The killer is not the virus but the immune response.

The current pandemic is unique not just because it is caused by a new virus that puts everyone at risk, but also because the range of innate immune responses is diverse and unpredictable. In some it is strong enough to kill. In others it is relatively mild.

My research relates to innate immunity. Innate immunity is a persons inborn defense against pathogens that instruct the bodys adaptive immune system to produce antibodies against viruses. Those antibody responses can be later used for developing vaccination approaches. Working in the lab of Nobel laureate Bruce Beutler, I co-authored the paper that explained how the cells that make up the bodys innate immune system recognize pathogens, and how overreacting to them in general could be detrimental to the host. This is especially true in the COVID-19 patients who are overreacting to the virus.

I study inflammatory response and cell death, which are two principal components of the innate response. White blood cells called macrophages use a set of sensors to recognize the pathogen and produce proteins called cytokines, which trigger inflammation and recruit other cells of the innate immune system for help. In addition, macrophages instruct the adaptive immune system to learn about the pathogen and ultimately produce antibodies.

To survive within the host, successful pathogens silence the inflammatory response. They do this by blocking the ability of macrophages to release cytokines and alert the rest of the immune system. To counteract the viruss silencing, infected cells commit suicide, or cell death. Although detrimental at the cellular level, cell death is beneficial at the level of the organism because it stops proliferation of the pathogen.

For example, the pathogen that caused the bubonic plague, which killed half of the human population in Europe between 1347 and 1351, was able to disable, or silence, peoples white blood cells and proliferate in them, ultimately causing the death of the individual. However, in rodents the infection played out differently. Just the infected macrophages of rodents died, thus limiting proliferation of the pathogen in the rodents bodies which enabled them to survive.

The silent response to plague is strikingly different from the violent response to SARS-CoV-2, the virus that causes COVID-19. This suggests that keeping the right balance of innate response is crucial for the survival of COVID-19 patients.

Heres how an overreaction from the immune system can endanger a person fighting off an infection.

Some of the proteins that trigger inflammation, named chemokines, alert other immune cells like neutrophils, which are professional microbe eaters to convene at the site of infections where they can arrive first and digest the pathogen.

Others cytokines such as interleukin 1b, interleukin 6 and tumor necrosis factor guide neutrophils from the blood vessels to the infected tissue. These cytokines can increase heartbeat, elevate body temperature, trigger blood clots that trap the pathogen and stimulate the neurons in the brain to modulate body temperature, fever, weight loss and other physiological responses that have evolved to kill the virus.

When the production of these same cytokines is uncontrolled, immunologists describe the situation as a cytokine storm. During a cytokine storm, the blood vessels widen further (vasolidation), leading to low blood pressure and widespread blood vessel injury. The storm triggers a flood of white blood cells to enter the lungs, which in turn summon more immune cells that target and kill virus-infected cells. The result of this battle is a stew of fluid and dead cells, and subsequent organ failure.

The cytokine storm is a centerpiece of the COVID-19 pathology with devastating consequences for the host.

When the cells fail to terminate the inflammatory response, production of the cytokines make macrophages hyperactive. The hyperactivated macrophages destroy the stem cells in the bone marrow, which leads to anemia. Heightened interleukin 1b results in fever and organ failure. The excessive tumor necrosis factor causes massive death of the cells lining the blood vessels, which become clotted. At some point, the storm becomes unstoppable and irreversible.

One strategy behind the treatments for COVID is, in part, based in part on breaking the vicious cycle of the cytokine storm. This can be done by using antibodies to block the primary mediators of the storm, like IL6, or its receptor, which is present on all cells of the body.

Inhibition of tumor necrosis factor can be achieved with FDA-approved antibody drugs like Remicade or Humira or with a soluble receptor such as Enbrel (originally developed by Bruce Beutler) which binds to tumor necrosis factor and prevents it from triggering inflammation. The global market for tumor necrosis factor inhibitors is US$22 billion.

Drugs that block various cytokines are now in clinical trials to test whether they are effective for stopping the deadly spiral in COVID-19.

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Blocking the deadly cytokine storm is a vital weapon for treating COVID-19 - The Conversation US

Bone Marrow Stem Cells Comments Off on Blocking the deadly cytokine storm is a vital weapon for treating COVID-19 – The Conversation US | May 21st, 2020

Global Cell Therapy Technologies Marketwas valued US$ 12 billion in 2018 and is expected to reach US$ 35 billion by 2026, at CAGR of 12.14 %during forecast period.

The objective of the report is to present comprehensive assessment projections with a suitable set of assumptions and methodology. The report helps in understanding Global Cell Therapy Technologies Market dynamics, structure by identifying and analyzing the market segments and projecting the global market size. Further, the report also focuses on the competitive analysis of key players by product, price, financial position, growth strategies, and regional presence. To understand the market dynamics and by region, the report has covered the PEST analysis by region and key economies across the globe, which are supposed to have an impact on market in forecast period. PORTERs analysis, and SVOR analysis of the market as well as detailed SWOT analysis of key players has been done to analyze their strategies. The report will to address all questions of shareholders to prioritize the efforts and investment in the near future to the emerging segment in the Global Cell Therapy Technologies Market.

REQUEST FOR FREE SAMPLE REPORT:https://www.maximizemarketresearch.com/request-sample//31531/

The report study has analyzed revenue impact of covid-19 pandemic on the sales revenue of market leaders, market followers and disrupters in the report and same is reflected in our analysis.

Global Cell Therapy Technologies Market: Overview

Cell therapy is a transplantation of live human cells to replace or repair damaged tissue and/or cells. With the help of new technologies, limitless imagination, and innovative products, many different types of cells may be used as part of a therapy or treatment for different types of diseases and conditions. Celltherapy technologies plays key role in the practice of medicine such as old fashioned bone marrow transplants is replaced by Hematopoietic stem cell transplantation, capacity of cells in drug discovery. Cell therapy overlap with different therapies like, gene therapy, tissue engineering, cancer vaccines, regenerative medicine, and drug delivery. Establishment of cell banking facilities and production, storage, and characterization of cells are increasing volumetric capabilities of the cell therapy market globally. Initiation of constructive guidelines for cell therapy manufacturing and proven effectiveness of products, these are primary growth stimulants of the market.

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Global Cell Therapy Technologies Market: Drivers and Restraints

The growth of cell therapy technologies market is highly driven by, increasing demand for clinical trials on oncology-oriented cell-based therapy, demand for advanced cell therapy instruments is increasing, owing to its affordability and sustainability, government and private organization , investing more funds in cell-based research therapy for life-style diseases such as diabetes, decrease in prices of stem cell therapies are leading to increased tendency of buyers towards cell therapy, existing companies are collaborating with research institute in order to best fit into regulatory model for cell therapies.Moreover, Healthcare practitioners uses stem cells obtained from bone marrow or blood for treatment of patients with cancer, blood disorders, and immune-related disorders and Development in cell banking facilities and resultant expansion of production, storage, and characterization of cells, these factors will drive the market of cell therapy technologies during forecast period.

On the other hand, the high cost of cell-based research and some ethical issue & legally controversial, are expected to hamper market growth of Cell Therapy Technologies during the forecast period

AJune 2016, there were around 351 companies across the U.S. that were engaged in advertising unauthorized stem cell treatments at their clinics. Such clinics boosted the revenue in this market.in August 2017, the U.S. FDA announced increased enforcement of regulations and oversight of clinics involved in practicing unapproved stem cell therapies. This might hamper the revenue generation during the forecast period; nevertheless, it will allow safe and effective use of stem cell therapies.

Global Cell Therapy Technologies Market: Segmentation Analysis

On the basis of product, the consumables segment had largest market share in 2018 and is expected to drive the cell therapy instruments market during forecast period at XX % CAGR owing to the huge demand for consumables in cell-based experiments and cancer research and increasing number of new product launches and consumables are essential for every step of cell processing. This is further expected to drive their adoption in the market. These factors will boost the market of Cell Therapy Technologies Market in upcoming years.

On the basis of process, the cell processing had largest market share in 2018 and is expected to grow at the highest CAGR during the forecast period owing to in cell processing stage,a use of cell therapy instruments and media at highest rate, mainly in culture media processing. This is a major factor will drive the market share during forecast period.

