Stem Cell Clinic

First Stem Cell Clinical Trial for Protection Against COVID-19 Approved by FDA – HospiMedica

The FDA has approved a Phase II clinical trial evaluating efficacy and safety of Hope Biosciences (Sugar Land, TX, USA) autologous, adipose-derived mesenchymal stem cells (HB-adMSCs) to provide immune support against COVID-19. MSCs are well-known for their immunomodulatory and regenerative potential. In a recent Phase I/II clinical trial for rheumatoid arthritis, results appeared to show that HB-adMSCs were safe and effective in attenuating systemic inflammation. In COVID-19 patients, inflammation is a driving force behind disease progression, and it is critical to regulate the immune system as early as possible.

This Phase II study is a single arm, non-randomized study that is expected to enroll 75 participants that are either 50 years of age, have preexisting health conditions, or are at high-exposure risk. The studys primary objective is to determine the efficacy of HB-adMSCs to prepare the immune system so that it is better able to fight the virus, should one become infected. Hope anticipates that this pretreatment will limit the progression and severity of COVID-19, ultimately keeping patients out of the hospital and off of mechanical ventilation. HB-adMSCs are administered via five intravenous infusions over a fourteen-week period and follow-up evaluations through six months. All participants will be monitored for changes in health status, including immune cell levels, inflammatory markers, and requirements for supplemental care or hospitalization.

This is the first of three New Drug Applications (INDs), related to COVID-19, that Hope has filed with FDA. This initial protocol is specifically designed for patients who already have their own stem cells banked with the company. The next two protocols will utilize a donor cell source that will aim in protecting against COVID-19 for those at high risk (patients and frontline workers) and treating hospitalized patients.

This study will utilize our proprietary core technology to deliver high quality, pure mesenchymal stem cells with standardized doses and multiple treatments. Our novel technology allows us to overcome the burdens of traditional cell therapy, such as inability to make enough cells to make a significant impact. We can produce, on-demand, over 1,000 highly concentrated HB-adMSC treatments from a single tablespoon of the patients own fat tissue. Most people who have been severely affected by COVID-19 had preexisting conditions. We are pretreating participants who are at higher risk of developing severe COVID-19, with the belief that we can prepare their immune systems, giving them their best chance to fight the virus said Donna Chang, President and CEO of Hope Biosciences.

Our ultimate goal is to prevent anyone from needing mechanical ventilation. We believe that interceding early in the inflammatory process will give us the best possible outcome. Treating the disease is very important but if we have a chance to prevent the condition, we must explore all options. We appreciate the FDAs willingness to take this groundbreaking approach at such a critical time for our nation added Chang.

Related Links:Hope Biosciences

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Moving toward Nonchemotherapy-Based Approaches in Follicular Lymphoma – Cancer Network

Nonchemotherapy-based approaches, including PI3K inhibitors and a more widespread use of allogeneic stem cell transplant, are being explored as treatments for patients with follicular lymphoma, according to Michael L. Grossbard, MD, who added that CAR T-cell therapy is also being evaluated.

As time has gone by, we have tried to move more toward nonchemotherapy brute force approaches to managing follicular lymphoma, said Grossbard, a professor in the Department of Medicine, chief of the Hematology and Medical Oncology Inpatient Service at Tisch Hospital, NYU Langone Healths Perlmutter Cancer Center.

Grossbard, who is also section chief of Hematology at NYU Langone Healths Perlmutter Cancer Center, spoke withOncLive,CancerNetworks sister publication, about these recent developments in the field of follicular lymphoma.

Follicular lymphoma is easy to get into remission with a lot of the new therapies we have, but there is a continuous period of relapse. Patients are not cured with their initial therapy Grossbard explained. Maintenance rituximab (Rituxan) is very helpful because you can use a targeted monoclonal antibody to prolong remissions, which may not have an impact on long-term survival, but prolonging remissions for patients is really important. For a patient, not having disease means a lotemotionally and psychologicallyin terms of quality of life.

