Stem Cell Clinic

Post-Remission Therapy For AML: Allogeneic Stem-Cell Transplant – SurvivorNet

By Adult Stem Cells

When treating Acute Myeloid Leukemia, its important to recognize the distinction between remission and cure. When their Acute Myeloid Leukemia is in remission and everything looks good, a lot of patients say, Thanks. Im done, right? saysDr. Richard Stone, director of the Adult Acute Leukemia Program at Dana-Farber Cancer Institute in Boston.

Instead, when a patient enters remission, it signals that theyre ready for the final phase of treatment. Post-treatment therapy offers the chance of a cure. It also reduces the risk of a recurrence, which can be caused by residual leukemia cells that may have remained in the blood after treatment.

Oh no. Sorry, Dr. Ston tells patients who assume remission means their treatment is over. We need to give you some more therapy to kill off those residual, undetectable leukemia cells, so we can go from remission to cure, he explains.

And thats really what were talking about in AML therapy today. We want to get you into remission and we have a great chance of doing that in most patients. And we want to cure you with post-remission therapy.

And autologous stem cell transplant involves taking the patients own stem cells, giving them high doses of chemotherapy, and then giving those cells back. We dont do that very much, says Dr. Stone.

The other big choice isallogeneic stem cell transplant, often called bone marrow transplant.And thats where we give you, the patient, chemotherapy to put your immune system to sleep, says Dr. Stone, adding that sometimes radiation is included in the pre-transplant treatment plan for the same purpose.And then we give you cells from another individual.

We give you those (donor) cells to replenish your bone-marrow compartment, where we expect those donated cells tokill off the residual undetected leukemic cells. The result is called Graft vs. Leukemia effect, which means the donor cells have killed off any residual leukemia cells. Thats why stem-cell transplantation is a very effectiveanti-leukemic therapy, Dr. Stone explains.

Why dont we do it in everybody? he asks. Because its pretty dangerous and we dont do unless we really think thats the only way we have to cure you.

Learn more about SurvivorNet's rigorous medical review process.

Dr. Richard Stone is Director of the Adult Acute Leukemia Program at DFCI. Read More

When treating Acute Myeloid Leukemia, its important to recognize the distinction between remission and cure. When their Acute Myeloid Leukemia is in remission and everything looks good, a lot of patients say, Thanks. Im done, right? saysDr. Richard Stone, director of the Adult Acute Leukemia Program at Dana-Farber Cancer Institute in Boston.

Instead, when a patient enters remission, it signals that theyre ready for the final phase of treatment. Post-treatment therapy offers the chance of a cure. It also reduces the risk of a recurrence, which can be caused by residual leukemia cells that may have remained in the blood after treatment.

And thats really what were talking about in AML therapy today. We want to get you into remission and we have a great chance of doing that in most patients. And we want to cure you with post-remission therapy.

And autologous stem cell transplant involves taking the patients own stem cells, giving them high doses of chemotherapy, and then giving those cells back. We dont do that very much, says Dr. Stone.

The other big choice isallogeneic stem cell transplant, often called bone marrow transplant.And thats where we give you, the patient, chemotherapy to put your immune system to sleep, says Dr. Stone, adding that sometimes radiation is included in the pre-transplant treatment plan for the same purpose.And then we give you cells from another individual.

We give you those (donor) cells to replenish your bone-marrow compartment, where we expect those donated cells tokill off the residual undetected leukemic cells. The result is called Graft vs. Leukemia effect, which means the donor cells have killed off any residual leukemia cells. Thats why stem-cell transplantation is a very effectiveanti-leukemic therapy, Dr. Stone explains.

Why dont we do it in everybody? he asks. Because its pretty dangerous and we dont do unless we really think thats the only way we have to cure you.

Learn more about SurvivorNet's rigorous medical review process.

Dr. Richard Stone is Director of the Adult Acute Leukemia Program at DFCI. Read More

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Post-Remission Therapy For AML: Allogeneic Stem-Cell Transplant - SurvivorNet

Intermittent fasting might boost the creation of new neurons in a key brain structure – PsyPost

By Adult Stem Cells

The connection between what and when we eat, and the structure and functionality of the brain, is one of the most complex relationships in modern medicine. But understanding this relationship will lead to fewer diseases, healthier minds, and longer lives. One regimen in particular, Intermittent Fasting (IF), has been shown to bolster the creation of new neurons (a process known as neurogenesis) in the hippocampus, a part of the brain involved in short and long term memory (and also one of the first casualties of Alzheimers disease).

Intermittent Fasting is a type of diet in which one regularly forgoes food for a certain period of time, usually somewhere between 14 and 18 hours. While its been known that IF increases the rate of hippocampal neurogenesis, the precise nature of the relationship is still poorly understood. To remedy this, researchers from the Universities of Singapore and Sungkyunkwan in Korea took a closer look at how IF affected change in the hippocampi of mice over a three month period in new research published in Brain and Behavior.

The mice were randomly assigned to four dietary groups: a control with no restrictions, and 12-hour, 16-hour and 24-hour fasted diets. The 12- and 16-hour groups fasted from either 3PM or 7PM to 7AM the next day, while the 24-hour group fasted every other day. Despite the varied schedules, all the mice ended up eating roughly the same number of calories.

As expected, all three dietary groups showed increased levels of neurogenesis in the hippocampus, with the most significant change in 16-hour mice. To better understand what was going on, the authors used a procedure called an immunoblot analysis, which can accurately detect certain proteins in a given tissue sample.

The analysis revealed an increased activation of the Notch signaling pathway, a type of cell-to-cell communication thats important to cell differentiation, the process by which immature cells, like stem cells, take on a permanent form and function. In humans, Notch signaling is related to hippocampal neuroplasticity, the brains ability to create new connections, allowing us to learn and form new memories.