Global Cell Therapy Technologies Market: Regional Analysis

North America to held largest market share of the cell therapy technologies in 2018 and expected to grow at highest CAGR during forecast period owing to increasing R&D programs in the pharmaceutical and biotechnology industries. North America followed by Europe, Asia Pacific and Rest of the world (Row).Scope of Global Cell Therapy Technologies Market

Global Cell Therapy Technologies Market, by Product

Consumables Equipment Systems & SoftwareGlobal Cell Therapy Technologies Market, by Cell Type

Human Cells Animal CellsGlobal Cell Therapy Technologies Market, by Process Stages

Cell Processing Cell Preservation, Distribution, and Handling Process Monitoring and Quality ControlGlobal Cell Therapy Technologies Market, by End Users

Life Science Research Companies Research InstitutesGlobal Cell Therapy Technologies Market, by Region

North America Europe Asia Pacific Middle East & Africa South AmericaKey players operating in the Global Cell Therapy Technologies Market

Beckman Coulter, Inc. Becton Dickinson and Company GE Healthcare Lonza Merck KGaA MiltenyiBiotec STEMCELL Technologies, Inc. Terumo BCT, Inc. Thermo Fisher Scientific, Inc. Sartorius AG

MAJOR TOC OF THE REPORT

Chapter One: Cell Therapy Technologies Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Cell Therapy Technologies Market Competition, by Players

Chapter Four: Global Cell Therapy Technologies Market Size by Regions

Chapter Five: North America Cell Therapy Technologies Revenue by Countries

Chapter Six: Europe Cell Therapy Technologies Revenue by Countries

Chapter Seven: Asia-Pacific Cell Therapy Technologies Revenue by Countries

Chapter Eight: South America Cell Therapy Technologies Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Cell Therapy Technologies by Countries

Chapter Ten: Global Cell Therapy Technologies Market Segment by Type

Chapter Eleven: Global Cell Therapy Technologies Market Segment by Application

Chapter Twelve: Global Cell Therapy Technologies Market Size Forecast (2019-2026)

Browse Full Report with Facts and Figures of Cell Therapy Technologies Market Report at:https://www.maximizemarketresearch.com/market-report/global-cell-therapy-technologies-market/31531/

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Global Cell Therapy Technologies Market : Industry Analysis and Forecast... - Azizsalon News

Bone Marrow Stem Cells Comments Off on Global Cell Therapy Technologies Market : Industry Analysis and Forecast… – Azizsalon News | May 19th, 2020

MINNEAPOLIS & EL SEGUNDO, Calif.--(BUSINESS WIRE)--Be The Match BioTherapies, an organization offering solutions for companies developing and commercializing cell and gene therapies, and NantKwest (Nasdaq: NK), a next generation, clinical-stage immunotherapy company focused on harnessing the unique power of the immune system using natural killer (NK) cells to treat cancer and infectious diseases, today announced an agreement through which Be The Match BioTherapies is providing donor material for a NantKwest Phase 1b clinical trial to address acute respiratory distress syndrome (ARDS), one of the primary causes of COVID-19 deaths.

The agreement combines Be The Match BioTherapies ability to provide high-quality cellular source material from the worlds largest registry of volunteer donors with NantKwests capabilities in manufacturing off-the-shelf cell therapies. NantKwests allogeneic cell therapy is derived from human bone marrow and designed to treat the ARDS that results from severe COVID-19 cases. The therapy, called BM-Allo.MSC, uses mesenchymal stem cells (MSCs), multipotent progenitor cells known to have immunomodulatory properties, to reduce the lung inflammation associated with ARDS. Similar work in Europe with allogeneic MSC products in patients with COVID-19 and ARDS has demonstrated safety and efficacy in reducing inflammatory processes.

NantKwest recently announced FDA authorization of its investigational new drug (IND) application for BM-Allo.MSC and is moving rapidly to initiate a Phase 1b trial in patients with severe COVID-19. To expedite trial initiation, Be The Match BioTherapies is providing cryopreserved donor stem cell material from the Be The Match BioBank, a program of the National Marrow Donor Program/Be The Match. The accelerated access to material, combined with NantKwests scalable manufacturing processes, will allow for rapid distribution of BM-Allo.MSC to patients in need.

There is an immediate need for COVID-19 therapies across all stages of the disease, including for patients with ARDS, which is one of the most critical conditions caused by COVID-19, said Patrick Soon-Shiong, MD, Chairman and Chief Executive Officer of NantKwest. Thanks to the quality source material provided by Be The Match BioTherapies, we are prepared to rapidly scale manufacturing of this much-needed therapy, potentially saving numerous patients lives.

Through our teams unparalleled ability to identify, source and deliver high-quality donor material we have the opportunity to support the advancement of a cell therapy with potential to change the world. We are proud to partner with NantKwest to support our mission to save lives through cellular therapy and continue to make a difference for critically ill patients around the globe, said Chris McClain, Senior Vice President, Sales and New Business Development at Be The Match BioTherapies.

About Be The Match BioTherapies

Be The Match BioTherapies is the only cell and gene therapy solutions provider with customizable services to support the end-to-end cell therapy supply chain. Backed by the industry-leading experience of the National Marrow Donor Program (NMDP)/Be The Match, and a research partnership with the CIBMTR (Center for International Blood and Marrow Transplant Research), the organization designs solutions that advance the development of cell and gene therapies across the globe.

Be The Match BioTherapies is dedicated to accelerating patient access to life-saving cell and gene therapies by providing high-quality cellular source material from the Be The Match Registry, the worlds largest and most diverse registry of more than 22 million potential blood stem cell donors. Through established relationships with apheresis, marrow collection and transplant centers worldwide, the organization develops, onboards, trains and manages expansive collection networks to advance cell therapies. Be The Match BioTherapies uses proven infrastructure consisting of regulatory compliance and managed logistics experts, as well as cell therapy supply chain case managers to successfully transport and deliver regulatory compliant life-saving therapies across the globe. Through the CIBMTR, Be The Match BioTherapies extends services beyond the cell therapy supply chain to include long-term follow-up tracking for the first two FDA-approved CAR-T therapies.

For more information, visit http://www.BeTheMatchBioTherapies.com or follow Be The Match BioTherapies on LinkedIn or Twitter at @BTMBioTherapies.

About NantKwest

NantKwest (Nasdaq: NK) is an innovative, clinical-stage immunotherapy company focused on harnessing the power of the innate immune system to treat cancer and virally-induced infectious diseases. NantKwest is the leading producer of clinical dose forms of off-the-shelf natural killer (NK) cell therapies. The activated NK cell platform is designed to destroy cancer and virally-infected cells. The safety of these optimized, activated NK cellsas well as their activity against a broad range of cancershas been tested in Phase I clinical trials in Canada and Europe, as well as in multiple Phase I and II clinical trials in the United States. By leveraging an integrated and extensive genomics and transcriptomics discovery and development engine, together with a pipeline of multiple, clinical-stage, immuno-oncology programs, NantKwests goal is to transform medicine by delivering living drugs-in-a-bag and bringing novel NK cell-based therapies to routine clinical care. NantKwest is a member of the NantWorks ecosystem of companies. For more information, please visit http://www.nantkwest.com.

Excerpt from:
Be The Match BioTherapies and NantKwest Announce Collaboration to Accelerate Development of Cell Therapy to Prevent COVID-19 Deaths - Business Wire

Bone Marrow Stem Cells Comments Off on Be The Match BioTherapies and NantKwest Announce Collaboration to Accelerate Development of Cell Therapy to Prevent COVID-19 Deaths – Business Wire | May 19th, 2020

The study is anticipated to consist of approximately thirty patients with potential involvement of the NIH of Mexico in other CytoDyn trials

VANCOUVER, Washington, May 19, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced it will be coordinating with the NIH of Mexico and providing leronlimab for a trial for the severe/critical COVID-19 population in Mexico with the potential to collaborate on further CytoDyn COVID-19 trials.

CytoDyn is currently enrolling a Phase 2b/3 clinical trial for 390 patients, which is a randomized, placebo-controlled with 2:1 ratio (active drug to placebo ratio). CytoDyn is also enrolling a Phase 2 randomized clinical trial with 75 patients in the mild-to-moderate COVID-19 population. CytoDyn has been granted more than sixty emergency Investigational New Drug (eIND) authorizations by the U.S. Food and Drug Administration (FDA) and plans to provide clinical updates for this patient population later in the week.

We look forward to evaluating leronlimab as a treatment option for patients of COVID-19. We have seen the devastation of this disease on the citizens of Mexico and are looking forward to providing effective treatment options to mitigate the devastation of COVID-19, said Dr. Gustavo Reyes Tern, head of the Coordinating Commission of National Institutes of Health and High Specialty Hospitals of Mexico, an organization that coordinates the main institutions of medical care and public research in the country.

The NIH of Mexico is committed to help alleviate human suffering and mortality of Mexican citizens. The Metropolitan Area of the Valley of Mexico has a population of approximately 21.5 million people and the contagious nature of COVID-19 is relentless. We look forward to working with the NIH of Mexico to rapidly commence with the proposed study. We also believe that this study results, along with the ongoing Phase 2 study, could establish a path for quick approval in Mexico for use of leronlimab in COVID-19 patients, said Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn.

About Coronavirus Disease 2019CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) and BLA Submission for the HIV Combination TherapyThe FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

The Company filed its BLA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients with the FDA on April 27, 2020, and submitted additional FDA requested clinical datasets on May 11, 2020. After the BLA submission is deemed completed, the FDA sets a PDUFA goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously assigned by the FDA, and the Company plans to request a priority review for the BLA. A priority review designation means the FDAs goal is to take action on the marketing application within six months of receipt (compared with 10 months under standard review).

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn filed its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients, and submitted additional FDA requested clinical datasets on May 11, 2020. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498dave@redchip.com

Originally posted here:
CytoDyn and the Mexican National Institutes of Health Participate in a Collaborative Study of Leronlimab for the Treatment of Severe/Critical COVID-19...

