therapy candidate in development for patients with relapsed/refractory B-cell lymphoblastic leukemia (R/R B-ALL).

AVA-001

AVA-001 is a third generation CAR T-cell therapy which involves the 4-1BB (or CD28) co-stimulation signaling pathway, which we believe is designed to confer a more effective capacity for cancer cell-killing compared to older generation CAR T-cell therapies. As previously announced, Avalon has successfully completed a Phase I first-in-human clinical study of its leading CAR T-cell therapy candidate, AVA-001, for the treatment of R/R B-ALL (National Institute of Health clinical trial registration number: NCT03952923). Ninety percent of R/R B-ALL patients on trial achieved complete remission within one month of AVA-001 treatment and successfully proceeded to a curative-intent allogeneic bone marrow transplant.Accessory laboratory testing that accompanied this pilot clinical study has demonstrated evidence of enhancement in CAR T-cell persistence and protection against CAR T-cell exhaustion.

Given the positive results, Avalon is in the process of advancing AVA-001 CAR T-cell therapy for R/R B-ALL to the next phase of clinical development. In addition, Avalon is expanding its AVA-001 clinical trial to recruit patients with relapsed/refractory Non-Hodgkin lymphoma (R/R-NHL). This clinical paradigm of bridging CAR T-cell therapy to bone marrow transplant will provide a new therapeutic horizon with curative potential for patients with relapsed/refractory B-ALL, NHL and other hematologic malignancies.

CB-MSC-1

Avalons CB-MSC-1 is an innovative, allogeneic mesenchymal stromal cell (MSC) therapy candidate derived from human cord blood. Avalon plans to develop its MSC platform as a potential therapy for bone marrow transplant-related complications of acute graft-versus-host disease (aGVHD), and for acute respiratory distress syndrome (ARDS) associated with severe respiratory infection including SARS-CoV-2 virusthe causative agent of the ongoing global COVID-19 pandemic.

MSCs are typically isolated from the bone marrow, fat tissue and other tissue types and possess unique anti-inflammatory and immunomodulatory activities. These cells have the ability to suppress T-cell proliferation, cytokine secretion and regulate the balance of antibody-based and cell-based immune responses. MSCs can also tone down the abnormal release of antibodies from B-cells and cytokines from natural killer cells.

Avalon has completed pre-clinical studies and the standardized process development for its CB-MSC-1 cell therapy candidate, and anticipates initiation of a first-in-human clinical trial for aGVHD and ARDS during the fourth quarter of 2020. There is a substantial unmet need for the treatment of aGVHD and ARDS. Leveraging the Companys scientific and clinical expertise in cellular therapy and stem cell-derived exosome (ACTEX) technology, Avalon also plans to initiate a clinical trial of ACTEX-M, the clinical-grade exosomes derived from CB-MSC-1 as a candidate topical treatment for cutaneous aGVHD.

We are excited and encouraged by the clinical and technological progress we have made with these key cellular programs which are the cornerstone of Avalon, said David Jin, M.D., Ph.D., President and Chief Executive Officer of Avalon. We are committed to rapidly advancing these product candidates to address important unmet medical needs for patients, said David Jin, M.D., Ph.D., President and Chief Executive Officer of Avalon.

About Avalon GloboCare Corp.

Avalon GloboCare Corp. (NASDAQ: AVCO) is a clinical-stage, vertically integrated, leading CellTech bio-developer dedicated to advancing and empowering innovative, transformative immune effector cell therapy, exosome technology, as well as COVID-19 related diagnostics and therapeutics. Avalon also provides strategic advisory and outsourcing services to facilitate and enhance its clients' growth and development, as well as competitiveness in healthcare and CellTech industry markets. Through its subsidiary structure with unique integration of verticals from innovative R&D to automated bioproduction and accelerated clinical development, Avalon is establishing a leading role in the fields of cellular immunotherapy (including CAR-T/NK), exosome technology (ACTEX), and regenerative therapeutics. For more information about Avalon GloboCare, please visit http://www.avalon-globocare.com.