We still have a long way to go before fully understanding how our diets affect the structure and function of our brains. Studies like this one can help us make better-informed decisions for leading healthier and longer lives, while retaining our memories and maintaining cognitive faculties.

The study, Intermittent fasting increases adult hippocampal neurogenesis, was authored by SangHa Baik, Vismitha Rajeev, David YangWei Fann, DongGyu Jo, and Thiruma V. Arumugam.

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Intermittent fasting might boost the creation of new neurons in a key brain structure - PsyPost

Twins Daily: How would a shortened season impact MLB injuries? – Bring Me The News

By Platelet Rich Plasma Injections

Andy Witchger / Bring Me The News

When major league baseball will resume is anybodys guess. But assuming baseball does have some semblance of a season during the 2020 calendar year, how will it impact the health of MLBers, however stunted it may be?

When major league baseball will resume is anybodys guess. But assuming baseball does have some semblance of a season during the 2020 calendar year, how will it impact the health of MLBers, however stunted it may be?

In many ways this is an impossible question to answer with any sort of confidence at this time. For instance, we dont know when the season will begin, when it will end, the amount of doubleheaders it will contain, if roster sizes will extend and for how long, nor to what extent will there be an extended Spring Training, among other factors that may be in play during the upcoming season.

It seems intuitive that injury rates may increase during the upcoming season as athletes and teams will assuredly have less time to prepare physically compared to a typical season with a typical Spring Training; during the strike-shortened 1995 season, MLB had a three-week Spring Training prior to beginning the regular season on April 25th, which may serve as precedent for how MLB will handle the upcoming season.

While athletes around the league are doing their best to remain in game-shape, each week without access to live pitching and batting practice at game speed decreases the likelihood that the athletes will remain ready for action.

There is some debate, however, regarding the role that Spring Training plays in athlete injury prevention. Spring Training likely decreases injury rates as many musculoskeletal injuries - among athletes as well as the lay population - occur after a sharp increase in activity which was preceded by relatively less activity, however, to what extent is unknown and likely impossible to study with a high-degree of accuracy.

Injury rates are usually highest among MLB athletes during the early portions of the season. A study conducted in 2011 found that injury rates during the 2002-2008 seasons were highest during April (5.73 injuries per 1,000 athlete exposures) and steadily decreased throughout the rest of the season, bottoming out at an injury rate of 0.54 during September.

Later studies published in 2019 and 2020 found that lower body and upper body injuries, respectively, suffered during the 2010-2016 seasons had the highest occurrence during the month of April (24% of all upper extremity and 21% of all lower extremity injuries suffered over the six year timeframe); these same studies found, perhaps unsurprisingly, that pitchers were more likely to suffer upper extremity injuries, whereas position players were more likely to suffer lower extremity injuries.

This is a guess, but it would not surprise me to see an increase in the rate of lower extremity soft tissue injuries - i.e. muscle strains - during the first month or two of the 2020 regular season compared to other seasons, particularly among position players, due in large part to the likely shortened Spring Training interval.

However, as long as pitchers are stretched out and brought along at an appropriate pace - such as capping pitch counts and limiting innings - I could see upper extremity injuries maintaining similar rates compared to previous seasons.

In all reality, it will be impossible to know how the shortened season impacts MLB athlete injury occurrence until after the 2020 season has been completed, and even then how late the season extends into the calendar year as well as the percentage of games that are played as doubleheaders will likely influence the overall rates of injury. We may never truly know the answer as to how MLB athlete health was impacted during the 2020 season.

Blaine Hardy Undergoes Tommy John SurgeryPhil Miller of the Star Tribune dropped a surprising nugget Saturday afternoon when he reported that reliever Blaine Hardy underwent Tommy John surgery recently to address a torn UCL and damaged flexor-pronator mass in his left elbow. Hardy was signed to a minor league contract by the Twins during the offseason.

Hardy dealt with left elbow pain during his 2019 campaign with the Detroit Tigers - spending time on the injured list twice, including a 60-day stint - and received a PRP injection in August to address his pain under the recommendation of famed orthopedic surgeon Dr. James Andrews.

PRP injections involve removing blood from the athlete, separating the plasma from the red blood cells, and injecting the plasma into the injured tissue; PRP is shorthand for platelet-rich plasma as the injected plasma is composed primarily of platelets and water. Platelets, which are small cells primarily involved with clotting, also release healing factors such as hormones.

The increased density of platelets within the injected plasma theoretically spurs the tissue to recover at an higher-rate, however, the true efficacy of PRP injections is debated.

The typical timeframe of return-to-play after Tommy John surgery is 12-18 months.

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This story first appeared at Twins Daily and was re-shared through a collaboration with Bring Me The News.

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Muscular Dystrophy Association Announces Formation of Strategic Medical Advisory Team of Experts in Neuromuscular Care and Research – BioSpace

By Gene Therapy Clinics

NEW YORK, April 2, 2020 /PRNewswire/ --TheMuscular Dystrophy Association(MDA) announced today the formation of its formal Medical Advisory Team who provide MDA with strategic guidance on issues that impact research and clinical care for people living with muscular dystrophy, amyotrophic lateral sclerosis (ALS) and related neuromuscular disorders more than 43 diseases. Each of the team members is a leading clinician at an MDA Care Center and is an internationally known expert in muscular dystrophy, ALS and related neuromuscular diseases. The MDA Care Center network spans over 150 locations at the nation's top medical institutions.

"We believe that engaging this team of world-class experts across neuromuscular diseases will enable MDA to lead the way in speeding the development of groundbreaking therapies and treatment paradigms that will transform the lives of those we serve," says Lynn O'Connor Vos, President and CEO of MDA. "These physicians are pillars of the neuromuscular disease community, each with focused expertise in specific diseases. Together, they will provide critical advice to MDA on our innovations in science and care programs and help ensure that we are making the maximum impact as the landscape of neuromuscular research, care and treatments evolve."