According to Grossbard, minimal residual disease (MRD) may help measure the length of remission for a patient; however, there are no studies in follicular lymphoma that currently show that achievement of MRD is critical.

There are a lot of studies that have looked at MRD in follicular lymphoma. Some of those studies go back more than 20 years, which originally showed that the only modality we had to get patients to an MRD-negative state was transplant, said Grossbard. Now, with rituximab and other targeted therapies, we can actually achieve that MRD-negative state with more minimalist approaches.

Another treatment option that Grossbard highlighted were PI3K inhibitors, which are yet another targeted therapy for follicular lymphomas.

We understand more about B cells gone awry, which are the essence of what lymphoma is. The B-cell receptor pathway is triggered by the number of enzymes in a cascade, Grossbard explained. One of those [enzymes] is PI3K, and by blocking that particular enzyme, we can block the growth and proliferation of B cells and cause the killing of lymphoma cells.

However, in order to determine which type of PI3K inhibitor a patient should receive, Grossbard indicated that there are no clear guidelines to be followed, as it depends on personal experience and comfort with the drugs. He recommends becoming familiar with 1 or more of them in order to see where they fit into a patients treatment course.

For patients with heavily pretreated follicular lymphomas, Grossbard indicated that allogeneic transplant opens an option for potential cure, even in later stages and those with more advanced and refractory disease. However, this therapy option is typically not recommended unless a patient has been extensively pretreated.

Patients who have been through multiple chemotherapy regimens, multiple biological therapy regimens, and still have a good performance status and a tolerable amount of comorbid disease would fall into that sweet spot of considering allogeneic stem cell transplant, said Grossbard. Still, even though we do a lot better with managing toxicities than we used to, there are significant potential adverse events of graft-versus-host disease and other complications of allogenic transplant.

When asked about the status of venetoclax (Venclexta) in follicular lymphoma, a BCL2 inhibitor, Grossbard suggested that there is still a lot that is unknown. Venetoclax is currently approved for use in chronic lymphocytic leukemia, small lymphocytic lymphoma, and acute myeloid leukemia.

In theory, venetoclax should be a marvelous drug for follicular lymphoma, but the response rates in follicular lymphoma with single-agent venetoclax have been a little more disappointing than we would have anticipated, Grossbard said. Venetoclaxs place in follicular lymphoma still remains to be defined.

This article was adapted from an article that originally appeared on OncLive, titled Follicular Lymphoma Moves Toward Chemo-Free Regimens.

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Moving toward Nonchemotherapy-Based Approaches in Follicular Lymphoma - Cancer Network

Seneca Biopharma Announces Results of Meeting with FDA Regarding the Design of Phase 3 Trial for NSI-566 in ALS – P&T Community

GERMANTOWN, Md., April 9, 2020 /PRNewswire/ -- Seneca Biopharma, Inc. (Nasdaq: SNCA), a clinical-stage biopharmaceutical company focused on developing novel treatments for diseases of high unmet medical need, today announced that the company held a Type C meeting with the Office of Tissues and Advanced Therapies at the FDA on March 10, 2020 to discuss future clinical development plans for NSI-566, the company's leading neural stem cell therapy candidate, for the treatment of patients with amyotrophic lateral sclerosis (ALS). As a result of the discussion and feedback received from the FDA, Seneca believes that the existing phase 1 and 2 trial results support moving into a phase 3 clinical study for ALS.

"This represents a major step forward in getting our potentially beneficial therapy to patients who suffer from this devastating disease," said David Recker, M.D., Chief Medical Officer for Seneca. "We received significant guidance from FDA regarding an acceptable trial design and are in the process of developing the protocol for further review."

"We are very pleased with the outcome of the discussions," said Dr. Ken Carter, Executive Chairman of Seneca. "We look forward to working closely with the Agency on finalizing the design of a Phase 3 trial for this devastating disease."