Bone Marrow Stem Cells Comments Off on CytoDyn and the Mexican National Institutes of Health Participate in a Collaborative Study of Leronlimab for the Treatment of Severe/Critical COVID-19… | May 19th, 2020

18 May 2020

New research, in HIV positive patients being treated for blood cancer, has identified a critical time window after donor stem cell transplantation, during which the expanding donor cells are particularly vulnerable to being infected with HIV.

Patients with HIV who develop blood cancer may require treatment by allogeneic stem cell transplant, using bone marrow stem cells provided by a healthy donor. During a transplant, most of the patient's original immune cells are destroyed, and the immune system and blood cells are restored from the new donor stem cells.

'These results show a weak point that may explain why allogeneic stem cell transplants may not completely remove the virus from the body, despite a drastic reduction in the number of infected cells' saidsenior authorDr Julian Schulze zur Wiesch from the German Centre for Infection Research.

Stem cell transplantation in HIV positive patients has been the only medical intervention found to cure HIV (see BioNews 1039), however in nearly all cases HIV infection persists after transplantation.

In a new study it was discovered that immune cells generated from the donor stem cells are at risk of being infected with HIV during the first few weeks after transplantation.

In this study of 16 HIV positive participants with blood cancer, the researchers show that stem cell transplantation promotes reactivation of the virus within the patient's remaining original immune cells. This leads to some of the new immune cells becoming infected, thus 're-seeding' HIV within the host.

'Additional immunotherapy orgene therapy may be required to achieve ongoing, spontaneous control of HIV infection in people with HIV after allogeneic stem cell transplantation,' said Dr Schulze zur Wiesch.

This research was published in Science Translational Medicine.

Here is the original post:
Critical window for re-infection with HIV after stem cell transplantation - BioNews

Bone Marrow Stem Cells Comments Off on Critical window for re-infection with HIV after stem cell transplantation – BioNews | May 18th, 2020

EL SEGUNDO, Calif.--(BUSINESS WIRE)--NantKwest, Inc. (NASDAQ: NK) today announced it has received authorization from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug application to treat patients with acute respiratory distress syndrome (ARDS) caused by COVID-19 with BM-Allo.MSC, an allogeneic mesenchymal stem cell (MSC) product derived from human bone marrow. NantKwest has entered into an agreement with the National Marrow Donor Program (Be the Match) to provide donor material and has developed automated proprietary methods to expand and generate multiple dose forms utilizing a modular, closed system (GMP-in-a-box) from NantKwest affiliate ImmunityBio, Inc., to expand BM-Allo.MSCs, enabling the scalable manufacture and immediate distribution of cryopreserved BM-Allo.MSC product.

There is an urgent need to develop broadly accessible treatment options for the devastating outcomes seen in the thousands of COVID-19 patients who are facing severe disease with ARDS and cytopathic storm, said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of NantKwest and ImmunityBio. While MSC-derived treatments have shown promise in treating patients with ARDS, including those with COVID-19, the ability to scale production to support the overwhelming patient need has been a challenge. Our proprietary GMP-in-a-Box enables the rapid and scalable manufacture of our fully human BM-Allo.MSC product, overcoming this previous limitation to advance a promising new treatment to those patients who are most in need. Due to our proprietary methods, we are well positioned to rapidly advance BM-Allo.MSC during the current wave of COVID-19, with an anticipated trial initiation in Q2.

BM-Allo.MSC is a bone marrow-derived allogenic MSC product being developed to attenuate the inflammatory processes that drive ARDS in severe COVID-19 patients. MSCs are multipotent progenitor cells that give rise to cell types responsible for tissue repair and may restore effective immune function and contribute to viral clearance. Prior work with allogeneic MSC products in patients with ARDS has shown that such treatment is safe and may reduce key markers of inflammatory processes.

Trial Design

The Phase 1b, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of BM-Allo.MSC versus current supporting care in treating patients with severe disease and requiring ventilator support (IND 019735). The therapeutic will be administered to a total of 45 patients receiving care in the critical care or ICU setting. The primary objectives of the study include overall safety and reduction in time on ventilator. The secondary objective will focus on the efficacy of BM-Allo.MSC in reducing the number of days patients require oxygen, duration of hospitalization, and mortality.

About NantKwest

NantKwest (NASDAQ: NK) is an innovative, clinical-stage immunotherapy company focused on harnessing the power of the innate immune system to treat cancer and virally-induced infectious diseases. NantKwest is the leading producer of clinical dose forms of off-the-shelf natural killer (NK) cell therapies. The activated NK cell platform is designed to destroy cancer and virally-infected cells. The safety of these optimized activated NK cellsas well as their activity against a broad range of cancershas been tested in Phase I clinical trials in Canada and Europe, as well as in multiple Phase I and II clinical trials in the United States. By leveraging an integrated and extensive genomics and transcriptomics discovery and development engine, together with a pipeline of multiple, clinical-stage, immuno-oncology programs, NantKwests goal is to transform medicine by delivering off-the-shelf living drugs-in-a-bag and bringing novel NK cell-based therapies to routine clinical care. NantKwest is a member of the NantWorks ecosystem of companies. For more information, please visit http://www.nantkwest.com

haNK is a registered trademark of NantKwest, Inc.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning or implying that NantKwest will be successful in improving the treatment of cancer and/or Covid-19. Risks and uncertainties related to this endeavor include, but are not limited to, obtaining FDA approval of NantKwests NK cells, as well as other therapeutics, as part of the NANT Cancer Vaccine platform as a cancer treatment and/or Covid-19 treatment.

Forward-looking statements are based on managements current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements.

These and other risks regarding NantKwests business are described in detail in its Securities and Exchange Commission filings, including in NantKwests Quarterly Report on Form 10-Q for the Quarter ended March 31, 2020. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

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NantKwest Announces FDA Authorization of IND Application for Mesenchymal Stem Cell Product for the Treatment of Severe COVID-19 Patients - Business...

Bone Marrow Stem Cells Comments Off on NantKwest Announces FDA Authorization of IND Application for Mesenchymal Stem Cell Product for the Treatment of Severe COVID-19 Patients – Business… | May 18th, 2020

Three arms of this trial will be leronlimab, remdesivir, and leronlimab + remdesivir

VANCOUVER, Washington, May 18, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced it will be submitting a protocol to the U.S. Food and Drug Administration (FDA) for a factorial design trial to compare effectiveness of leronlimab versus remdesivir and in combination with remdesivir for the treatment of COVID-19.

Leronlimab was administered to more than sixty patients with COVID-19 under emergency Investigational New Drug (eINDs) authorizations granted by the FDA. Preliminary results from this patient population led to CytoDyns Phase 2b/3 clinical trial for 390 patients, which is randomized, placebo-controlled with 2:1 ratio (active drug to placebo ratio). CytoDyn has also been granted a Phase 2 randomized clinical trial study in the U.S. for a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. CytoDyn plans to update the public regarding current eIND results later this week.

We believe the randomized head-to-head comparison of leronlimab to remdesivir and in combination will provide answers to the lingering question regarding effective treatment options for patients suffering from COVID-19. We look forward to working both in the United States and with potential international sites to help provide effective treatment options for COVID-19, said Jacob Lalezari, M.D., Chief Science Officer of CytoDyn.

Unfortunately, COVID-19 remains a global public health challenge, and its economic impact continues to devastate the world economy. With a second wave of potential cases threatening to surface in the fall and winter of 2020, it is more important than ever to be sure successful treatment options are available to protect the lives of patients. CytoDyn has assurance from its manufacturer that it will have available over 1 million vials this year and could ramp up production to 2-3 million vials this year alone, said, Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn.

About Coronavirus Disease 2019CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) and BLA Submission for the HIV Combination TherapyThe FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

The Company filed its BLA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients with the FDA on April 27, 2020, and submitted additional FDA requested clinical datasets on May 11, 2020. After the BLA submission is deemed completed, the FDA sets a PDUFA goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously assigned by the FDA, and the Company plans to request a priority review for the BLA. A priority review designation means the FDAs goal is to take action on the marketing application within six months of receipt (compared with 10 months under standard review).

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn filed its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients, and submitted additional FDA requested clinical datasets on May 11, 2020. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498dave@redchip.com

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CytoDyn to Prepare a Phase 3 Protocol to Submit to the FDA for a Three-Arm Comparative and Combination Trial of Leronlimab and Remdesivir -...

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MIKE TYSON has revealed he was injected with nearly-translucent blood in his bid to make a comeback... and the former heavyweight champ said it made him feel "weird".

The 53-year-old - who retired from boxing in 2005 - has announced his intention to dust off the gloves and return to compete in exhibition bouts.

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His return to action has been aided by stem-cell research therapy, that has left him feeling like a "different person".

He said: "You know what I had done? I had stem-cell research therapy.

"I feel like a different person but I can't comprehend why I feel this way. It's really wild what scientists can do."

Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition that usually takes the form of a bone marrow transplantation.

In a recent interview with rapper LL Cool J on the Rock the Bells Radio show on SiriusXM, Tyson opened up on the effects the treatment has had on him.

Commenting on the mental aspect of training for a fight for the first time in 15 years, he said: "My mind wouldnt belong to me.

"My mind would belong to somebody that disliked me enough to break my soul, and I would give them my mind for that period of time.