MDA's medical advisors will help lead the effort, along with more than 2,000 health care providers, to establish new clinical trials geared toward integration of MDA's innovative MOVR technology hub, which allows clinicians and researchers to share a wealth of disease-related information, establish professional protocols, and accelerate innovation.

Tonight, Dr. Barry Byrne, who will serve as chief medical advisor for the team, is joining MDA's EVP, Chief Advocacy & Care Services Officer, Kristin Stephenson for an MDA Facebook Live conversation about the precautions and best practices needed to protect the neuromuscular community in light of COVID-19. The event, scheduled for Thursday, April 2 from 6:00 to 6:30 pm EDT is accessible at https://www.facebook.com/MDAOrg/. The recording will be available for viewing after the event on MDA's COVID-19 resource page. The conversation will feature a live Q&A answering questions from people living with muscular dystrophy, ALS and related neuromuscular diseases including MDA families, and aims to provide the answers to questions regarding care duringthese uncertain times, and will cover topics related to preparedness, community impact, telemedicine and MDA's Care Center network of over 150 multidisciplinary care teams at top medical institutions nationwide.

Barry J. Byrne, MD, PhD, is an ardent supporter of newborn screening and has been an innovator and early adopter of new FDA-approved therapies that have the potential to alter the course of some neuromuscular disorders. He was the first physician to administer an approved gene therapy to a neuromuscular patient in the U.S.

"We are just beginning to realize the impact of the current revolution in the treatment of neuromuscular disorders. Newborn screening and access to newly-approved therapies are changing patients' lives when diagnosed with neuromuscular diseases; the MDA Care Center network is ready to provide these innovative treatments," says Dr. Byrne. "Disease-modifying therapies are no longer a thing of the future. There is an urgent need to bring innovative care, cutting-edge clinical research and new breakthrough treatments to the community."

Dr. Byrne will continue in his role as the associate chair of pediatrics and director of the Powell Gene Therapy Center at the University of Florida College of Medicine as he assumes this new position. He is also director of the MDA Care Center at the University of Florida.

Matthew B Harms, MD, will serve as a medical expert on ALS and other neuromuscular disorders. He is active in clinical research. Dr. Harms is associate professor of neurology at Columbia University's Vagelos College of Physicians and Surgeonsand serves at MDA's ALS Care Center at Columbia University. Dr. Harms received MDA's Diamond Award for his work directing an international effort with whole genome and transcriptome sequencing to bring precision medicine to ALS treatments.

John W. Day, MD, PhD, completes the Medical Advisory Team. Dr. Day is professor of neurology and pediatrics and director, Division of Neuromuscular Medicine at Stanford University. He directs Stanford's MDA Care Centers, which uniquely integrate the Lucile Packard Children's Hospital Pediatric and Transitional Neuromuscular Clinic with the Stanford Hospital Neuroscience Health Center's Neuromuscular and ALS Research and Clinic.The comprehensive team of investigators and clinicians in the Stanford Neuromuscular Program have helped develop novel gene modification and gene replacement treatments for spinal muscular atrophy, muscular dystrophy and ALS, and have spearheaded development of centralized data hubs like MDA's MOVR for neuromuscular disease.

About Barry J. Byrne, MD, PhD

Dr. Byrne is a clinician scientist who is studying a variety of rare diseases with the specific goal of developing therapies for inherited muscle disease. As a pediatric cardiologist, his focus is on conditions that lead to skeletal muscle weakness and abnormalities in heart and respiratory function. His group has made significant contributions to the understanding and treatment of Pompe disease, a type of neuromuscular disorder caused by an excess of a type of sugar (glycogen) in certain muscles. The research team has pioneered the use of adeno-associated virus (AAV) mediated gene therapy to restore heart and skeletal muscle function in Duchenne muscular dystrophy, Pompe, Friedrich's ataxia and other neuromuscular diseases. His group at the Powell Center has also established a series of new methods for large-scale AAV manufacturing to enable access for a wide variety of conditions.

About Matthew B. Harms, MD

Dr. Harms' post-doctoral and faculty work in neurogenetics led to the discovery of genes for dominant spinal muscular atrophy and limb-girdle muscular dystrophy type 1D. He sees patients in the Eleanor and Lou Gehrig ALS Center, the Adult Muscular Dystrophy Association Clinic, the Pediatric Muscular Dystrophy Association Clinic, and until recently, the ALS Clinic of the Bronx VA Hospital. His laboratory straddles Columbia's Motor Neuron Center and the Institute for Genomic Medicine, with a focus on generating, integrating, and analyzing clinical, genomic and transcriptomic datasets for amyotrophic lateral sclerosis and other neurological disorders.

About John W. Day, MD, PhD

Dr. Day has combined his expertise in synaptic physiology, genetics and neuromuscular medicine to help define the molecular mechanisms underlying myotonic dystrophy and other muscular dystrophies, neuropathies and ataxias. Under his leadership, the Stanford Neuromuscular Program is dedicated to the elucidation and treatment of neuromuscular diseases, integrating clinical care and clinical research with Stanford's basic science and translational programs. All Stanford pediatric and adult neuromuscular patients are asked to participate in research and are followed over time with functional evaluations. The Stanford Neuromuscular Program mission aligns fully with the goals of the MDA: to diagnose, investigate and characterize neuromuscular disorders precisely and completely; to develop novel treatments for neuromuscular disease; to incorporate novel treatments into the comprehensive care of patients with neuromuscular disorders; to advocate and support patients and families affected by neuromuscular disease so they can live life as fully and independently as possible; and to train the next generation of experts in neuromuscular diagnosis, care and research.