NSI-566 has received orphan drug designation in the US for the treatment of ALS. Orphan drug designation offers the sponsor various incentives, including tax credits for qualified clinical testing and extended marketing exclusivity.

About ALS

ALS is a universally fatal disorder that causes progressive paralysis and eventually death from respiratory failure. Though it is rare, ALS is the most common form of motor neuron disease, with approximately 6,000 new cases diagnosed every year in the US. In 2018 the Centers for Disease Control and Prevention reported that there were between 16,000 and 17,000 individuals in the US with ALS.

About Seneca Biopharma, Inc.

Seneca Biopharma, Inc., is a clinical-stage biopharmaceutical company developing novel treatments for diseases of high unmet medical need. The Company is in the process of transforming the organization through the acquisition or in-licensing of new science and technologies, to develop with the goal of providing meaningful therapies for patients.

NSI-566 is a stem cell therapy being tested for treatment of paralysis in stroke, ALS, and chronic spinal cord injury (cSCI).

Cautionary Statement Regarding Forward Looking Information:

This news release contains "forward-looking statements" made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements relate to future, not past, events and may often be identified by words such as "expect," "anticipate," "intend," "plan," "believe," "seek" or "will." Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Specific risks and uncertainties that could cause our actual results to differ materially from those expressed in our forward-looking statements include risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Seneca's periodic reports, including its Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission (SEC), and in other reports filed with the SEC. We do not assume any obligation to update any forward-looking statements.

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Hibiscus Bioventures josh@hibiscusbio.com

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Immunotherapy After Chemotherapy Improves Outcomes in Metastatic Bladder Cancer – Curetoday.com

Using immunotherapy earlier, immediately after the conclusion of chemotherapy to treat metastatic bladder cancer, can delay the time until disease progression.

After completing chemotherapy, patients in the phase 2 study who took Keytruda (pembrolizumab) experienced no disease progression for 5.4 months versus 3 months for those who took placebo. In addition, the patients in the Keytruda group survived for a median 22 months compared with a median 18.7 months in the placebo group.Serious and severe side effects were more common in the immunotherapy group.

The study was published April 9, 2020 in the Journal of Clinical Oncology by Dr. Matthew Galsky, director of genitourinary medical oncology at Mount Sinai, in New York, and his colleagues at institutions across the country.

Bladder cancer becomes metastatic when it spreads to parts of the body that are far from where it developed, such as the lungs, liver, bones or other organs. For decades, the standard treatment for bladder cancer at this stage has been platinum-based chemotherapy followed by observation until the disease progresses. Since immunotherapy has proven effective in treating recurrences of metastatic bladder cancer, researchers wanted to establish whether using it immediately after chemotherapy would improve outcomes both in those who later took immunotherapy again to treat recurrence and in patients who never took another therapy. Giving immunotherapy under these circumstances is a strategy known as switch maintenance.

Between 2015 and 2018, the researchers treated 53 adults who had urothelial carcinoma the most common type of bladder cancer with placebo after they completed chemotherapy, mimicking the current standard of care. Meanwhile, 55 other adults with the disease received Keytruda starting two to six weeks after they finished chemotherapy.

Keytruda is part of a class of drugs called checkpoint inhibitors that interfere with the activity of proteins whose job is to keep the immune system in check. This frees up the immune system to better recognize and fight cancer.

During the study, participants were not told whether they were receiving Keytruda or a placebo in IV treatments every three weeks for 24 months, but those whose disease progressed while taking placebo were invited to switch to the Keytruda group. All the patients were checked for disease progression with imaging after every four cycles.Patients eligible to participate had a disease that was either stable or improved after chemotherapy. They were not eligible if cancer had spread to their brains or if they had used immunosuppressive drugs long-term or had previously been treated with a checkpoint inhibitor. The median age of participants was mid- to late 60s, and the majority were men and white.

The researchers findings of the length of time until disease progression were statistically significant, meaning that they were unlikely to be due to chance, but their results demonstrating lengthened life did not meet that standard. However, the researchers called both trends favorable.