"Six weeks of this and Id be in the best shape Ive ever dreamed of being in. As a matter of fact, Im going through that process right now. And you know what else I did, I did stem-cell research."

Tyson was then asked whether that meant if his white blood had been spun and then put back in, to which he replied: "Yes. As they took the blood it was red and when it came back it was almost transfluid (sic).

"I could almost see through the blood, and then they injected it in me.

"And Ive been weird ever since, Ive got to get balanced now."

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WHAT IS STEM CELL TREATMENT USED FOR?

Stem cell transplants are carried out when bone marrow is damaged or isnt able to produce healthy blood cells.

It can also be used to replace damaged blood cells as the result of intensive cancer treatment.

Here are conditions that stem cell transplants can be used to treat:

Iron Mike has been called out by former rival Evander Holyfield to complete their trilogy following their two meetings in 1990s.

And his unusual methods for getting back in shape seem to be working.

Tyson is looking in incredible condition as he uploaded a clip of himself that showed off his ferocious power and speed.

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Mike Tyson reveals doctors gave him translucent blood injection that left him feeling weird during stem cel - The Sun

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PUBLISHED: 06:30 16 May 2020 | UPDATED: 13:58 16 May 2020

James Barham was diagnosed with aggresive leukaemia five weeks after the birth of his son. He has raised more than 18k for the NNUH while undergoing chem at the hospital. Picture: James Barham

James Barham

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On April 2 his first child, Charlie, was born at the Norfolk and Norwich University Hospital (NNUH).

Four weeks later, on Monday May 4, the builder from Drayton got out of bed and blacked out.

The 31-year old went to A&E that day for blood tests and the next day went back to the NNUH for a bone marrow biopsy.

Just 10 minutes after leaving the hospital, he had a call. Mr Barham had an aggressive blood cancer called acute myeloid leukaemia.

We were devastated, Mr Barham said. I was in absolute bits and just couldnt believe it.

Just four days before Charlie was born, Mr Barham said he started feeling nauseous but put it down to nerves ahead of the his sons birth.

It was a long birth and a bit traumatic, he said.

He then started feeling tired but thought it was the stress of having a new baby.

Last Wednesday, the day after he was diagnosed with leukaemia, he was back at the NNUH to start weeks of chemotherapy.

No visitors are allowed because of coronavirus, but staff on Mulbarton ward have moved him to a window bed so he can see his wife Katie and Charlie through the window.

But the new dad has not let the devastating news, or visiting restrictions, get him down.

He launched a charity head shave appeal on Facebook last week to raise funds for the hospitals cancer department and encouraged friends and family to join in.

I thought it would be an opportunity to give back, Mr Barham said.

Im going to be losing my hair anyway and everyone else is in lockdown and not had a haircut for weeks so I thought their friends and family could sponsor them for a head shave too.

Mr Barham lost his locks on Wednesday and has been joined by around 50 other head shavers.

In just over a week he has smashed his target of 6,000.

More than 18,000 has now been donated to the NNUHs charity from 800 people across the world through the Just Giving website. They have had donations from the US, Italy as well as his wifes native Australia.

I wouldve been over the moon if we had raised 2,000, he said. I have got messages from people in the US and India just giving their support.

All donations will go to the NNUHs cancer department, with staff deciding how best they can use it, he said.

The ex-Taverham High School pupil said doctors had told him the cancer was unlikely to be killed by chemotherapy, meaning he will need a stem cell transplant at Addenbrookes Hospital in Cambridge.

Im fit and healthy but this cancer comes up so rapidly and can kill someone. That is what has been the most surprising thing for me, he said.

On his Just Giving fundraising page, he wrote: I have a long journey ahead of me with leukaemia as my new temporary normal.

The constant care and attention Im receiving while Im in hospital is truly exceptional, all from men and women who are overworked and seriously underpaid.

Im now in their hands, so its the least I can do to try and help them back in a small way. Your support will be greatly appreciated. Lets all go forward and be kind to one another.

Louise Cook, head of fundraising at the NNUH, said: We are incredibly grateful for the support and fundraising James, his family and friends are undertaking at this difficult time.

We are overwhelmed at the support shown to the hospital charity, where the money raised will go to support our work with cancer patients. We wish to say thank you to everyone who has got behind James fundraising.

You can donate to Jamess headshave at http://www.justgiving.com/fundraising/james-barham3

A leukaemia which comes with little warning

The NHS says symptoms of acute myeloid leukaemia (AML) can come on suddenly.

They include feeling tired and weak, weight loss and breathlessness.

This blood cancer is caused by a DNA mutation in the stem cells in the bone marrow.

The NHS website says the mutation causes the stem cells to produce many more white blood cells than are needed.

The white blood cells produced are still immature, so they do not have the infection-fighting properties of fully developed white blood cells.

As the number of immature cells increases, the amount of healthy red blood cells decreases and causes the symptoms of leukaemia.

The NHS says it is not know what triggers the genetic mutation.

Patients are treated with chemotherapy or radiotherapy but if that does not work a bone marrow or stem cell transplant may be needed.

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Brian Lindberg

Lockheed Martin Corporation has partnered with Be The Match to enable patients to continue receiving life-saving transplants without interruption during the COVID-19 pandemic by ensuring the timely delivery of bone marrow and blood stem cells for transplant, Lockheed Martin reported on Thursday.

"The incredible support from Lockheed Martin is a lifeline to our patients. For those awaiting bone marrow transplant, their very survival depends on the on-time delivery of these life-saving cells. By offering flight services, Lockheed Martin is helping us ensure that patients can continue the cells they need, exactly when they need them," said NMDP/Be The Match Chief Policy Officer Brian Lindberg.

With Lockheed Martins donation of the companys corporate aircraft, the National Marrow Donor Program (NMDP)/Be The Match was able to support the federal government's COVID-19 response and relief efforts and ensure patients that life-saving products from European donors would arrive on time.

Under the partnership, Lockheed Martin will provide weekly air transport based on government medical need. The company will fly government medical teams to the most critical, high-priority locations around the country. In addition, Lockheed Martin will transport materials to support bone marrow transport to help with the government's COVID-19 response.

In addition to matching donors and patients, one of the program's primary missions is coordinating the delivery of bone marrow domestically and internationally to patients in the United States and abroad.

Marillyn Hewson, CEO, chairman and president of Lockheed Martin and 2020 Wash100 Award recipient, recently released the companys efforts to remediate the effects of the global pandemic. In April 2020, Hewson noted that Lockheed Martin has projected that it will be able to flow down over $450 million in accelerated payments to its supply chain partners.

The funding will support those who are critical to supporting the economy and national security. Lockheed will continue its work with the Department of Health and Human Services and provide air transport of government medical teams to the most critical, high-priority locations around the country. The company also pledged $10 million in charitable contributions for COVID-19 relief and recovery efforts.

The company has donated $2 million to Project HOPE to help deliver personal protective equipment to the Federal Emergency Management Agency for distribution to America's doctors, nurses, and first responders. Lockheed also donated $2 million to the American Red Cross to support military personnel, veterans, and families and $2 million to the CDC Foundation All of Us to combat Coronavirus emergency response fund.

As we continue to face this unprecedented crisis, Lockheed Martin is driven by our commitment to the mission of our U.S. and allied customers. We will continue to maintain our operations for our men and women in uniform and we are resolved to find additional ways to contribute to the relief and recovery from COVID-19, Hewson noted.

About Lockheed Martin

Headquartered in Bethesda, Maryland, Lockheed Martin is a global security and aerospace company that employs approximately 110,000 people worldwide and is principally engaged in the research, design, development, manufacture, integration and sustainment of advanced technology systems, products and services.

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Lockheed Martin Partners with Be The Match to Expedite Delivery of Transplants During COVID-19 Pandemic; Brian Lindberg Quoted - ExecutiveGov

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MIKE TYSON has been doing the rounds to physically prepare for his sensational boxing comeback aged 53.

Tyson, who retired in 2005, has a whole new diet and cardio regime as well as going through a "weird" stem cell treatment.

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It comes after the former heavyweight king announced plans to make a return to the ring to compete in exhibition bouts for charity, and has been training for the last month to do so.

Speaking to rapper LL Cool J on the Rock the Bells Radio show on SiriusXM, Tyson explained the methods he is using to get back into fighting shape, as he revealed: "Really I would just change my diet and just do cardio work.

"Cardio has to start, you have to have your endurance to go and do the process of training.

"So something to do is get in cardio, I would try and get two hours of cardio a day, make sure you get that stuff in. Youre gonna make sure youre eating the right food.

"For me its almost like slave food. Doing what you hate to do but doing it like its nothing. Getting up when you dont want to get up.

"Thats what it is. Its becoming a slave to life.

"Being a slave to life means being the best person you can be, being the best you can possibly be, and when you are at the best you can possibly be is when you no longer exist and nobody talks about you. Thats when youre at your best."

Tyson's return to training for the first time in 15 years has been aided by stem-cell research therapy, that has left him feeling like a "different person".

Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition that usually takes the form of a bone marrow transplantation.

Tyson was asked whether that meant if his white blood had been spun and then put back in, to which he replied: "Yes. As they took the blood it was red and when it came back it was almost transfluid (sic).

"I could almost see through the blood, and then they injected it in me.