About MDA

MDA is committed to transforming the lives of people affected by muscular dystrophy, ALS, and related neuromuscular diseases. We do this through innovations in science and innovations in care. As the largest source of funding for neuromuscular disease research outside of the federal government, MDA has committed more than$1 billionsince our inception to accelerate the discovery of therapies and cures. Research we have supported is directly linked to life-changing therapies across multiple neuromuscular diseases. MDA's MOVR is the first and only data hub that aggregates clinical, genetic, and patient-reported data for multiple neuromuscular diseases to improve health outcomes and accelerate drug development. MDA supports the largest network of multidisciplinary clinics providing best in class care at more than 150 of the nation's top medical institutions. Our Resource Center serves the community with one-on-one specialized support, and we offer educational conferences, events, and materials for families and healthcare providers. Each year thousands of children and young adults learn vital life skills and gain independence at summer camp and through recreational programs, at no cost to families. For more information visitmda.org.

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SOURCE Muscular Dystrophy Association

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Unproven Stem Cell Therapy Gets OK for Testing in Coronavirus Patients – The New York Times

By Stell Cell Research

At least one outside expert said the approach could present safety risks. Paul Knoepfler, a stem cell researcher at the University of California, Davis, said that patients with coronavirus can develop severe reactions where their immune systems go too far in attacking cells in their lungs, causing damaging inflammation. Other cell therapies tested in China are designed to dampen the immune response. He said one risk with the natural killer cells is they could go in the other direction, exacerbating respiratory problems by massive killing of the patients respiratory cells.

Despite the scant evidence, Mr. Giuliani has become an early booster, interviewing Dr. Hariri on a podcast published on his website Saturday, and praising the treatment on Twitter, saying, this therapy has real potential. In a tweet on Saturday, he added, Lets hope F.D.A. can recognize that their cumbersome process designed to keep us safer, if it is not altered dramatically in times of great need, can result in unimaginable loss of human life.

Around the same time, Twitter deleted a post by Mr. Giuliani that it said violated its rules. The tweet, from March 27, made unfounded claims about the malaria drug hydroxychloroquine, one of the treatments that Mr. Trump has supported.

Dr. Hariri said that he has known Mr. Giuliani for years and that the appearance on his podcast was a friendly chat between people who know each other and who share a common interest in this particular response to this disease.

He said that he has no business relationship with Mr. Giuliani, and that Mr. Giuliani is not representing him in any way, either paid or unpaid. I dont have anything to do with what the mayor tweets or whatnot, and I dont agree or disagree with anything, he said.

Dr. Hariri said the company would follow the established process for testing whether a drug works. We have waited for the F.D.A. to complete their review, which they did in a heroic and quick fashion, he said.

On Wednesday evening the same day the F.D.A. approved his trial Dr. Hariri praised the appearance by the agencys commissioner, Dr. Stephen Hahn, on the conservative Fox News talk show The Ingraham Angle.

We are fortunate to have Dr. Hahn at the helm, he tweeted.

Link:
Unproven Stem Cell Therapy Gets OK for Testing in Coronavirus Patients - The New York Times

Stem Cell Therapy for Colon Cancer – Yahoo Finance

By Stell Cell Research

WASHINGTON, April 2, 2020 /PRNewswire/ -- An article published in Experimental Biology and Medicine (Volume 245, Issue 6, March 2020) (https://journals.sagepub.com/doi/pdf/10.1177/1535370220910690) examines the safety of stem cell therapy for the treatment of colon cancer.The study, led by Dr. J. Liu in the State Key Laboratory of Bioreactor Engineering and Shanghai Key Laboratory of New Drug Design at the East China University of Science and Technology in Shanghai (China), reports that mesenchymal stem cells from a variety of sources promote the growth and metastasis of colon cancer cells in an animal model.

Mesenchymal stem (MSCs), a category of adult stem cells, are being evaluated as therapy for numerous cancers.MSCs are excellent carriers for tumor treatment because they migrate to tumor tissues, can be genetically modified to secrete anticancer molecules and do not elicit immune responses.Clinical trials have shown that MSCs carrying modified genes can be used to treat colon cancer as well as ulcerative colitis. However, some studies have demonstrated MSCs can differentiate into cancer-associated fibroblasts and promote tumor growth.Therefore, additional studies are needed to evaluate the safety of MSCs for targeted treatment of colon cancer.

In the current study, Dr. Liu and colleagues examined the effects of mesenchymal stem cells (MSCs) from three sources (bone marrow, adipose and placenta) on colon cancer cells.MSCs from all three sources promoted tumor growth and metastasis in vivo. In vitro studies demonstrated that MSCs promote colon cancer cell stemness and epithelial to mesenchymal transition, which would enhance tumor growth and metastasis respectively.Finally, the detrimental effects of MSCs could be reversed by blocking IL-8 signaling pathways. Dr. Ma, co-author on the study, said that "Mesenchymal stem cells have a dual role: promoting and/or suppressing cancer. Which effect is dominant depends on the type of tumor cell, the tissue source of the MSC and the interaction between the MSC and the cancer cell. This is the major issue in the clinical application research of MSCs, and additional preclinical experimental data will be needed to evaluate the safety of MSCs for colon cancer treatment."

Dr. Steven R. Goodman, Editor-in-Chief of Experimental Biology & Medicine, said: "Lui and colleagues have performed elegant studies on the impact of mesenchymal stem cells (MSCs), from various sources, upon the proliferation, stemness and metastasis of colon cancer stem cells (CSCs) in vitro and in vivo. They further demonstrate that IL-8 stimulates the interaction between colon CSCs and MSCs, and activates the MAPK signaling pathway in colon CSCs.This provides a basis for the further study of MSCs as a biologic therapy for colon cancer."

Experimental Biology and Medicine is a global journal dedicated to the publication of multidisciplinary and interdisciplinary research in the biomedical sciences. The journal was first established in 1903. Experimental Biology and Medicine is the journal of the Society of Experimental Biology and Medicine. To learn about the benefits of society membership, visit http://www.sebm.org. For anyone interested in publishing in the journal, please visit http://ebm.sagepub.com.