For the latest updates on Avalon GloboCare's developments, please follow our twitter at @avalongc_avco

Forward-Looking Statements

Certain statements contained in this press release may constitute "forward-looking statements." Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors as disclosed in our filings with the Securities and Exchange Commission located at their website (http://www.sec.gov). In addition to these factors, actual future performance, outcomes, and results may differ materially because of more general factors including (without limitation) general industry and market conditions and growth rates, economic conditions, and governmental and public policy changes. The forward-looking statements included in this press release represent the Company's views as of the date of this press release and these views could change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of the press release.

Contact Information:Avalon GloboCare Corp.4400 Route 9, Suite 3100Freehold, NJ 07728PR@Avalon-GloboCare.com

Investor Relations:Crescendo Communications, LLCTel: (212) 671-1020 Ext. 304avco@crescendo-ir.com

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Avalon GloboCare Provides Clinical Updates on Its CAR-T Immuno-Oncology and Allogeneic Mesenchymal Stromal Cell (MSC) Therapy Programs Following...

Targeted News Service Published 8:39 p.m. ET Oct. 2, 2020

WASHINGTON - Here's a look at how area members of Congress voted Sept. 25 to Oct. 1.

Along with its roll call votes, the House also passed these measures: the Cyber Sense Act (H.R. 360), to require the secretary of energy to establish a voluntary Cyber Sense program to test the cybersecurity of products and technologies intended for use in the bulk-power system; the Consumer Product Safety Inspection Enhancement Act (H.R. 8134), to support the Consumer Product Safety Commission's capability to protect consumers from unsafe consumer products; the School-Based Allergies and Asthma Management Program Act (H.R. 2468), to increase the preference given, in awarding certain allergies and asthma-related grants, to states that require certain public schools to have allergies and asthma management programs; and the Effective Suicide Screening and Assessment in the Emergency Department Act (H.R. 4861), to establish a program to improve the identification, assessment, and treatment of patients in the emergency department who are at risk of suicide.

House Vote 1:

PRESIDENTIAL ELECTION: The House has passed a resolution (H. Res. 1155), sponsored by Rep. Eric Swalwell, D-Calif., reaffirming the House's commitment to an orderly and peaceful transfer of presidential power after the November election. Swalwell said: "The peaceful transition of power is not only a bedrock principle of America's founding; it is a living ideal that we must exercise and pass down to our children." An opponent, Rep. Matt Gaetz, R-Fla., called the resolution "a way for Democrats to attack the president and disguise the fact that they will refuse to accept the election results unless they win." The vote, on Sept. 29, was 397 yeas to 5 nays.

YEAS: Bob Gibbs R-OH (7th), Troy Balderson R-OH (12th)

NOT VOTING: Jim Jordan R-OH (4th)

House Vote 2:

DISCLOSING TIES TO UYGHUR LABOR: The House has passed the Uyghur Forced Labor Disclosure Act (H.R. 6270), sponsored by Rep. Jennifer Wexton, D-Va., to require publicly traded companies to disclose whether they have business ties to China's Uyghur Autonomous Region in Xinjiang province. Wexton said the requirement would let investors know of a given company's "passive complicity or active exploitation of one of the most pressing and ongoing human rights violations of our lifetime." A bill opponent, Rep. Anthony Gonzalez, R-Ohio, said it wrongly tried to have the Securities and Exchange Commission police human rights violations, a role that would be better handled by the Treasury Department. The vote, on Sept. 30, was 253 yeas to 163 nays.

NAYS: Gibbs R-OH (7th), Balderson R-OH (12th),Jordan R-OH (4th)

House Vote 3:

DISEASE THERAPIES: The House has passed the Timely ReAuthorization of Necessary Stem-cell Programs Lends Access to Needed Therapies Act (H.R. 4764), sponsored by Rep. Doris O. Matsui, D-Calif. The bill would reauthorize a program for transplanting umbilical cord blood, stem cellsand bone marrow to adults and children suffering from various diseases. The vote, on Sept. 30, was unanimous with 414 yeas.