The researchers found that 9% of the patients taking Keytruda experienced a complete response to therapy, meaning they had no remaining detectable cancer. No patients taking placebo had a complete response.

The researchers also reported that the objective response rate (the proportion of patients who experienced a prespecified amount of tumor reduction) was 23% with Keytruda versus 10% with placebo. Patients who were cancer-free after chemotherapy were not included in objective response rate calculations.

While tumors that express a lot of the protein programmed death ligand-1, more commonly referred to as PD-L1, often respond especially well to checkpoint inhibitors, that characteristic did not make a difference in patients outcomes in this study.

Serious and severe side effects that emerged during treatment affected 59% of the patients receiving Keytruda and 38% of the patients receiving placebo, the researchers reported. In the Keytruda group, there was one death from a treatment-related side effect, hepatitis, and 20% of patients initially assigned to that group experienced immune system-related side effects that required treatment with steroids. The largest proportion of side effects experienced during the study were serious, and they included anemia, hypertension, fatigue, difficulty breathing, urinary tract infection and liver problems.

Other recent research supports the finding that switch maintenance with a checkpoint inhibitor can be beneficial to patients in this population, the authors noted. They pointed out that a recent phase 3 trial found a survival benefit with this strategy, and that other trials are investigating even earlier use of immunotherapy in these patients, giving it along with chemotherapy and then continuing it afterward.

Ultimately, the outcomes of the several pending randomized trials will together shape the near-term landscape of first-line treatment for metastatic urothelial cancer, a disease state characterized by a paucity of advances in decades, the researchers wrote.

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Immunotherapy After Chemotherapy Improves Outcomes in Metastatic Bladder Cancer - Curetoday.com

Celularity Expands Strategic Collaboration with United Therapeutics Corporation to COVID-19 Infection and Acute Respiratory Distress Syndrome – Yahoo…

- The expanded strategic collaboration includes the use of Celularity's proprietary CYNK-001 for treatment of SARS-CoV-2 virus, which causes COVID-19 and Acute Respiratory Distress Syndrome

WARREN, N.J., April 9, 2020 /PRNewswire/ --Celularity Inc. ("Celularity" or the "Company"), a clinical-stage company developing allogeneic cellular therapies from human placentas, today announced the expansion of its existing collaborative license agreement with United Therapeutics Corporation's (Nasdaq: UTHR) wholly-owned subsidiary, Lung Biotechnology PBC, to include the treatment of COVID-19 and Acute Respiratory Distress Syndrome (ARDS).

(PRNewsfoto/Celularity, Inc.)

This announcement builds on recent pioneering work by Celularity for the use of its proprietary CYNK-001 for the treatment of the SARS-CoV-2 virus that causes the coronavirus disease, COVID-19, and extends this application of the technology to ARDS. The U.S. Food and Drug Administration recently cleared Celularity's investigational new drug application (IND 019650) to evaluate CYNK-001's safety, tolerability, and efficacy for the treatment of COVID-19.

ARDS, the most devastating complication of COVID-19, is a serious inflammatory lung injury that causes hypoxemia, or below-normal oxygen level in the blood. Hypoxemia can lead to multi-organ system failure and death. Recent findings indicate that ARDS may develop in as many as 17-29% of COVID-19 patients who are hospitalized with pneumonia.

Celularity founder and Chief Executive Officer, Dr. Robert Hariri, said, "This promising, novel approach to treating COVID-19 and the pulmonary complications associated with this infection may unlock a powerful new therapeutic option for patients. The exceptional expertise in pulmonary disease, cellular medicine, and manufacturing makes this strategic collaboration particularly well suited to tackle this urgent, global medical crisis."