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Stem Cell Therapy for Colon Cancer - Yahoo Finance

Evotec Expands its iPSC-Based Cell Therapy Platform EVOcells Through Licensing Agreement with panCELLa – BioSpace

By Stell Cell Research

HAMBURG, Germany and TORONTO, April 2, 2020 /CNW/ - Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) and the innovative biotechnology company panCELLa Inc. announced today that the companies have entered into a licensing and investment agreement.

Under the terms of the agreement, Evotec will receive a non-exclusive licence to access panCELLa's proprietary iPS cell lines "iACT Stealth Cells", which are genetically modified to prevent immune rejection of derived cell therapy products ("cloaking"). Furthermore, Evotec will also have access to a new-generation cloaking technology known as hypoimmunogenic cells. In addition, the "FailSafe" mechanism effectively addresses a key challenge in iPSC-based cell therapy, potential tumour formation by residual undifferentiated cells.

Using the cell lines, Evotec will be able to develop iPSC-based, off-the-shelf cell therapies with long-lasting efficacy that can be safely administered to a broad population of patients without the use of medication to supress the patients' immune system. With a growing portfolio of iPSC-based cell therapy projects at Evotec, access to research as well as GMP-grade iPSC lines modified with one or both of the panCELLa technologies significantly accelerates Evotec's cell therapy discovery and development efforts. Modified iPSC lines will be available for the development of cell therapy approaches across a broad range of indications by Evotec and potential partners. Furthermore, Evotec has made an investment to take a minority stake in panCELLa and has nominated Dr Andreas Scheel to join panCELLa's supervisory board.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "Cell therapies hold enormous potential as truly regenerative or curative approaches for a broad range of different diseases with significant medical need. Integrating panCELLa's technology and cell lines into our ongoing proprietary research and development efforts strengthens Evotec's position in cell therapy. It is our goal to provide safe highly-effective cell therapy products to as many patients as possible. In addition to small molecules and biologics, cell therapy will become yet another major pillar of Evotec's multimodality discovery and development platform."

Mahendra Rao, MD, PhD, CEO at panCELLa, added: "We welcome the partnership with Evotec. Evotec's widely recognised expertise and existing portfolio of iPSC-related technology platforms will allow panCELLa to rapidly advance its own therapeutic interests in NK cell therapy, pancreatic islet production and iPSC-derived MSC platform, in addition to enabling panCELLa to make its platform technologies widely available. I believe that the investment by Evotec in our company is a strong validation of the leading role of panCELLa in the field of regenerative medicine and in the utility of its platform technologies. We welcome Dr Andreas Scheel to our Board."

No financial details of the agreement were disclosed.

About Evotec and iPSCInduced pluripotent stem cells (also known as iPS cells or iPSCs) are a type of pluripotent stem cell that can be generated directly from adult cells. The iPSC technology was pioneered by Shinya Yamanaka's lab in Kyoto, Japan, who showed in 2006 that the introduction of four specific genes encoding transcription factors could convert adult cells into pluripotent stem cells. He was awarded the 2012 Nobel Prize along with Sir John Gurdon "for the discovery that mature cells can be reprogrammed to become pluripotent". Pluripotent stem cells hold great promise in the field of regenerative medicine. Because they can propagate indefinitely, as well as give rise to every other cell type in the body (such as neurons, heart, pancreatic and liver cells), they represent a single source of cells that could be used to replace those lost to damage or disease.

Evotec has built an industrialised iPSC infrastructure that represents one of the largest and most sophisticated iPSC platforms in the industry. Evotec's iPSC platform has been developed over the last years with the goal to industrialise iPSC-based drug screening in terms of throughput, reproducibility and robustness to reach the highest industrial standards, and to use iPSC-based cells in cell therapy approaches via the Company's proprietary EVOcells platform.

About cell therapy and panCELLa's FailSafe iPSC technologyCell therapy, one of the most promising regenerative medicine approaches, replaces a patient's missing or broken cells with functioning cells from a range of different sources, either from a donor, from the patient's own material, or from stem cells. The advent of induced pluripotent stem cells ("iPSC") has opened up stem cells as an almost unlimited source of consistent-quality material for such cell therapies. At the same time, differentiating cell therapies from a single validated source circumvents critical risks of contamination associated with administering both donor and patient cell material.

However, the patient's immune system will treat such iPSC-based transplant as "foreign" and use the body's immune system to counteract the therapy, thus undermining its long-term efficacy. While organ transplants require an often lifelong regimen of immunosuppressants, iPSC-derived cells used for cell therapies can be cloaked to make them undetectable by the patient's immune system, thus avoiding rejection and enabling effective long-term relief of the patient's symptoms.

To increase the safety of such iPSC-derived cell products, panCELLa's proprietary FailSafe technology is able to inactivate any iPSC-derived proliferating cell before and after transplantation through the use of a readily available anti-infective medication. FailSafe is the only quantifiable "safety switch" on the market which is expected to be critical for regulators, clinicians and patients to make informed decisions when evaluating treatment options.

About panCELLa Inc. Incorporated in August 2015, panCELLa (www.pancella.com) was founded by Dr Andras Nagy and Dr Armand Keating based on Dr Nagy's ground-breaking work in the area of stem cell research. Through panCELLa, Drs Keating and Nagy are seeking to create an effective cell therapy derived from stem cells, which are modified to provide a sufficient and very high level of safety before and after the cells are introduced to the patient. panCELLa serves those companies developing products from stem cells. panCELLa seeks to create universal "off the shelf" FailSafe Cells and to assist pharmaceutical and biotechnology sectors to achieve such with their own cell lines. Targeted medical applications include deadly, debilitating, or aggressive diseases requiring immediate treatment where there is no time to cultivate a customized stem cell treatment from the patient (i.e. cancer, cardiac infarct, diabetes, stroke and spinal cord injury).