YEAS: Gibbs R-OH (7th), Balderson R-OH (12th),Jordan R-OH (4th)

House Vote 4:

FURTHER COVID-19 SPENDING: The House has approved an amendment to the America's Conservation Enhancement Act (H.R. 925). The amendment would spend $2.2 trillion on new COVID-19 measures, including testing and treatment efforts and unemployment benefits. A supporter, Rep. James P. McGovern, D-Mass., said the spending was needed "for families to pay for necessities like food, utilitiesand rent during this pandemic." An opponent, Rep. Tom Cole, R-Okla., said the amendment had been hurriedly brought to the floor without minority input or adequate time for review, and that it would not pass the Senate. The vote, on Oct. 1, was 214 yeas to 207 nays.

NAYS: Gibbs R-OH (7th), Balderson R-OH (12th),Jordan R-OH (4th)

Senate Vote 1:

CONTINUING APPROPRIATIONS: The Senate has passed the Continuing Appropriations Act and Other Extensions Act (H.R. 8337), sponsored by Rep. Nita M. Lowey, D-N.Y., to extend through Dec.11 funding for health programs, including Medicare, surface transportationand many other government programs. The vote, on Sept. 30, was 84 yeas to 10 nays.

YEAS: Sherrod Brown D-OH, Rob Portman R-OH

Senate Vote 2:

OBAMACARE LITIGATION: The Senate has rejected a cloture motion to end debate on a motion to consider a bill (S. 4653), sponsored by Senate Minority Leader Chuck Schumer, D-N.Y., that would block the Justice Department from making arguments in court for cancelling any provision of the 2010 health care reform law (Obamacare). The vote to end debate, on Oct. 1, was 51 yeas to 43 nays, with a three-fifths majority needed for approval.

YEAS: Brown D-OH

NAYS: Portman R-OH

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Here's how area members of Congress voted - Mansfield News Journal

NEW YORK--(BUSINESS WIRE)--Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) (Rocket), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, today announces two presentations at the European Society for Immunodeficiencies (ESID) 2020 Meeting to be held virtually October 14-17, 2020. An oral presentation will provide an update on data from the Phase 1/2 clinical trial of RP-L201 for Leukocyte Adhesion Deficiency-I (LAD-I). An e-poster will highlight preclinical study data on RP-L401 for Infantile Malignant Osteopetrosis (IMO).

Additional presentation details can be found below:

Oral Presentation

Title: A Phase 1/2 Study of Lentiviral-Mediated Ex-Vivo Gene Therapy for Pediatric Patients with Severe Leukocyte Adhesion Deficiency-I (LAD-I): Results from Phase 1 Session Title: TreatmentPresenter: Donald B. Kohn, M.D., Professor of Microbiology, Immunology and Molecular Genetics, Pediatrics (Hematology/Oncology), Molecular and Medical Pharmacology, and member of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at the University of California, Los AngelesSession Date: Friday, October 16, 2020Session Time: 10:45 a.m. 12:01 p.m. CESTLecture Time: 11:45 a.m. CESTLocation: Hall D

This session will be followed by a Q&A from 12:01 p.m. to 12:30 p.m. CEST

E-Poster

Title: Preclinical Efficacy and Safety of EFS.HTCIRG1-LV Supports IMO Gene Therapy Clinical Trial InitiationPresenter: Ilana Moscatelli, Ph.D., Associate Researcher, Division of Molecular Medicine and Gene Therapy, Lund University, Sweden

About Leukocyte Adhesion Deficiency-I

Severe Leukocyte Adhesion Deficiency-I (LAD-I) is a rare, autosomal recessive pediatric disease caused by mutations in the ITGB2 gene encoding for the beta-2 integrin component CD18. CD18 is a key protein that facilitates leukocyte adhesion and extravasation from blood vessels to combat infections. As a result, children with severe LAD-I (less than 2% normal expression) are often affected immediately after birth. During infancy, they suffer from recurrent life-threatening bacterial and fungal infections that respond poorly to antibiotics and require frequent hospitalizations. Children who survive infancy experience recurrent severe infections including pneumonia, gingival ulcers, necrotic skin ulcers, and septicemia. Without a successful bone marrow transplant, mortality in patients with severe LAD-I is 60-75% prior to the age of 2 and survival beyond the age of 5 is uncommon. There is a high unmet medical need for patients with severe LAD-I.