Under the amended collaborative agreement, Celularity will seek regulatory approval for CYNK-001 in COVID-19, and Lung Biotechnology will seek regulatory approval for CYNK-001 in ARDS. Lung Biotechnology has global rights under the amended collaborative agreement to commercialize CYNK-001 in COVID-19 and ARDS. The collaboration will be governed by a Joint Steering Committee to oversee development and commercialization activities. Financial terms were not disclosed.

Celularity's CYNK-001 is the only cryopreserved allogeneic, off-the-shelf Natural Killer (NK) cell therapy being developed from placental hematopoietic stem cells and is being investigated as a potential treatment option for various hematologic cancers and solid tumors, and is the first cell therapy granted an IND to treat COVID-19. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and virally infected cells and interacting with adaptive immunity. CYNK-001 cells derived from the postpartum placenta have been shown to be well-tolerated in early clinical trials and are currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and glioblastoma multiforme (GBM).

Media and Investor RelationsMedia Contact:Factory PRcelularity@factorypr.com

Investor Relations Contact:John R. Haines, Executive Vice Presidentjohn.haines@celularity.com

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About Celularity: Celularity, headquartered in Warren, N.J., is a clinical-stage cell therapeutics company delivering transformative allogeneic cellular therapies derived from the postpartum human placenta. Using proprietary technology in combination with its IMPACT platform, Celularity is the only company harnessing the purity and versatility of placental-derived cells to develop and manufacture innovative and highly scalable off-the-shelf treatments for patients with cancer, inflammatory, infectious, and age-related diseases. To learn more, please visit http://www.celularity.com.

Forward-Looking Statements: This press release contains forward-looking statements. These forward-looking statements are based on expectations and are subject to certain factors, risks, and uncertainties that may cause actual results, the outcome of events, timing and performance to differ materially from those expressed or implied by such statements. The information contained in this press release is believed to be current as of the date of the original issue. Celularity expressly disclaims 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 with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

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UCSD To Advance Stem Cell Therapies in New Space Station Lab – Technology Networks

A three-year, nearly $5 million award from NASA will allow researchers at the Sanford Stem Cell Clinical Center at UC San Diego Health, Sanford Consortium for Regenerative Medicine and their partners at Space Tango to develop a new integrated space stem cell orbital research laboratory within the International Space Station (ISS) and launch three collaborative research projects within it.Stem cells self-renew, generating more stem cells, and specialize into tissue-specific cells, such as blood, brain and liver cells, making them ideal for biological studies far from Earths resources. The goal of the new effort is to leverage microgravity and these unique properties of stem cells to better understand how space flight affects the human body. The studies will also inform how aging, degenerative diseases, cancers and other conditions develop in a setting with increased exposure to ionizing radiation and pro-inflammatory factors. The findings from these studies may speed the development of new therapeutics for a broad array of degenerative diseases on Earth.

We envision that the next thriving ecosystem of commercial stem cell companies, the next nexus for biotechnology, could be created 250 miles overhead by the establishment of these capabilities on the ISS, said Catriona Jamieson, MD, PhD, co-principal investigator of the award and Koman Family Presidential Endowed Chair in Cancer Research, deputy director of Moores Cancer Center, director of the Sanford Stem Cell Clinical Center and director of the CIRM Alpha Stem Cell Clinic at UC San Diego Health.

The projects first flight to the ISS is planned for mid-2021. The ISS stem cell lab is expected to be fully operational and self-sustaining by 2025.

With hardware designed by Space Tango, a developer of fully automated, remote-controlled systems for research and manufacturing on orbit, initial projects in the new lab will include investigations of:Blood cancers and immune reactivation syndromes, led by Jamieson, who is also a member of the Sanford Consortium for Regenerative Medicine, and Sheldon Morris, MD, MPH, clinical professor of family medicine and public health and infectious diseases at UC San Diego School of Medicine.In whats known as the NASA Twins Study, investigators around the nation assessed identical twin astronauts Scott and Mark Kelly. Scott flew aboard the ISS for 342 days in 2015 and 2016, while his identical twin brother, Mark, remained on Earth. In a paper published in Science in early 2019, researchers, including UC San Diego School of Medicines Brinda Rana, PhD, described the many ways Scotts body differed from Marks due to his time spent in microgravity, including signs of pre-cancer.