About Evotec SEEvotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. We operate worldwide and our more than 3,000 employees provide the highest quality stand-alone and integrated drug discovery and development solutions. We cover all activities from target-to-clinic to meet the industry's need for innovation and efficiency in drug discovery and development (EVT Execute). The Company has established a unique position by assembling top-class scientific experts and integrating state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas including neuronal diseases, diabetes and complications of diabetes, pain and inflammation, oncology, infectious diseases, respiratory diseases, fibrosis, rare diseases and women's health. On this basis, Evotec has built a broad and deep pipeline of approx. 100 co-owned product opportunities at clinical, pre-clinical and discovery stages (EVT Innovate). Evotec has established multiple long-term alliances with partners including Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, CHDI, Novartis, Novo Nordisk, Pfizer, Sanofi, Takeda, UCB and others. For additional information please go to http://www.evotec.com and follow us on Twitter @Evotec.

FORWARD LOOKING STATEMENTSInformation set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of Evotec as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.

SOURCE panCELLa Inc.

Company Codes: Frankfurt:EVT, OTC-PINK:EVTCY

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Evotec Expands its iPSC-Based Cell Therapy Platform EVOcells Through Licensing Agreement with panCELLa - BioSpace

Fluidigm CyTOF Technology Used to Evaluate Stem Cell Therapy as a Potential Treatment for COVID-19 Pneumonia – Yahoo Finance

By Stell Cell Research

SOUTH SAN FRANCISCO, Calif., April 02, 2020 (GLOBE NEWSWIRE) -- Fluidigm Corporation(FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today announced that Fluidigm CyTOF technology was used in a clinical study producing preliminary evidence that mesenchymal stem cell (MSC) therapy improves outcomes in patients with COVID-19 pneumonia, providing key information about potential mechanisms of action of the treatment strategy.

Results of the study, conducted by researchers in China, have been published in Aging and Disease.1

We used a 36-marker CyTOF panel to generate a broad immune profile of each patients peripheral blood before and after transplantation, said Wenjing Wang, PhD, Associate Professor at Beijing Hepatology Research Institute, Youan Hospital. Mass cytometry allowed us to look at all immune populations of interest in a single tube of peripheral blood mononuclear cells, enabling us to use less sample and to simplify our workflow and analysis.

The study, which evaluated clinical outcomes as well as changes in inflammatory and immune function for 14 days in seven patients with COVID-19 pneumonia, indicated that intravenous transplantation of MSCs was a safe and effective treatment for patients with COVID-19 pneumonia, including for those in severe condition.

Pulmonary function and symptoms of these seven patients were significantly improved within two days of MSC transplantation. Three of the patients, including one classified as severe, recovered and were discharged 10 days after treatment.

CyTOF analysis found that MSC treatment of severe cases led to disappearance in three to six days of overactivated cytokine-secreting immune cells and increases in regulatory T and dendritic cells. Importantly, there was a dramatic increase in a population of CD14+CD11c+CD11bmidregulatory dendritic cells, which may have helped to tamp down the cytokine storm associated with COVID-19 respiratory disease. Separate analysis of patient serum found significant reduction in levels of TNF-, a potent inflammatory cytokine, while IL-10, an anti-inflammatory cytokine, increased in the MSC treatment group compared to the placebo control group.

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This level of new and valuable treatment research based on broad-based immune profiling is an important front in the COVID-19 fight, said Chris Linthwaite, President and CEO of Fluidigm. Fluidigm is actively engaged with many researchers in government and medical institutions who are addressing the COVID-19 pandemic from the perspectives of both immune profiling and virus detection and testing, and this study underscores the critical role that our technologies are playing in the global response to the outbreak.

In addition to our instruments, our assays and analysis software are increasingly the focus of customers in the global research community exploring immune profiling of COVID-19 infected populations. Our Maxpar Direct Immune Profiling Assay and Maxpar Pathsetter analysis software are a solution for labs seeking an easily deployed, fixed panel that can incorporate novel exploratory markers as well as standard markers, Linthwaite said.

We are inspired by this opportunity to provide meaningful tools in efforts to develop innovative solutions to this rapidly evolving pandemic.

About FluidigmFluidigm(FLDM) focuses on the most pressing needs in translational and clinical research, including cancer, immunology, and immunotherapy. Using proprietary CyTOF and microfluidics technologies, we develop, manufacture, and market multi-omic solutions to drive meaningful insights in health and disease, identify biomarkers to inform decisions, and accelerate the development of more effective therapies. Our customers are leading academic, government, pharmaceutical, biotechnology, and plant and animal research laboratories worldwide. Together with them, we strive to increase the quality of life for all. For more information, visitfluidigm.com.

Fluidigm, theFluidigmlogo, CyTOF, Direct, Immune Profiling Assay, Maxpar, and Pathsetter are trademarks and/or registered trademarks ofFluidigm Corporationinthe United Statesand/or other countries. Fluidigm products are provided for Research Use Only. Not for use in diagnostic procedures.

Forward-Looking Statements for FluidigmThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, among others, statements regarding the implementation of Fluidigm microfluidics technology and products by third parties and the anticipated benefits of, and applications and demand for, such products. Forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from currently anticipated results, including but not limited to risks relating to the potential adverse effects of the coronavirus pandemic on our business and operating results during 2020; challenges inherent in developing, manufacturing, launching, marketing, and selling new products; risks relating to company research and development and distribution plans and capabilities; interruptions or delays in the supply of components or materials for, or manufacturing of, Fluidigm products; potential product performance and quality issues; intellectual property risks; and competition. Information on these and additional risks and uncertainties and other information affectingFluidigmbusiness and operating results is contained in Fluidigms Annual Report on Form 10-K for the year endedDecember 31, 2019, and in its other filings with theSecurities and Exchange Commission. These forward-looking statements speak only as of the date hereof.Fluidigmdisclaims any obligation to update these forward-looking statements except as may be required by law.