Rockets LAD-I research is made possible by a grant from the California Institute for Regenerative Medicine (Grant Number CLIN2-11480). The contents of this press release are solely the responsibility of Rocket and do not necessarily represent the official views of CIRM or any other Agency of the State of California.

About Infantile Malignant Osteopetrosis

Infantile Malignant Osteopetrosis (IMO) is a rare, severe autosomal recessive disorder caused by mutations in the TCIRG1 gene, which is critical for the process of bone resorption. Mutations in TCIRG1 interfere with the function of osteoclasts, cells which are essential for normal bone remodeling and growth, leading to skeletal malformations, including fractures and cranial deformities which cause neurologic abnormalities including vision and hearing loss. Patients often have endocrine abnormalities and progressive, frequently fatal bone marrow failure. As a result, death is common within the first decade of life. IMO has an estimated incidence of 1 in 200,000. The only treatment option currently available for IMO is an allogenic bone marrow transplant (HSCT), which allows for the restoration of bone resorption by donor-derived osteoclasts which originate from hematopoietic cells. Long-term survival rates are lower in IMO than those associated with HSCT for many other non-malignant hematologic disorders; severe HSCT-related complications are frequent. There is an urgent need for additional treatment options.

RP-L401 was in-licensed from Lund University and Medizinische Hochschule Hannover.

About Rocket Pharmaceuticals, Inc.

Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) (Rocket) is advancing an integrated and sustainable pipeline of genetic therapies that correct the root cause of complex and rare childhood disorders. The companys platform-agnostic approach enables it to design the best therapy for each indication, creating potentially transformative options for patients afflicted with rare genetic diseases. Rocket's clinical programs using lentiviral vector (LVV)-based gene therapy are for the treatment of Fanconi Anemia (FA), a difficult to treat genetic disease that leads to bone marrow failure and potentially cancer, Leukocyte Adhesion Deficiency-I (LAD-I), a severe pediatric genetic disorder that causes recurrent and life-threatening infections which are frequently fatal, Pyruvate Kinase Deficiency (PKD) a rare, monogenic red blood cell disorder resulting in increased red cell destruction and mild to life-threatening anemia and Infantile Malignant Osteopetrosis (IMO), a bone marrow-derived disorder. Rockets first clinical program using adeno-associated virus (AAV)-based gene therapy is for Danon disease, a devastating, pediatric heart failure condition. For more information about Rocket, please visit http://www.rocketpharma.com.

Rocket Cautionary Statement Regarding Forward-Looking Statements

Various statements in this release concerning Rocket's future expectations, plans and prospects, including without limitation, Rocket's expectations regarding its guidance for 2020 in light of COVID-19, the safety, effectiveness and timing of product candidates that Rocket may develop, to treat Fanconi Anemia (FA), Leukocyte Adhesion Deficiency-I (LAD-I), Pyruvate Kinase Deficiency (PKD), Infantile Malignant Osteopetrosis (IMO) and Danon Disease, and the safety, effectiveness and timing of related pre-clinical studies and clinical trials, may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward-looking statements, which often include words such as "believe," "expect," "anticipate," "intend," "plan," "will give," "estimate," "seek," "will," "may," "suggest" or similar terms, variations of such terms or the negative of those terms. Although Rocket believes that the expectations reflected in the forward-looking statements are reasonable, Rocket cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Rocket's ability to monitor the impact of COVID-19 on its business operations and take steps to ensure the safety of patients, families and employees, the interest from patients and families for participation in each of Rockets ongoing trials, our expectations regarding when clinical trial sites will resume normal business operations, our expectations regarding the delays and impact of COVID-19 on clinical sites, patient enrollment, trial timelines and data readouts, our expectations regarding our drug supply for our ongoing and anticipated trials, actions of regulatory agencies, which may affect the initiation, timing and progress of pre-clinical studies and clinical trials of its product candidates, Rocket's dependence on third parties for development, manufacture, marketing, sales and distribution of product candidates, the outcome of litigation, and unexpected expenditures, as well as those risks more fully discussed in the section entitled "Risk Factors" in Rocket's Annual Report on Form 10-Q for the quarter ended June 30, 2020, filed August 5, 2020 with the SEC. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and Rocket undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