"And Ive been weird ever since, Ive got to get balanced now."

Having previously claimed he feels in the best shape of his life, Tyson revealed he will be ready to fight again in just six weeks.

He said: "My mind would belong to somebody that disliked me enough to break my soul, and I would give them my mind for that period of time.

"Six weeks of this and Id be in the best shape Ive ever dreamed of being in. As a matter of fact, Im going through that process right now. And you know what else I did, I did stem-cell research."

WHAT IS STEM CELL TREATMENT USED FOR?

Stem cell transplants are carried out when bone marrow is damaged or isnt able to produce healthy blood cells.

It can also be used to replace damaged blood cells as the result of intensive cancer treatment.

Here are conditions that stem cell transplants can be used to treat:

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MONEY MIKEMike Tyson's earnings from all his major fights revealed as he raked in 557m

BLOOD SPORTMike Tyson injected by docs with translucent blood that made him feel 'weird'

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KNOCKOUT BLONDEMeet Mila Kuznetsova, the plus-size model-turned-boxer with 34M boobs

During his reign as champion, Tyson would wake up at 4.30am to run before later heading to the gym where he would do 10-12 rounds of boxing mixed in with an array of muscles exercises.

His diet consisted of 3000-4000 calories of carbohydrates and proteins which helped fuel his training sessions.

Tyson, still the youngest heavyweight champion of all time at 20, retired with a record of 50-6-2 and remains one of the most celebrated punchers of all time.

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The targeted drug Qinlock, which interferes with the activity of proteins that drive gastrointestinal stromal tumor, has been approved by the Food and Drug Administration for patients with advanced disease that has progressed despite treatment with other kinase inhibitors.

The targeted drug, a kinase inhibitor that interferes with the activity of the cancer-driving proteins KIT and PDGFR, is for adults with GIST who have received prior treatment with three or more kinase inhibitors, including Gleevec (imatinib).

The approval is based on findings from the phase 3 INVICTUS trial, in which the drug led to an 85% reduction in the risk of disease progression or death compared with placebo for the target population.

"Despite the progress that has been made over the past 20 years in developing treatments for GIST, including four FDA-approved targeted therapies imatinib in 2002, sunitinib in 2006, regorafenib in 2013 and avapritinib earlier this year some patients don't respond to treatment and their tumors continues to progress. Today's approval provides a new treatment option for patients who have exhausted all FDA-approved therapies for GIST," Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research, stated in a press release.

Results showed that the median time until disease progression was 6.3 months with Qinlock compared with 1 month for placebo. At six months, 51% of those on the novel targeted therapy had experienced no disease progression, compared with 3.2% of those taking placebo.

Additionally, there was a 64% reduction in the risk of death with Qinlock compared with placebo. The median overall survival (the length of life from the start of study treatment) was 15.1 versus 6.6 months for Qinlock and placebo, respectively, although that findings statistical significance was not conclusively established. The six-month overall survival rate with Qinlock was 84.3% compared with 55.9% for placebo. The 12-month overall survival rate was 65.4% for Qinlock compared with 25.9% for placebo.

Finally, the objective response rate (the proportion of patients who had a complete or partial response to treatment) with Qinlock was 9.4% compared with no responses in the placebo group. These findings were not statistically significant. The median duration of response had not yet been reached, with seven of eight patients continuing to respond at the time of the data cutoff of May 31, 2019.

Side effects were experienced by 98.8% of patients in the Qinlock arm compared with 97.7% with placebo. Serious or severe side effects that emerged during treatment were experienced by 49.4% of patients in the Qinlock group compared with 44.2% of those taking placebo.

The most common side effects in the Qinlock and placebo groups, respectively, were hair loss (51.8% versus 4.7%), fatigue (42.4% versus 23.3%), nausea (38.8% versus 11.6%), abdominal pain (36.5% versus 30.2%), constipation (34.1% versus 18.6%) and muscle pain (31.8% versis 11.6%). The most common serious or severe grade side effects in the Qinlock versus placebo groups were, respectively, anemia (9.4% versus 14%), high blood pressure (7.1% versus 0%) and abdominal pain (7.1% versus 4.7%).

Check back later for what you need to know about this approval.

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FDA Approves Qinlock for Patients with Pretreated, Advanced GIST - Curetoday.com

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The coronavirus pandemic has caused significant changes and delays to treatment plans for many people battling cancer, who are more susceptible to the virus due to weakened immune systems, nationwide statistics show.

A survey conducted by The American Cancer Society Cancer Action Network in late March and early April found that half of more than 1,000 patients and survivors surveyed had seen their treatment interrupted in some way. Many are working with health care providers to alter their treatment plans skipping treatments, delaying therapies and surgeries, changing dosages and switching to virtual visits to lower their risk of exposure to the virus.

Thesurvey asked respondents about their experience accessing health care as a result of the pandemic, including the availability of appointments and services, and concerns about being able to safely get their treatments in the future. It found that27% of patients in active treatment said they have had their treatment delayed. Of those, 13% saidthey haveno clear timeline for whentreatment will resume.

Additionally, many cancer patients also have had their support systems ripped away, as they practice social isolation and see annual support events such as Relay for Life in southeastern Connecticut canceled.

Balancing risks

Approximately 20,300 people in Connecticut will be diagnosed with cancer in 2020 and 6,390 will die from the disease, according to Bryte Johnson, Connecticut Government Relations Director for American Cancer.

Andy Salner, medical director for the Hartford HealthCare Cancer Institute at Hartford Hospital, said cancer patients often have weakened immune systems, so may more easily contract the virus than someone without cancer. They alsomay developa more severe case ofthe COVID-19, the disease caused by the virus,and have a harder time fighting it.

Some cancers themselves, like multiple melanomas and most types of Leukemia, impact the immune system directly by altering blood cells. People with cancer might also be poorly nourished because cancer itself can make it hard to digest food, cancer cells can use up nutrients and cancer treatments like radiation therapy and chemotherapy can cause nausea and lack of appetite, according to the Cancer Action Network.

Radiation therapy, immunotherapy and chemotherapy also can lead to short-term immune system damage, and bone marrow or stem cell transplants that use high-dose treatments to kill cancer also may harm immune system cells for weeks to months, according to the American Cancer Society. Chemotherapy is the most common cause of a weakened immune system, because it causes a decrease in white blood cells, meaning a person's body won't be able to fight off infections as effectively.

At the Hartford Healthcare Cancer Institute in Waterford, oncologists Michael Kane and Sapna Khubchandani complete thousands of patient visits each year, and are helping patients design new treatment plansto battle and monitor their cancer while reducing their risk of exposure to the coronavirus.

For one local woman, a COVID-19 diagnosis meant missing her final session of chemotherapy, Khubchandani said. She did not identify the patient for privacy reasons.

Khubchandani said she didnt think missing one session so late in the treatment plan would have too much of an impact on the patient, but it wasnt ideal. An elective surgery related to the woman's cancer treatment, meant to take place after she completed chemotherapy, was delayed due to the virus, Khubchandani said.

COVID-19 has caused doctors to delay many suchnonemergency surgeries related to cancer treatment, including breast biopsies, lumpectomies or colonoscopies. Khubchandani, Kane and Salner all said they have had to make changes to surgery plans, either for patient safety or due to a lack of beds in intensive care units that are overwhelmed with patients battling the virus.

Doctors have been exploring alternatives, such as putting patients on hormonal treatment as they await surgery, so that were still treating the cancer while we wait, which will buy them time, Khubchandani said.

From some of his patients, Kane has made adjustments to medication dosages or administration intervals, to limit visits. Its all about individualizing treatment for each patients scenario, he said.

Worrying about the unknown

For one of Kane's patients, Richard van Etten ofHadlyme, protecting the 89-year-old from COVID-19 meant forgoing the transfusion he normally receives every three weeks.

Van Etten has been battling cancer since 2018, first in his bladder, then a cancerous module in his left lung, then in his lymph nodes.

Hecompleted chemotherapy and recently started a new drug called Keytruda, administered via infusions through a port for the cancer in his bladder and lymph nodes.

He recently learned that the cancer in his lymph nodes is gone, but his care team decided to continue his transfusions in case there were any residual cancer cells left, he said. But whenthe coronavirusbecame a concern, they decided to stop.

The virus hit and I was very hesitant about continuing my infusions, which were taking place in Waterford, he said. I talked with Dr. Kane and we decided to forgo them for now.

Since the start of the pandemic, he has been to the treatment center only once, to have his port cleaned. He said he is being very careful and is barely leaving his home, where he lives with his wife and daughter.

Van Etten said that he is absolutely anxious about contracting COVID-19, mostly due to his age. He said he feels confident about his decision to delay his treatment to limit his exposure to the virus but is worried about what might be happening inside his body.

Knowing that I was either in remission or close to it when I stopped, that it was at least temporarily under control, makes me feel OK with missing my infusions, he said. But that doesnt mean that in the back of my mind I dont wonder if it might be coming back.

Heis anxiously awaiting his next in-person visit, a PET scan scheduled for June 1, thats going to tell me whether any of the cancer has come back or not, he said.