In the new ISS lab, Jamieson and Morris will use stem cell-derived blood and immune cells to look for biomarkers tell-tale molecular changes as cancer develops and immune cells malfunction in microgravity. They will also work with experts in the Jacobs School of Engineering at UC San Diego and Space Tango to build special microscopes and bioreactors that fit the ISS lab space and transmit images to Earth in near real-time.

If we can find early predictors of cancer progression on the ISS, we are ideally positioned to rapidly translate them into clinical trials in our Sanford Stem Cell Clinical Center back on Earth, Jamieson said.Brain stem cell regeneration and repair, led by Alysson R. Muotri, PhD, professor of pediatrics and cellular and molecular medicine and director of the Stem Cell Program at UC San Diego School of Medicine and a member of the Sanford Consortium for Regenerative Medicine, and Erik Viirre, MD, PhD, professor of neurosciences and director of the Arthur C. Clarke Center for Human Imagination.This project will build on a previous proof-of concept flight that sent a payload of stem cell-derived human brain organoids to the ISS in 2019. Brain organoids also called mini-brains are 3D cellular models that represent aspects of the human brain in the laboratory. Brain organoids help researchers track human development, unravel the molecular events that lead to disease and test new treatments.

Since their last trip to space, the UC San Diego team has significantly advanced the brain organoids levels of neural network activity electrical impulses that can be recorded by multi-electrode arrays.

All the research models we currently use to study aging in a laboratory dish rely on artificial things, such as increasing oxidative stress or manipulating genes associated with aging, said Muotri, who is also co-principal investigator on the award. Here, were taking a different approach to speed up the aging process and study how it plays a role in developmental diseases and neurodegenerative conditions such as Alzheimers.Liver cell injury and repair, led by David A. Brenner, MD, vice chancellor of health sciences at UC San Diego, and Tatiana Kisseleva, MD, PhD, associate professor of surgery at UC San Diego School of Medicine.On Earth, Brenner and Kisseleva study ailments of the liver, such as liver fibrosis and steatohepatitis, a type of fatty liver disease. Liver diseases can be caused by alcohol use, obesity, viral infection and a number of other factors. They are interested in determining the impact microgravity may have on liver function, which could provide insights into diseases on Earth, as well as potential effects during space travel. In the future, the team may test therapies for steatohepatitis in the new ISS lab, where microgravity mimics aging and can lead to liver cell injury.

These insights may allow us to develop new ways to stop the progression of liver disease and cirrhosis conditions that affect approximately 4.5 million people in the U.S., Brenner said.

Once the ISS stem cell lab is validated, the team said it will replicate the Earth-based Sanford Consortium for Regenerative Medicine, a collaboratory in La Jolla, Calif. that brings together experts from five research institutions: UC San Diego, Scripps Research, Salk Institute for Biological Studies, Sanford Burnham Prebys Medical Discovery Institute and La Jolla Institute for Immunology.

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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UCSD To Advance Stem Cell Therapies in New Space Station Lab - Technology Networks

Convalescent plasma therapy useful in treating COVID-19 – Anadolu Ajans

ANKARA

Apheresis therapy can be widely beneficial in treating patients with the novel coronavirus, the president of the World Apheresis Association said Wednesday.

Speaking on convalescent plasma therapy, Fevzi Altuntas said this therapy is being successfully applied in many scientific areas of therapeutic apheresis in Turkey.

What is apheresis?

Apheresis is a science that deals with the processing of blood outside of the body to cure a disease and obtaining the desired blood component or stem cell or cellular therapy products, Altuntas said.

Apheresis is a treatment method that has been successfully applied in treating a wide range of diseases that concern a lot of disciplines such as blood diseases, nephrology, neurology, intensive care, emergency medicine, microbiology and clinical infection, he said.