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Rocket Pharmaceuticals Announces Two Presentations at the European Society for Immunodeficiencies 2020 Meeting - Business Wire

A baby whose nose bleed turned out to be a one-in-a-million disease has had his life saved by a complete stranger.

Tiny Daniel McAvoy's parents were told he would die unless he received the stem cell transplant before he turned two.

The infant was diagnosed with Wiskott-Aldrich syndrome, a rare blood disorder, when he was just ten weeks old.

Mum Georgie, 30, and dad Andrew, 37, noticed something wasnt right with their newborn when he suffered chronic nosebleeds and passed blood in his nappies.

But after desperately searching for the right donor for more than a year, Daniel has now had the transplant and is a smiley, happy tot back at home.

"Hes eating and playing and I really hope it continues that way. Im just so proud of him, hes done amazing," Georgie, of Benwick, Cambridgeshire, said today.

"There were plenty of times we thought he would die - we even had him christened in hospital because things werent looking great.

"He has the most severe level of the syndrome so from day one we were told he would need a transplant to replace his faulty immune system and defective cells and the procedure took place.

Doctors warned that he would go down quickly after the transplant but he hasnt and they're shocked."

When Daniel was first referred to hospital at three weeks old, medics first thought he had leukaemia, but after recovering from sepsis, he was discharged while they continued to look into the worrying case.

He was then rushed back to hospital at ten weeks old in July last year.

Georgie, who is a stay-at-home-mum, said: The nosebleeds went from nothing to doctors then telling us that he needed a bone marrow transplant to save his life.

He was diagnosed with Wiskott-Aldrich Syndrome in July 2019, which affects only one in a million boys and was the cause of the horrendous bleeds.

I never knew I was a carrier of the gene that causes it, so as a mum I felt pretty guilty that Id given him it."

The newborn woke up in May 2019 with a crust of blood on his nostril, which his parents thought was strange but a health visitor suggested it could be from a scratch.

But the tot began passing blood in vomit and nappies, and a GP then referred him to the hospital, where tests found he had a low platelet count that caused the bleeding.

Following a platelet transfusion to help stabilise him, Daniels parents were told he contracted sepsis but could also have meningitis and a rare type of leukaemia - so he was sent to a cancer ward.

Various procedures ruled out leukemia and out of nowhere the tiny tot began to get well again, so doctors discharged him.

Georgie added: Something still didnt sit right with me but some time later he had an unrelated hernia which needed an operation, and began having nose bleeds again.

I suggested that a doctor needed to look at the bigger picture because I knew there was something wrong with my baby.

The paediatrician looked back at all of Daniels notes and thought it was Wiskott-Aldrich Syndrome, which Id never heard of before, then after the operation to remove the hernia the haematologist agreed.

Within 24 hours of him being tested for this he was pretty much diagnosed and then doctors were speaking to us about bone marrow transplants - it all went very quickly.

In Daniels case, hes had a lot of bleeding problems - he bleeds from his gut, nose, eyes and mouth - so doctors were concerned about a catastrophic bleed that would kill him.

Wiskott-Aldrich Syndrome is a primary immunodeficiency which caused Daniels bleeding and left him prone to infections such as sepsis and also cancer.

He began having antibody infusions once a week as charities such as DKMS ran their global register to find a life-saving stem cell donor for Daniel, and a match was found in September 2019.

Georgie said: We had a terrifying 12 week wait but we were really fortunate that it was quick before a match was found.

His transplant then got delayed three times - the first and second times were because he wasnt well enough, and the third time was due to coronavirus.

I just went into panic mode because I thought he was going to die from this.