Margie Elkins is a breast cancer survivor and active volunteer for the American Cancer Society and several other cancer organizations in southeastern Connecticut. While she is missing regular checkups and experiencing some delays in her own follow-up care, she said, One of the things that really worries me is not only the people who are experiencing delays in treatment but the people who have yet to be diagnosed, because the longer you wait in some cases, the larger the cancer becomes."

For thosewhose treatment hasbeen delayed, Its like their life is on hold because they dont know if their cancer is getting worse or getting better, she said.

Salner said delaying treatments certainly poses a risk. I think the worry would be that the cancer cells could potentially grow during that time (that treatments are delayed), that the treatment might be less effective if its delayed too far, he said.

Among survey respondents whose care had been canceled, delayed or changed by the pandemic, the most commonly impacted services were imaging procedures to monitor growth of cancer, supportive services such as therapy and in-person provider visits.

Salner said that decisions to delay chemotherapies and radiation, or reversing the order of treatments to prevent weakening of the immune system during the pandemic, were being made regularly and in partnership with patients and their families.

We want to balance making sure that we deliver the best cancer therapy possible but also place the patient at the lowest risk for getting what could be a life-threatening infection, he said.

In Waterford, Kane and Khubchandani have started screening patients for COVID-19 before starting them on chemotherapy or immunotherapy to ensure they are strong and healthy enough for the treatment. If a patient does have the virus, the doctors are delaying chemotherapy or immunotherapy in almost all cases. The ultimate decision though, is primarily left up to the patient. If they want to receive treatment, they likely will be able to, doctors agree.

Kane and Khubchandani also are implementing general precautions for people entering their offices: taking patients temperature, calling patients the day before to screen for COVID-19 symptoms and opting for virtual visits when possible. At the Waterford treatment center, theyve reduced the number of chairs in the waiting room and are scheduling laboratory services further apart. All doctors and patients are wearing masks at all times.

The extra precautions seem to be helping, Salner said. The Hartford Healthcare group has not seen a large influx of cancer patients testing positive for COVID-19.

Finding support

Some survivors are concerned about the emotional impact of COVID-19 on people currently battling cancer, worrying that they may feel overwhelmed and alone, both in their diagnosis and by social distancing.

Elkins said that she felt isolated when she was first diagnosed with stage1 breast cancer years ago, and can only imagine how that feeling is being compounded by the isolation of quarantine.

Greg Schlough, event chairman for the American Cancer Society Relay for Life of Southeastern CT, said that in his experience, cancer is a disease that causes people to really rally around you. The survivor saidthose with cancer tend to rely on their family and friends for support, like he did after being diagnosed with stage 3 melanoma on his 40th birthday in September 2000.

At the beginning, you get that doom and gloom feeling but when people start to come around and you start to see other people who have survived, you are able to say Hey, Im going to beat this thing. You know that you have people backing up and cheering you on, he said.

Right now, folks fighting cancer, especially a new diagnosis, may be struggling to find that support as they practice social distancing from their family and friends.

Schlough, in remission for 20 years, said that if he was a cancer patient right now, he would be afraid to go outside, and cant imagine how new patients are feeling.

For patients who are struggling with feelings of isolation or fear, events like the annual relay provide an opportunity to connect with others who are fighting the same fight, or who are examples of strength and survival. This years relay, which was set to be held on July 14 in Norwich, has been postponed indefinitely.

The annual fundraiser normally raises an average of $80,000 to $120,000 a year for the American Cancer Society, helping the society fund resources and support services to help people with cancer.

Schlough said organizers are hoping to reschedule the event for the end of summer, but it wouldfunction in accordance with social distancing guidelines and everyone will be required to wear masks. People currently in treatment, he said, may have to miss out or participate virtually.

Wed rather see them there next year smiling than this year with the risk of getting sick, he said.

Schloughsuggests patients or survivors who are emotionally strugglingor needhelp understanding treatment options shouldreach out to friends and family for over-the-phone support or call the American Cancer Societys hotline, 1 (800) 227-2345.

t.hartz@theday.com

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Higher risk of infection, changes to treatment makes COVID-19 a double threat for cancer patients - theday.com

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Technology across the world is improving and innovatingwith time. Over the years, man-managed labor has almost finished from themarket and more and more technological and scientific gadgets are taking placemaking human labor more effective, efficient, and precise.

Medical science has also taken a lot of advantage fromthis scientific advancement therefore, we can say that doctors are making fulluse of science and technology and the world of medicine has evolved quiterapidly.

Orthopedic hospitalshave also seena remarkable transformation over time and the days when a regular orthopedicclinic only comprised of a few tools and a bad. The launch of innovativetechnologies, biologics, and hybrid items into the orthopedic industry isincreasingly growing.

Any of these emerging inventions gain regulatory approvalby showing significant equivalence to the US System of the Food and DrugAdministration (FDA) 510(k).

Surgeons play a key role in the implementation ofemerging technology to patients and will play a leading role in supportinghealthy, efficient, adequate, and cost-effective treatment, particularly forsurgical procedures. Surgeons will track and record the health results andadverse effects of their patients utilizing modern technologies and ensure thatthe new technology works as expected.

Ortho-biologics utilizes the regenerative ability ofcells in the human body. Ortho-biologics are created from compounds naturallypresent in the body which are used to facilitate the recovery of fracturedbones which injured joints, ligaments, and tendons.

These involve bone graft, growth factors, stem cells,platelet-infused plasma, autologous blood, and autologous controlled serum. Themesenchymal stem cells (MSCs) contained in the bone marrow has been shown to besuccessful in the production of the appropriate tissues.

Result in Orthopedic Procedures

Recent advances in this area, including growth factor andstem cell therapies, may contribute to faster recovery. One breakthrough isdrug-free bone grafts, which may be used to cure conditions such as orthopedicsurgery. Clinical trials have demonstrated that growth factors can improve thehealing cycle.

Stem cells will continually self-regenerate and transforminto either form of cell, providing an unmatched source of regenerativemedicine technology. Definitions of musculoskeletal procedures utilizing stemcells are listed below.

Biotechnology firms began utilizing orthopedic stemcells. For starters, BioTime works on stem cell therapies for age-relateddegenerative diseases, IntelliCell BioSciences on adipose-derived stem cellsfor orthopedic conditions, and Bio-Tissues on Ortho-biological treatments forcartilage defects.

Orthopedic procedures using robots are less intrusive anddeliver reproducible accuracy, resulting in shorter hospital stays and quickerrecovery times. The Swiss clinic, La Source, recorded a decline in averagehospitalization from 10 to 6 days with the usage of surgical robots.Nevertheless, this technology is also costly to develop, so solid,evidence-based trials are required to prove that robotic technology contributesto improved outcomes.

The Da Vinci Surgical Method became the first U.S. Food andDrug Administration (FDA)-an authorized robotic surgery program in 2000. Morebusinesses are investing in this technology to enhance navigation duringservice or to receive 3-D scans that aid in the design of custom joints.

Organizations that are interested, in robotics areinclined towards the following technological masterpieces:

Several modern surgical techniques are enhancing theresults. These involve motion-preservation methods, minimally intrusive surgery,tissue-guided surgery, and cement-free joint repair.

Motion recovery strategies require partial or completedisk removal and the usage of active stability systems and interspinous spacersthat do not impair versatility.

Minimally intrusive procedures involve the use ofendoscopes, tubular retractors, and computer-aided guidance devices, allowingan incision of just 2 cm instead of 12 cm in conventional therapies. Minimallyinvasive treatments are gaining popularity in joint and hip replacement and spinalsurgery.

Smart devices provide built-in sensors to offer real-timetracking and post-operative evaluation details to surgeons for better patientsafety across the clinical process. Such implants have the ability to minimizeperiprosthetic infection, which is an increasing orthopedic issue.Sensor-enabled innovations also presented health care professionals with arange of innovative, cost-effective goods.

Companies working in this field include:

3-D orthopedic printing is gaining traction in themanufacture of personalized braces, surgical equipment, and orthotics from arange of materials. 3-D printing technology cuts operating times, saves energy,increases the long-term reliability of the implant, and enhances the healtheffects of surgical procedures. 3-D printing technologies of orthopedics areinclusive of:

Companies investing in 3-D Orthopedic Printing

Medical science has taken a huge turn with the introduction of technology. The orthopedic industry has also transformed to a huge extent making sure that the specialists and surgeons are able to treat and operate on their patients without any hassle. Almost all the orthopedic hospitals are equipped with high-end gadgets and tools to assist the doctor.

Even though the technology has evolved greatly since thefield of medicine was invented, it is important to understand that this is justa beginning and there are many more things to come in the future.

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The Latest Technological Innovations in Orthopedic Surgery 2020 Technology - IMC Grupo

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VANCOUVER, Washington, May 15, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced it is offering comprehensive cytokine profiling (including RANTES levels) through its diagnostic partner company, IncellDx, to help physicians understand the pathogenesis of Childhood Inflammatory Disease Related to COVID-19. These laboratory tests are exploratory in nature and not intended for clinical decision making.

Recent reports in parts of the U.S. and Europe suggest a rare and potentially fatal inflammatory disease linked to the novel coronavirus is afflicting a small number of children. The condition resembles a rare childhood illness called Kawasaki disease, which has similar signs and symptoms and can lead to enlargement of blood vessels that in severe forms may cause heart damage.