Stressing that apheresis therapy is not applied only for plasma production in patients with the coronavirus, he said in the pandemic, apheresis is also applied for removal of the virus, the released cytokines and chemicals, replacing the coagulation proteins consumed and the collection of plasma of people who have recovered from COVID-19 disease for transfer.

Turkey started applying convalescent plasma therapy faster than many developed countries, he said.

"This situation sums up the success that our country has reached in the field of apheresis science."

What is convalescent plasma therapy?

This passive antibody therapy is aimed at transferring antibodies to a person for the purpose of protecting and treating against disease, Altuntas underlined.

The aim of the therapy is to take antibodies from the blood of a person who has recovered from a virus and transfer them to a sick person, he said.

In this way, the virus in the patient is expected to be deactivated.

Process of therapy

Commenting on the process of therapy, Altuntas said all donors must be diagnosed with COVID-19.

Donors should have no complaints and feel good for at least 14 days after recovery, he said, stressing that legally, people between the ages of 18-60 can be donors.

He went on to say that immunized plasmas are collected from individuals who meet these criteria and stored in blood banks.

Product collection in apheresis center

Speaking on how to collect products at an apheresis center, Altuntas said the apheresis process will take an average of 60-80 minutes. Approximately 200-600 cc of plasma will be collected with apheresis devices.

Also, the donor will be kept under surveillance for 15 minutes after the transaction is completed, he said, adding an appointment for a new plasma donation will be made again with the consent of the donor.

What will happen to collected products?

Touching on the process after collecting the products, Altuntas said barcoding will be done by the Turkish Red Crescent, also known as Kizilay, for the collected products.

Barcoded products will be stored at minus 18-25 degrees or below in a separate storage cabinet, he said, adding convalescent plasma will be transplanted to severe and critical COVID-19 patients.

Finally, 200-400 ml of convalescent plasma will be transplanted to selected patients, he said.

"I invite everyone recovering from this disease to become a volunteer plasma donor. This is not only a social responsibility but a national duty.

Our examples of social solidarity such as plasma donation are crucial to overcoming this fight together healthfully," he added.

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Convalescent plasma therapy useful in treating COVID-19 - Anadolu Ajans

Stempeutics partners with Global Consortium of cell therapy companies – BSI bureau

Stempeutics will test its stem cell product Stempeucel for Acute Respiratory Disease Syndrome (ARDS) caused by COVID-19 Pneumonia

Bengaluru based Stempeutics Research, a group company of Manipal Education and Medical Group (MEMG), announced that it has partnered with Global Consortium of cell therapy companies seeking European Commission Funding to Fight Against Corona! (FAC!).

Under this partnership, Stempeutics will export its stem cell product Stempeucel (subject to regulatory approvals) for treating critically ill COVID-19 patients with lung disease. First the product will be clinically tested and upon successful outcomes, it intends to export the product on a regular basis. In this connection it is signing up an alliance with Educell Ltd, Slovenia.

Stempeucel is an allogeneic, off the shelf, pooled mesenchymal stromal cells having antiinflammatory and immune-modulatory properties which prevents the over activation of the immune system. Stempeucel product exhibits a wide range of potent therapeutic properties.

The product exhibits potent immunomodulatory and anti-inflammatory properties which could help in reducing the inflammation caused due to the cytokine storm elicited by the bodys immune cells in response to SARS-CoV-2 (COVID-19) related infection in the lungs. Also, the growth factor, Angiopoietin-1 (Ang-1) is effective in reducing alveolar epithelium permeability in the lung. Hence it is envisaged, Stempeucel will reduce the fatal symptoms of COVID 19 induced pneumonia and its progression to ARDS.

BN Manohar, CEO of Stempeutics said, From the clinical data using Stempeucel in different clinical trialsin other indications it may be postulated that Stempeucel has the potential capability for treating COVID 19 infection. Together with the safety profile observed from DCGI approved clinical trials involving more than 350 patients injected with Stempeucel by different routes of injection, this therapy may help in mitigating the lung tissue damaging effects of COVID 19 infection.