But Daniels transplant finally took place after a week-long chemo and immunotherapy course.

Were taking it day by day - if its successful, within two years he should be a healthy little boy.

Its all been a mixture of feelings - its really nice how hes so young that he wont remember how awful this all is but at the same time, sitting there watching your child have chemotherapy is the most heartbreaking thing in the world.

I would do anything to switch places with him.

Now that baby Daniel has been given another shot at life, his family are now calling out for others to join the transplant registers, as four out of ten patients arent lucky enough to get a match.

Georgie added: Its incredible how an anonymous donor saved Daniels life - without that person there would be no Daniel, they are all we needed to give him a second chance at life.

Its so simple and easy to sign up, and by doing so, you could save a babys life.

If you are aged between 17 and 55 and in general good health take the first step to register as a blood stem cell donor by registering for your home swab kit at http://www.dkms.org.uk.

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Baby whose nosebleeds turned out to be deadly condition saved by stranger - Mirror Online

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Stem Cell-Derived Cells Market Forecasted To Surpass The Value Of US$ XX Mn/Bn By 2019 - 2029 - Stock Market Funda

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It saddens me that when I tell people I have sickle cell the most common reply is what is that? sickle cell advocate Shamonica Wiggins shares with theGrio.

Sickle cell disease (SCD) is a group of red blood cell disorders occurring when a child inherits the sickle cell gene from both parents possessing the sickle cell trait. Those with the disease are often referred to as warriors because from the moment they are born, each day is its own battle.

Living with sickle cell has been a never-ending roller coaster, explains 31-year-old sickle cell warrior Shanice Williams. Sometimes everything is looking up, but the road is still bumpy mild to moderate crises and health issues. Other times Im flying down really fast always in crises, in the hospital, etc and I just have to wait until everything is going smooth again.

A sickle cell crisis occurs when the hard, sticky, sickle-shaped red blood cells of a SCD patient block blood flow causing extreme pain, anemia, fever and fatigue.

According to 24-year-old Sabah Imani, founder of the Sabah Imani Sickle Cell Foundation, sickle cell pain is almost indescribable. The best way I can put it is like having thousands and thousands of little needles running through your veins, something similar to a body part falling asleep but times 50.

In addition to the immense pain, sickle cell crises can also lead to a variety of serious ailments such as tissue damage, infections, fatal organ failure and stroke. Sickle cell warrior Tristan Lee, 37, suffered a stroke when he was 9 years old leaving him paralyzed on the left side of his body.

I spent months in the hospital after that, he says. When I was finally released, I had to do years of physical and occupational therapy to relearn how to walk, talk, and use the bathroom. I also had to begin routine blood transfusions every 3 weeks until I was 19 years old to avoid any risk of blood clots, and more complications from sickle cell.

Advocate Wiggins also suffered from strokes her first at the age of 3 and another more recently at the age of 30.

Experiencing something so traumatic, not once but twice, could break a person but I refuse to break. I bend from time to time, but breaking is not an option, she tells theGrio. As painful as this illness is, Im actually grateful that I have it. I truly believe learning to not only live, but thrive with this illness has made me a better person. It has made me a grateful person. An understanding person. A determined person and a compassionate person.

In between pain and hospitalizations, Wiggins spends her time advocating for the 100,000 Americans living with SCD. Earlier this month, that advocacy afforded her the opportunity to present at the White Houses roundtable discussion on Improving the Lives of Americans with Sickle Cell Disease.

I see sickle cell as a silent killer because although it claims the lives of so many nationwide and around the world, theres very little talk about it, so Im grateful for this platform, adds Wiggins.

Advocates like Wiggins, Imani, Williams, Lee, and 29-year-old Teonna Woolford are determined to drive the conversation forward, not simply for awareness, but because its truly a matter of life and death.

I would be irresponsible as an advocate if I did not speak on the fact that systemic racism and medical bias has held us back for far too long, says Woolford. Families impacted by sickle cell deserve the same quality and compassionate care as families impacted by other conditions such as cancer and cystic fibrosis. Sickle cell disease is far more prevalent than cystic fibrosis, yet we have far less resources.