New York State Department of Health is investigating 110 reported cases and 3 deaths in children - predominantly school-aged - experiencing symptoms similar to Kawasaki disease and toxic shock-like syndrome, possibly due to COVID-19.

Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostic partner and an advisor to CytoDyn commented, Cytokines are proteins that modulate the inflammatory response. Kawasaki disease has been previously shown to be associated with elevated levels of RANTES, a protein we have shown to be significantly elevated in mild-moderate COVID-19 and over 100 times normal in critical COVID-19 patients.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn added, We hope our comprehensive cytokine testing will help physicians gain a better understanding of the disease process and, in turn, explore the prospect for leronlimab to potentially provide a therapeutic benefit to children suffering from inflammatory illness related to COVID-19.

About Coronavirus Disease 2019CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) and BLA Submission for the HIV Combination Therapy The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

The Company filed its BLA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients with the FDA on April 27, 2020, and submitted additional FDA requested clinical datasets on May 11, 2020. After the BLA submission is deemed completed, the FDA sets a PDUFA goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously assigned by the FDA, and the Company plans to request a priority review for the BLA. A priority review designation means the FDAs goal is to take action on the marketing application within six months of receipt (compared with 10 months under standard review).

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDyn CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn filed its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients, and submitted additional FDA requested clinical datasets on May 11, 2020. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking Statements This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Companys cash position, (ii) the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv) the Companys ability to enter into partnership or licensing arrangements with third parties, (v) the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Companys ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Companys clinical trials, (viii) the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEO RedChip Companies Office: 1.800.RED.CHIP (733.2447) Cell: 407.491.4498 dave@redchip.com

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CytoDyn to Offer No-Cost Exploratory Laboratory Testing for Childhood Inflammatory Disease Associated with COVID-19 - The Bakersfield Californian

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American Cancer Society: Bone Marrow and Peripheral Blood Stem Cell Transplants - The American Cancer Society is the nationwide community-based voluntary health organization dedicated to eliminating cancer as a major health problem by preventing cancer, saving lives, and diminishing suffering from cancer, through research, education, advocacy, and service. Learn the basics and read the transplant process at this site.

The Bone Marrow Foundation - The mission of The Bone Marrow Foundation is to improve the quality of life for bone marrow and stem cell transplant patients and their families by providing financial aid, education and emotional support.

BMT InfoNet - Blood & Marrow Transplant Information Network is a not-for-profit organization dedicated exclusively to serving the needs of persons facing a bone marrow, blood stem cell or umbilical cord blood transplant. Here you will find support services, a drug database and more.

Cancer.Net: Understanding Bone Marrow and Stem Cell Transplantation - This is the patient information Web site of the American Society of Clinical Oncology (ASCO).

Gift of Life - Gift of Life is an international public bone marrow and blood stem cell registry. Information will be found at this site for both donors and patients.

Macmillan Cancer Support: Stem Cell and Bone Marrow Transplants - This UK based organization helps with all the things that people affected by cancer want and need. The basics on transplants and their side effects can be found here.

MedlinePlus: Bone Marrow Transplantation - Developed by the National Library of Medicine, this consumer health site directs the user to selected online resources on many common diseases, conditions, and concerns.Also in Spanish.

MedlinePlus: Stem Cells - Developed by the National Library of Medicine, this consumer health site directs the user to selected online resources on many common diseases, conditions, and concerns.Also in Spanish.

National Bone Marrow Transplant Link (nbmtLINK) - The mission of the nbmtLINK is to help patients, as well as their caregivers, families and the health care community meet the many challenges of stem cell transplant by providing vital information and support services.

National Cancer Institute: Bone Marrow Transplantation and Peripheral Blood Stem Cell Transplantation -The NCI, established under the National Cancer Act of 1937, is the Federal Government's principal agency for cancer research and training. This informative fact sheet is in question and answer format.

National Cancer Institute: Dictionary of Cancer Terms, Stem Cell transplant - The NCI, established under the National Cancer Act of 1937, is the Federal Government's principal agency for cancer research and training. This link provides basic information on what a stem cell transplant is and provides several images to aid understanding of the process.

National Marrow Donor Program - This resource (Be The Match) provides a wealth of information for both patients and donors.Click here for translated materials on marrow donation.

Interactive Tutorials / Videos

Mayo Clinic - Bone Marrow Transplants - This video offers general information on bone marrow transplantation.

The New Normal - An Emmy-award winning film in eight parts. Features survivors stories and the transplant process.

November 2018

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Bone Marrow/Stem Cell Transplants | Rutgers Cancer ...

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MINNEAPOLIS, May 14, 2020 /PRNewswire/ --The challenges surrounding COVID-19 have impacted every aspect of healthcare, including ensuring the timely delivery of bone marrow and blood stem cells for transplant. Thanks to the generosity of the Lockheed Martin Corporation, however, patients are able to continue receiving life-saving transplants without interruption.

When the National Marrow Donor Program (NMDP)/Be The Match ran out of available European Union couriers to deliver life-saving cells to American patients and with tens of thousands of commercial flights canceled, Lockheed Martin stepped up to offer their corporate aircraft as an in-kind donation to support the federal government's COVID-19 response and relief efforts to ensure patients that life-saving products from European donors would arrive on time.

NMDP/Be The Match, operates the federally authorized program that matches unrelated volunteer donors with patients in the United States and abroad who have been diagnosed with leukemia and over 70 more otherwise fatal blood disorders and diseases.

In addition to matching donors and patients, one of the program's primary missions is coordinating the delivery of bone marrow domestically and internationally to patients in the United States and abroad. This life-or-death delivery has historically been accomplished by trained couriers hand carrying donated marrow in the passenger compartment of commercial aircraft from donor collection centers to the hospitals of patients all across the globe.

Patients who are scheduled to receive transplants in the coming days are already in the process of a carefully timed course of chemotherapy and radiation treatments designed to eliminate their existing immune systems in preparation for the transplantation of cells to create a healthy, new immune system. If the transportation of donor cells is interrupted, the consequences are fatal to these patients whose immune systems have been ablated.

"The incredible support from Lockheed Martin is a lifeline to our patients. For those awaiting bone marrow transplant, their very survival depends on the on-time delivery of these life-saving cells. By offering flight services, Lockheed Martin is helping us ensure that patients can continue the cells they need, exactly when they need them," said NMDP/Be The Match Chief Policy Officer Brian Lindberg.

As part of this partnership Lockheed Martin will be providing weekly air transport based on government medical need flying government medical teams to the most critical, high-priority locations around the country and/or flying to support bone marrow transport to help with the government's COVID-19 response.

NMDP/Be The Match has facilitated over 100,000 bone marrow transplants since 1987 to deliver cures for patients battling blood cancers and blood disorders. More than 50 percent of those transplants involve international donors or recipients.

About Be The MatchFor people with life-threatening blood cancerslike leukemia and lymphomaor other diseases, a cure exists. Be The Match connects patients with their donor match for a life-saving marrow or umbilical cord blood transplant. People can contribute to the cure as a member of the Be The Match Registry, financial contributor or volunteer. Be The Match provides patients and their families one-on-one support, education, and guidancebefore, during and after transplant.

Be The Match is operated by the National Marrow Donor Program (NMDP), a nonprofit organization that matches patients with donors, educates health care professionals and conducts research through its research program, CIBMTR (Center for International Blood and Marrow Transplant Research), so more lives can be saved. To learn more about the cure, visit BeTheMatch.orgor call 1 (800) MARROW-2.

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Lockheed Martin Steps Up To Help Save Lives And Support Be The Match During COVID-19 - Southernminn.com

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A rapid-acting bone marrow transplant developed by the Israeli biotech Gamida Cell was engrafted in blood cancer patients 10 days faster than standard umbilical cord blood transplants in a phase III trial.

The trial recruited 125 blood cancer patients in more than 50 clinical centers globally. One group received a standard transplant of donor umbilical cord blood cells and another group received Gamidas treatment omidubicel, which consists of umbilical cord blood cells that are expanded and cultured in the lab.

According to the trial results, omidubicel established itself in the patients and started making healthy new immune cells after around 12 days, measured by counting cells called neutrophils in the blood. This was significantly faster than the 22 days it took in patients given a regular umbilical cord blood transplant.

Blood cancer patients often receive stem cell transplants to replace bone marrow cells that are damaged by chemotherapy or radiation therapy. Donor stem cell transplants can come from adult bone marrow cells, stem cells in the blood, or umbilical cord blood stem cells.

A common problem with bone marrow transplants is compatibility, where the donors cells could fail to engraft or even attack the recipient if the cell types dont match properly. This problem is less common in umbilical cord blood transplants than other sources, but this type of transplant also provides a lower dose of stem cells, which can delay the engraftment process.

To solve this issue, Gamida Cells treatment is designed to take donor umbilical cord cells and boost their stem cell count in the lab prior to administering the treatment to patients.

These results have the potential to substantially move the field forward and represent an important step toward making stem cell transplantation more accessible and more successful for patients with lethal blood cancers, stated Mitchell Horwitz, Principal Investigator and Professor of Medicine at the Duke Cancer Institute, USA.