1 Leng, Z., Zhu, R., Hou, W. et al. Transplantation of ACE2 mesenchymal stem cells improves the outcome of patients with COVID-19 pneumonia. Aging and Disease 11 (2020): 216228.

Contacts:

Media:Mark SpearmanSenior Director, Corporate Communications650 243 6621mark.spearman@fluidigm.com

Investors:Agnes LeeVice President, Investor Relations650 416 7423agnes.lee@fluidigm.com

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Fluidigm CyTOF Technology Used to Evaluate Stem Cell Therapy as a Potential Treatment for COVID-19 Pneumonia - Yahoo Finance

Citius Signs Exclusive Option with Novellus to License Novel Stem-Cell Therapy for Acute Respiratory Distress Syndrome (ARDS) Associated with COVID-19…

By Stell Cell Research

CRANFORD, N.J., April 1, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today signed an exclusive six-month option agreement to in-license a stem-cell therapy for acute respiratory distress syndrome (ARDS) from a subsidiary of Novellus, Inc., a preclinical-stage biotechnology company based in Cambridge, MA.

Novellus's patented process uses its exclusive non-immunogenic synthetic messenger ribonucleic acid (mRNA) molecules to create induced pluripotent stem cells (iPSCs) that, in turn, generate mesenchymal stem cells (MSCs) with superior immunomodulatory properties. MSCs have been shown to be safe in over 900 clinical trials and to be safe and effective in treating a number of inflammatory diseases, including ARDS.

"ARDS is the most common cause of respiratory failure and mortality in COVID-19 patients. Currently, there is no proven treatment for ARDS. Literature supports the use of counter-inflammatory MSCs for ARDS, and papers published in China have shown that at least seven COVID-19 patients with ARDS responded to MSC therapy. Clearly this is an avenue that shows promise and should be pursued as a potential treatment for ARDS. We believe Novellus is at the forefront of creating allogeneic, iPSC-derived MSCs. These cells have the potential to overcome the limitations of MSCs derived from adult donors, which are telomere shortened and introduce variability into the manufacturing process," said Citius Chief Executive Officer Myron Holubiak.

Novellus Chief Science Officer Matt Angel, PhD, stated, "Using our mRNA-based cell-reprogramming technology, Novellus can provide a near-unlimited supply of MSCs for treating patients with ARDS, including those critically ill from COVID-19. These will be allogeneic ('off-the-shelf') cells that in vitro have demonstrated much greater expansion potential and much higher immunomodulatory protein expression than donor-derived MSCs. We are excited to employ our technology to such an urgent medical crisis and believe that our MSCs represent an ideal source of cells to be used in this extremely important development effort."

Holubiak added, "No effective pharmacotherapy for ARDS exists, and ARDS-related morbidity and mortality are high. MSCs have been studied in the treatment of lung injury, and we aim to build upon this work with Novellus's iPSC-derived MSCs to improve the immunomodulatory response in humans. We have assembled a team of experts who are dedicated to advancing this project to an Investigational New Drug (IND) application as quickly as possible."

About ARDSAcute respiratory distress syndrome (ARDS) is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. ARDS is a rapidly progressive disease that occurs in critically ill patients most notably now in those diagnosed with COVID-19. ARDS affects approximately 200,000 patients per year in the U.S., exclusive of the current COVID-19 pandemic, and has a 30% to 50% mortality rate. ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease). Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain, particularly while inhaling, and bluish skin coloration. Among those who survive ARDS, a decreased quality of life is relatively common.

About Citius Pharmaceuticals, Inc.Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care. For more information, please visit http://www.citiuspharma.com.

About Novellus, Inc.Novellus is a pre-clinical stage biotechnology company developing engineered cellular medicines using its non-immunogenic mRNA, nucleic-acid delivery, gene editing, and cell reprogramming technologies. Novellus is privately held and is headquartered in Cambridge, MA. For more information, please visit http://www.novellus-inc.com.

Safe HarborThis press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition, and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: the risk of successfully negotiating a license agreement with Novellus within the option period; our need for substantial additional funds; the estimated markets for our product candidates, including those for ARDS, and the acceptance thereof by any market; risks associated with conducting trials for our product candidates, including those expected to be required for any treatment for ARDS and our Phase III trial for Mino-Lok; risks relating to the results of research and development activities; risks associated with developing our product candidates, including any licensed from Novellus, including that preclinical results may not be predictive of clinical results and our ability to file an IND for such candidates; uncertainties relating to preclinical and clinical testing; the early stage of products under development; risks related to our growth strategy; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; our ability to identify, acquire, close, and integrate product candidates and companies successfully and on a timely basis; our ability to attract, integrate, and retain key personnel; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions, or circumstances on which any such statement is based, except as required by law.

Contact:Andrew ScottVice President, Corporate Development(O) 908-967-6677ascott@citiuspharma.com

View original content:http://www.prnewswire.com/news-releases/citius-signs-exclusive-option-with-novellus-to-license-novel-stem-cell-therapy-for-acute-respiratory-distress-syndrome-ards-associated-with-covid-19-301033034.html

SOURCE Citius Pharmaceuticals, Inc.

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Citius Signs Exclusive Option with Novellus to License Novel Stem-Cell Therapy for Acute Respiratory Distress Syndrome (ARDS) Associated with COVID-19...

Cellect Biotechnology Reports Fourth Quarter and Full Year 2019 Results – Yahoo Finance

By Stell Cell Research

Achieved Primary Investigational New Drug (IND) Approval in the U.S.; Positioned to Commence Patient Enrollment

Maintained Clinical Progress in Israel and Nearing Completion of Phase 1/2 Trial

Strategic Commercial Agreement with Canndoc Anticipated to Generate Significant Revenue; Closing of Merger Transaction Progressing as Planned

TEL AVIV, Israel, April 3, 2020 /PRNewswire/ -- Cellect Biotechnology Ltd. (Nasdaq: APOP), a developer of a novel stem cell production technology, today announced operating and financial results for the fourth quarter and full year ended December 31, 2019.