Although sickle cell is not technically a Black disease, it is an evolutionary condition found most prevalent among people from regions of the world where malaria is common, including sub-Saharan Africa, South and Central America, Saudi Arabia, India and the Mediterranean (Greece, Sicily and Turkey). Because of this, SCD occurs in approximately 1 out of every 365 African-American births and 1 in 13 African Americans carry the sickle cell trait.

Ive been hospitalized over a hundred times, and some doctors would think, Heres this young Black person. Theyre just drug-seeking, shares 29-year-old Epiphany Samuels. What they dont understand is that Im in so much pain, Im praying for death, not drugs.

And Samuels is not alone. The pain of SCD is often as much a mental one as it is physical. Sickle cell warrior Hugh Holcomb shares that it gets really hard sometimes the loneliness from being in the hospital. Sometimes its hard to find the will to fight.

Because of this, Imani urges anyone who may know someone with SCDto really take the time to get to know and understand them.

Were so used to getting prejudged that all we want is for someone to take the time and care about us, just like you would for someone living with cancer or AIDS. As sickle cell patients, we do not look sick most of the time and that can be very misleading, she explains. We can be in the middle of the worst pain ever yet still sit and hold a conversation with you. We push ourselves to do certain activities that arent healthy for us but we just want that sense of normalcy.

Unfortunately, during this COVID-19 pandemic, normalcy is now a foreign concept even for those without SCD. But for people with underlying health conditions, this pandemic carries an extra layer of concern.

Were used to carrying sanitizer and always watching those around us for symptoms of being sick considering even a cold can push us into a crisis, or worse, possibly wind us up in ICU, says Williams.

And for Samuels, who found herself in the middle of a crisis at the height of the pandemic, navigating my sickle cell during coronavirus has been hard. There was this one moment where I was like, Oh, Epiphany, your eyes are turning green and youre in a whole lot of pain. Youre in a crisis.

She continues, I knew it was better for me to try to handle my crisis at home than to go to the ER because I can likely live through my crisis but I dont know if I can live through COVID.

Currently, the only known cure for SCD is a bone marrow or stem cell transplant from a close relative like a brother or sister. However, these procedures are extremely risky, and can have serious side effects, including frequent infections and death.

Both Imani and Woolford have undergone bone marrow transplants. Imani is now two years post transplant, and has since developed a skin care line based on the natural moisturizers she created to treat her drastically changing skin during chemotherapy and radiation treatments.

Unfortunately for Woolford, things didnt go quite as well.

It was a grueling process physically and even more so mentally, and at the end of my four-month hospital stay, I found out that I rejected the transplant, she says. That was 10 years ago, and probably the hardest thing I had ever been through. I had to let go of the dream that I would live a life free of sickle cell.

But in the years since, Woolford like many other sickle cell warriors has managed to transform her pain into power. Today, I am thriving and the happiest I have ever been. In a full circle moment, I contributed to the first ever publication of guidelines for bone marrow transplants and sickle cell disease through the American Society of Hematology. This is an incredible time for sickle cell disease. We recently had three new FDA-approved therapies after 20 years of having only one.

Tristan Lee shares in her optimism.

I believe, in my lifetime, we will have a universal cure for sickle cell disease. As long as we can continue to spread awareness and get medical professionals and people of all walks of life to join us in that awareness, we will have our cure that we desperately need.

Follow the above-mentioned advocates journeys via social media for more information on SCD.

This article is written in loving memory of Robert L. Stevenson.

Have you subscribed to theGrios new podcast Dear Culture? Download our newest episodes now!

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Life as a sickle cell warrior: How advocates are changing the face of the disease - TheGrio

Smiths 2005 stem cell law to be reauthorized by House

Rep. Chris Smith (R-NJ)statement submitted during debate in the House of Representatives

on the Stem Cell Therapeutic and Research ActSeptember 29, 2020

Margaret Hahnmy mother-in-lawpassed away on Friday and a Mass of Christian burial will be held today at St. Mary Church in South Amboy, New Jersey. She was 96 and was deeply loved and will be deeply missed.