Shortening the time to engraftment is clinically meaningful, as it can reduce a patients time in the hospital and decrease the likelihood of infection.

The company aims to apply for FDA approval in late 2020, with a potential commercial launch in 2021. According to a conference call today, Gamida Cell had completed its phase III enrollment in December. This meant that the trial was luckily unaffected by the onset of the Covid-19 pandemic, which has delayed clinical trials for many companies worldwide.

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Gamida Cells Bone Marrow Transplant Cuts Treatment Time in Phase... - Labiotech.eu

Bone Marrow Stem Cells Comments Off on Gamida Cells Bone Marrow Transplant Cuts Treatment Time in Phase… – Labiotech.eu | May 14th, 2020

PERTH, Australia Australian stem cell company Mesoblast Ltd. completed a capital raising of AU$138 million (US$90 million) to scale up manufacturing of its allogeneic cell therapy, remestemcel-L, to treat COVID-19 acute respiratory distress syndrome (ARDS).

The Melbourne-headquartered company is currently enrolling patients in a randomized placebo-controlled phase II/III trial in up to 300 patients across 30 sites in the U.S. The trial is evaluating whether remestemcel-L can reduce the high mortality in COVID-19 patients with moderate to severe ARDS.

Patients are being dosed, and were really pleased how fast enrollment is growing, Mesoblast CEO Silviu Itescu told BioWorld. Were right on target and hope to update the market soon.

The phase II/III trial was initiated after promising results were seen with remestemcel-L under an emergency compassionate-use protocol in COVID-19 ARDS at Mount Sinai Hospital in New York, where nine of 12 (75%) ventilator-dependent patients were able to come off ventilators within 10 days.

Under the compassionate-use protocol, patients in intensive care units received standard-of-care treatment. Once they were intubated on a ventilator, they were treated within 72 hours with two infusions of Mesoblasts remestemcel-L cells within five days.

Once youre ventilated when you have acute respiratory distress syndrome in the lungs, your likelihood of coming off a ventilator is 9%, and your survival is 12%, Itescu said.

Whats exciting is that our patients in the same epicenter of this disease with the same treatment everyone else is getting, suddenly 75% are coming off of ventilators within 10 days, and weve got 83% survival, Itescu said.

The compassionate-use treatment experience informed the design of the phase II/III trial, and the FDA approved the same protocol, but it is powered so that results will be self-evident, Itescu said.

The phase II/III trial will randomize up to 300 ventilator-dependent patients in intensive care units to either remestemcel-L or placebo on top of standard of care, in line with guidance provided by the FDA. The primary endpoint is all-cause mortality within 30 days of randomization, with the key secondary endpoint being the number of days alive and off mechanical support.

What people are dying of is acute respiratory distress syndrome, which is the bodys immune response to the virus in the lungs, and the immune system goes haywire, and in its battle with the virus it overreacts and causes severe damage to the lungs, he said.

Capital raise allows scale up for COVID-19 and influenza

The capital raise consisted of a placement of 43 million shares to existing and new institutional investors at a price of AU$3.20 per share, representing a 7% discount to the five-day volume-weighted average price (VWAP) at the close of trading May 8. The placement was conducted with Bell Potter Securities as lead manager and underwriter. Settlement is expected to occur on Friday, May 15.

Most of the funds raised will be used to scale up manufacturing of remestemcel-L for the treatment of critically ill patients suffering with diseases causing ARDS, including COVID-19 and influenza.

Were in the middle of a pandemic, and people are talking about opening up, and theyre talking about a potential second wave, Itescu said. Its too early to talk about projections, but we need to at least be in a position to make more product in an additional facility, so that requires technology transfer and certain process improvements.

Remestemcel-L is Mesoblasts lead product, and it is currently being studied in multiple indications so the move to ramp up manufacturing is a good strategic move regardless of COVID-19, he said.

There are at least 125,000 patients every year in the United States with influenza-related acute respiratory distress syndrome in intensive care units, and those patients have got about a 40% fatality rate. Up to about 60,000 patients die per year due to influenza ARDS, so even if COVID-19 magically disappears, which we could only hope, influenza is here to stay despite vaccines being available, the CEO said.

This product would work in the same way for influenza-related ARDS as it would for COVID-19-related ARDS, he said.

The ability to build out manufacturing capacity is part of an FDA requirement to be able to demonstrate it can make product for patients in the U.S.

The company already has a manufacturing facility in Singapore, and the additional site in the U.S. would give the company the ability to provide product globally.

Were putting our strategic plan into play. You need to have multiple geographies, especially in this kind of environment, Itescu said.

Without the cash, we wouldnt have been able to deliver on this, but we now can execute.

Mesoblast's allogeneic candidates are based on mesenchymal lineage cells collected from the bone marrow of healthy adult donors.

Remestemcel-L is currently being reviewed by the FDA for potential approval in the treatment of children with steroid-refractory acute graft-vs.-host disease (aGVHD). The company submitted the final module of a rolling BLA in January. The FDA has set a PDUFA date of Sept. 30 for the product branded as Ryoncil.

The clinical data submitted with the BLA showed a survival rate of 79% compared to an expected 30% survival rate in the pediatric phase III trial in aGVHD.

Remestemcel-L is also being developed for other rare diseases. Mesoblast is completing phase III trials in advanced heart failure and chronic low back pain.

Mesoblast shares (ASX:MSB) were down 1.45% on the news, trading at AU$3.39 per share by market close May 13. On Nasdaq (MESO), shares closed at $12.15.

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Australia's Mesoblast raises $90M to scale up stem cell therapy manufacturing to treat COVID-19 ARDS - BioWorld Online

Bone Marrow Stem Cells Comments Off on Australia’s Mesoblast raises $90M to scale up stem cell therapy manufacturing to treat COVID-19 ARDS – BioWorld Online | May 14th, 2020

Scientists have made embryosthat are a lot mouse and a little bit human.

With a little help, human stem cells can knit themselves into growingmouse embryos, populating thedeveloping liver, heart, retina and blood, researchers report May 13 in Science Advances.

Finicky human cells dont tend to grow well in other animals. But in one of the new mouse embryos, 4 percent of its cells were human the most thorough mixing between human and mouse yet.

That level of integration isquite striking to me, says Juan Carlos Izpisua Belmonte, a stem cell anddevelopmental biologist at the Salk Institute for Biological Studies in LaJolla, Calif. If other scientists can replicate the findings, it potentiallyrepresents a major advance, says Izpisua Belmonte, who was not involved in thestudy.

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Such chimeras could helpreveal how a single cell can give rise to an entire organism. More humanizedanimals could also prove valuable in studying diseases such as malaria that affectpeople more than other animals. And with more advances, chimeras couldultimately turn out to be a source of human organs.

Many scientists have hitroadblocks in growing human stem cells in mice or other animals, including pigs and cows(SN: 1/26/17). We have analyzedthousands of embryos but never saw robust chimeric contribution of human stemcells to mouse embryos beyond day 12, says stem cell and developmentalbiologist Jun Wu of the University of Texas Southwestern Medical Center inDallas, who wasnt involved in the study.

The new methods success comes down to timing, says neuroscientist and stem cell biologist Jian Feng. To grow and thrive in a mouse embryo, human stem cells developmental clocks must be turned back to an earlier phase called the nave stage. You need to basically push the human cells back to that phase, says Feng, of the University at Buffalo in New York.

Feng and his colleagues resetthe stem cells clocks by silencing a protein called mTOR for three hours. Thisbrief treatment shocked the cells back to their nave stage, presumably restoringtheir ability to turn into any cell in the body.

Researchers injected batchesof 10 to 12 of these more youthful human stem cells into mouse embryos containingabout 60 to 80 mouse cells, and allowed the embryos to develop for 17 days.

To outward appearances, these embryos grew normally despite harboring human cells. By tallying DNA that was specific to either mouse or human, the researchers found that human cells accounted for between 0.1 and 4 percent of the total cells in the embryos.

Human cells knittedthemselves into most developing tissues of the mouse, destined to become theliver, heart, bone marrow and blood. Human red blood cells were particularlyabundant in these mouse embryos, the researchers found. A small number of humancells showed up in tissue that will form a brain; one embryo had a swarm of humanphotoreceptors, eye cells that help detect light.

As far as the researcherscould tell, no human cells were among the cells that go on to form sperm andegg. The capacity of chimeras to reproduce is one of the worrisome ethicalquestions surrounding the organisms that scientists are still trying to figureout.

Once inside a mouse embryo, the normally sluggish developmental pace of the human cells sped up to match their hosts. Human stem cells typically are slow to turn into certain types of mature photoreceptors, liver cells or red blood cells, Feng says, but not when the human cells are inside a mouse embryo. You put the same human cells in a mouse embryo, [and] they go fast, Feng says. In 17 days, you get all these mature cells that would otherwise take months to get in a normal human embryo.

Other scientists emphasize that different laboratories need to repeat the results. But if it works a big if here this has big implications, Wu says.

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New hybrid embryos are the most thorough mixing of humans and mice yet - Science News

Bone Marrow Stem Cells Comments Off on New hybrid embryos are the most thorough mixing of humans and mice yet – Science News | May 14th, 2020