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Stempeutics partners with Global Consortium of cell therapy companies - BSI bureau

DNA Repair Gene-Related CHIP Is a Marker for Worse Outcomes in Patients With Lymphoma – Cancer Therapy Advisor

In contrast to findings from previously conducted retrospective single-centerstudies, results of a study of a large population-based cohort of patients withlymphoma undergoing autologous hematopoietic stem cell (HSC) harvesting showedno independent association between the general presence of clonal hematopoiesisof indeterminate origin (CHIP) and overall survival. These findings werepublished in Leukemia.1

In normal hematopoiesis, a single type of HSC accounts for only a verylow percentage of the overall HSCs present. However, in the case of CHIP, asingle HSC clone can expand to comprise 10% or more of the overall HSCpopulation.2 Specifically, CHIP has often been defined as thepresence of somatic mutations in HSCs at a variant gene frequency of 2% orhigher.3

Although CHIP can occur in individuals without a known hematologicmalignancy, previous retrospective studies of patients with cancer conducted atsingle centers with varying amounts of follow-up have shown worse clinicaloutcomes in those with CHIP compared with patients without this condition.

This large population-based study included data for 565 adult patientsfrom 5 independent national stem cell harvest registries from Denmark whounderwent autologous HSC harvesting between January 1, 2000, and July 1, 2012,followed by high-throughput DNA sequencing of HSC specimens.

Although this was a retrospective analysis, specimen collection andclinical follow-up were performed prospectively. The main aims of this studywas to evaluate the impact of CHIP on survival, as well as the tolerability ofautologous-HSC transplantation (ASCT).

Immediate HSCT was planned for 440 ofthese patients, and only this subgroup was included in the survival analysis. Thepercentages of lymphoma subtypes represented in this subgroup were as follows:diffuse large B-cell lymphoma (DLBCL; 37%), follicular lymphoma (8%), Hodgkinlymphoma (15%), mantle cell lymphoma (19%), peripheral T-cell lymphoma (PTCL;17%) and other lymphoma subtypes (4%).

In the patient subgroup for which immediateHSCT was planned, at least 1 CHIP mutation of any type or DNA repair pathway-relatedCHIP mutation was present in 112 (26%) and 40 patients (9.1%), respectively. Specifically,of the 143 total CHIP mutations identified, 48 (34%) encoded for a regulator ofDNA repair (ie, PPM1D, TP53, RAD21,BRCC3). Other types of CHIP mutations were mostcommonly identified in DNMT3Aand TET2.

At a median follow-up of 9.1 years, the overall group had a 15-yearoverall survival of 40.2%. Although OS was worse in the subgroup with CHIP,these patients were significantly older than thosewithout this condition (P <.0001).No significant difference in OS was found following multivariate analysesadjusting for age and aggressiveness of lymphoma subtype.

Incontrast, median OS was 2.2 years and 9.0 years in inthe subgroup of patients with CHIP mutations in DNA pathway-associated genescompared with those without these CHIP mutations. Multivariateanalyses showed significantly worse late but not early OS for those with these typesof CHIP mutations versus not (P =.00067). However, OS was not significantly different for thosewith common CHIP mutation in nonDNA repair-associated genes compared withthose without CHIP mutations.

Anotherinteresting finding of this study was that patients with CHIP mutations in DNArepair genes had a significantly higher risk of being admitted to an intensivecare unit compared with those without these mutations (P =.035 on multivariate analysis). Furthermore, this finding wasnot observed when the overall subgroups of those with and without any CHIPmutations were compared.

In their concluding remarks, the study authors commented that this information could aid [in] the identification of patients with lymphoma who are susceptible to adverse outcomes after ASCT.

References

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DNA Repair Gene-Related CHIP Is a Marker for Worse Outcomes in Patients With Lymphoma - Cancer Therapy Advisor