MargaretPegwas a great womanwife, mother, grandmother, and great-grandmother. She selflessly devoted her life to public service including her amazing work as Sayreville Borough Clerk for twenty years. She had an incredible reputation for getting things done for the people. No matter who served as mayor or on Council, everyone knew she was the power.

My wife Marie and I will join family and friends today at her funeral and internment making it impossible for me to speak today during the debate on the reauthorization of a law I originally authored fifteen years agothe Stem Cell Therapeutic and Research Act of 2005and the Stem Cell Therapeutic and Research Act of 2015.

So, I submit these comments for the Congressional Record.

Madam Speaker, today the House of Representatives will vote to reauthorize the Stem Cell Therapeutic and Research Act.

This was an original idea of mine 20 years ago. Joined by 70 cosponsors, I introduced it in 2001 and again in 2003.

After five long years of hard work and numerous setbacks, my bill was finally enacted into law in 2005.

Beginning in 2001, Dr. Joanne Kurtzberg, who is President of the Cord Blood Association, helped draft my original law.Dr. Kurtzberg has said, Cord blood transplantation is now an established field with enormous potential. In the future, it may emerge as a source of cells for cellular therapies focused on tissue repair and regeneration.

The new law created a nationwide umbilical cord blood stem cell program, designed to collect, derive, type, and freeze cord blood units for transplantation into patients to mitigate and to even cure serious disease. Pursuant to the law, it also provided stem cells for research. The new cord blood program was combined in our 2005 law with an expanded bone marrow initiative, which was crafted over several years by our distinguished colleague, CongressmanBill Young.

I was the prime sponsor again when it was reauthorized in 2015.

Umbilical cord blood stem cells, obtained after the birth of a child, have proved highly efficacious in treating 70 diseases, including sickle-cell disease, lymphoma, and leukemia. And scientists are continuing to study and better understand the regenerative effects of cord blood cell therapies for other diseases and conditions. Bone marrow donations provide lifesaving transplants to treat diseases like blood cancer, sickle cell anemia, or inherited metabolic or immune system disorders.

The National Cord Blood Inventory (NCBI) provides funding to public cord blood banks participating in the program to allow them to expand the national inventory of cord blood units available for transplant. These units are then listed on the registry by the Be the Match Program. The funds appropriated thus far have led to an important increase in the overall number of high-quality cord blood units available through the national registry, including 150,000 NCBI units. Within the Be the Match registry, there are more than 783,000 NCBI units worldwide.

The Program registry allows patients and physicians to locate matching cord blood units, as well as adult donors for marrow and peripheral blood stem cells, when a family donor is not available. The Program is the worlds largest, most diverse donor registry, with more than 22 million volunteers and more than 300,000 public cord blood units. To date, the National Marrow Donor Program/Be The Match (NMDP), through its operation of the Program, has facilitated more than 100,000 transplants. More than 45,000 patients have receivedcord bloodtransplants, according Dr. Joanne Kurtzberg.

The reauthorization before us authorizes $23 million to be appropriated for fiscal year 2021 through fiscal year 2025. It also authorizes $30 million to be appropriated for fiscal years 2021 through 2025 for the bone marrow transplant program. This continues funding at the same levels authorized in the 2015 authorization bill.

Madam Speaker, each year nearly 4 million babies are born in America. In the past, virtually every placenta and umbilical cord was tossed as medical waste. Today, doctors have turned this medical waste into medical miracles.

Not only has God in His wisdom and goodness created a placenta and umbilical cord to nurture and protect the precious life of an unborn child, but now we know that another gift awaits us immediately after birth. Something very special is left behindcord blood that is teeming with lifesaving stem cells. Indeed, it remains one of the best kept secrets in America that umbilical cord blood stem cells and adult stem cells in general are curing people of a myriad of terrible conditions and diseasesover 70 diseases in adults as well as in children.

The legislation that is before us will enable even more patients to receive the treatments that they so desperately need.

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Smith's 2005 stem cell law to be reauthorized by House - InsiderNJ