"We achieved a number of strategic priorities in 2019, including the IND approval to commence our first-ever trial in the U.S.," commented Dr. Shai Yarkoni, Chief Executive Officer."We plan to begin enrolling patients for this trial and completing the trial in Israel when the COVID-19 pandemic is mitigated. While these near-term events are value-enhancers, I believe that our recently announced prospective partnership with Canndoc could be a game-changer for Cellect and change our growth trajectory. It has the potential to significantly enhance our short and long term business prospects and shareholder value. As a player in the fast-growing pain management market, we would anticipate significant revenue opportunities already this year."

Recent Strategic Development

As previously announced, on March 4, 2020, the Company entered into a commercial binding Letter Of Intent (LOI) with Canndoc Ltd, a leading pharma grade medical cannabis pioneer and a wholly owned subsidiary of publicly-traded Intercure Ltd. (TASE: INCR),to acquire from Canndoc all rights to the use and sell Canndoc products for the reduction of opioid usage, including accumulated data, as well as on-going and pipeline of clinical trials. This commercial arrangement is subject to negotiation and approval by each company's board of directors and definitive agreements.

Additionally, the two companies signed a non-binding LOI for a full merger. Under preliminary details, Cellect will acquire from Intercure all of Canndoc outstanding shares, in exchange for additional Cellect ADRs to be in total ~95% (~93% on a fully diluted basis) of the merged company. The proposed merger is subject to independent valuation of both companies, fairness opinion by a third party, negotiation of a definitive agreement, approval of the agreement by the Company's Board of Directors and shareholders, internal approvals by Canndoc and Intercure, and customary closing conditions, including the approval of the IMCA (Israeli Medical Cannabis Agency). Upon the closing of the merger, Cellect and Canndoc will aim to fulfill all of the requirements to ensure the Company's ADRs and warrants continue trading on the Nasdaq Stock Market (Nasdaq) and, for this purpose, Intercure would commit to invest a cash sum of at least $3.0 million in any public offering that is undertaken by the Company, at a price of not less than $4.50 per ADR.

Based on the progress to date, the Company continues to expect the commercial and merger transactions will close in the second quarter of 2020.

Additional Operating Highlights:

Clinical Progress Update:

Due to the ongoing COVID-19 pandemic, the Company is experiencing clinical disruption such as:

The Company continues to take all the necessary precautions advised by global health officials to ensure the health and safety of its employees and partners. The Company is unaware of any impact on employees from pandemic related exposure or illness and is continuing to perform in-house research, including in the opioid/pain management area.

Fourth Quarter and Full Year 2019 Financial Results:

Balance Sheet Highlights:

For the convenience of the reader, the amounts have been translated from NIS into U.S. dollars, at the representative rate of exchange on December 31, 2019 (U.S. $1 = NIS 3.456).

About Cellect Biotechnology Ltd.

Cellect Biotechnology (NASDAQ: APOP) has developed a breakthrough technology, for the selection of stem cells from any given tissue, that aims to improve a variety of stem cell-based therapies.

The Company's technology is expected to provide researchers, clinical community and pharma companies with the tools to rapidly isolate stem cells in quantity and quality allowing stem cell-based treatments and procedures in a wide variety of applications in regenerative medicine. The Company's current clinical trial is aimed at bone marrow transplantations in cancer treatment.

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Forward Looking Statements

This press release contains forward-looking statements about the Company's expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. For example, forward-looking statements are used in this press release when we discuss Cellect's intent regarding the future potential of Cellect's technology. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the Company's history of losses and needs for additional capital to fund its operations and its inability to obtain additional capital on acceptable terms, or at all; the Company's ability to continue as a going concern; uncertainties of cash flows and inability to meet working capital needs; the Company's ability to obtain regulatory approvals; the Company's ability to obtain favorable pre-clinical and clinical trial results; the Company's technology may not be validated and its methods may not be accepted by the scientific community; difficulties enrolling patients in the Company's clinical trials; the ability to timely source adequate supply of FasL; risks resulting from unforeseen side effects; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations; the scope of protection the Company is able to establish and maintain for intellectual property rights and its ability to operate its business without infringing the intellectual property rights of others; competitive companies, technologies and the Company's industry; unforeseen scientific difficulties may develop with the Company's technology; and the Company's ability to retain or attract key employees whose knowledge is essential to the development of its products. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in Cellect Biotechnology Ltd.'s Annual Report on Form 20-F for the fiscal year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, http://www.sec.gov, and in the Company's periodic filings with the SEC.

Cellect Biotechnology Ltd

Consolidated Statement of Operation

Convenience

translation

Twelve months

ended

Twelve months ended

Three months ended

December 31,

December 31,

December 31,

2019

2019

2018

2019

2018

Unaudited

Audited

Audited

Unaudited

Unaudited

U.S. dollars

NIS

(In thousands, except share and pershare data)

Research and development expenses

3,508

12,122

13,513

2,571

4,040

General and administrative expenses

2,954

10,210

15,734

2,378

4,733

Operating loss

6,462

22,332

29,247

4,949

8,773

Financial expenses (income) due towarrants exercisable into ADS

(2,032)

(7,022)

(7,719)

998

(4,784)

Other financial expenses (income), net

433

1,498

(1,415)

129

(238)

Total comprehensive loss

4,863

16,808

20,113

6,076

3,751

Loss per share:

Basic and diluted loss per share

0.023

0.079

0.155

0.027

0.029

Weighted average number of sharesoutstanding used to compute basic anddiluted loss per share

212,642,505

212,6432,505

129,426,091

224,087,799

130,274,953

Cellect Biotechnology Ltd

Consolidated Balance Sheet Data

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Cellect Biotechnology Reports Fourth Quarter and Full Year 2019 Results - Yahoo Finance

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