Global Bone Marrow Aspirate Concentrates Market was valued US$ XX Bn in 2018 and is expected to reach US$ XX Bn by 2026, at CAGR of 6.5 % during forecast period of 2019 to 2026

Bone marrow concentrate (BMC) uses stem cells that are harvested from your own bone marrow to help the body heal itself. These cells when injected directly into an injury site, prompt a rapid and efficient restoration of the tissue, returning it to a more healthy state by stimulating the bodys natural healing response. It is non-surgical treatment for various orthopedic injuries, including mild to moderate osteoarthritis, disc degeneration and soft tissue injuries.

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Global Bone Marrow Aspirate Concentrates Market Drivers and RestrainsBone marrow-derived stem cell treatment is considered a promising and advanced therapy. It reduces the injury healing time in orthopedic diseases to five to six weeks from four to six months in case of surgery. Reduction in the healing time is a factor likely to fuel the Bone Marrow Aspirate Concentrates market during the forecast period.

Pain associated with the treatment, lack of awareness, and use of alternative treatments are major restraints to the Global Bone Marrow Aspirate Concentrates Market. Furthermore, increased investments in R&D and clinical trials attributed to slow approval processes entailing sunken costs, and marginal returns on investment for manufacturers are factors hindering Global Bone Marrow Aspirate Concentrates Market.

Global Bone Marrow Aspirate Concentrates Market key segmentationBy end-use market is divided into hospitals & clinics, pharmaceutical & biotechnology companies, Contract Research Organizations (CROs) & Contract Manufacturing Organizations (CMOs), and academic & research institutes. The hospitals & clinics segment dominated the bone marrow aspirate concentrates market in 2018 and is expected to maintain its dominance during the forecast period. The hospitals & clinics segmental growth is boosted by the biotechnology & biopharmaceutical companies in terms of revenue during the forecast period. Growth of the segment is attributed to increasing number of biotechnology companies and rising partnerships among the market players to expand globally.

Global Bone Marrow Aspirate Concentrates Market regional analysisBy regional analysis, global bone marrow aspirate concentrates market is divided into major five geographical regions, including North America, Europe, Asia-Pacific, Latin America and Middle East and Africa. North America held largest share of the Global Bone Marrow Aspirate Concentrates market owing to technological advancements and regulatory approval for new devices, rising awareness about stem cell therapy, and number of cosmetic surgical procedures. Furthermore, Asia Pacific orthopedic market is key driver, which led to this massive and augmented growth. The orthopedic market in Asia including bone graft, spine, and bone substitute is anticipated to grow as fast as the overall orthopedic market which will further boost growth of BMAC market in the region during forecast period.

The objective of the report is to present comprehensive analysis of Global Bone Marrow Aspirate Concentrates Market including all the stakeholders of the industry. The past and current status of the industry with forecasted market size and trends are presented in the report with the analysis of complicated data in simple language. The report covers all the aspects of industry with dedicated study of key players that includes market leaders, followers and new entrants by region. PORTER, SVOR, PESTEL analysis with the potential impact of micro-economic factors by region on the market have been presented in the report. External as well as internal factors that are supposed to affect the business positively or negatively have been analyzed, which will give clear futuristic view of the industry to the decision makers.

The report also helps in understanding Global Bone Marrow Aspirate Concentrates Market dynamics, structure by analyzing the market segments, and project the Global Bone Marrow Aspirate Concentrates Market size. Clear representation of competitive analysis of key players by Bone Marrow Aspirate Concentrates Type, price, financial position, product portfolio, growth strategies, and regional presence in the Global Bone Marrow Aspirate Concentrates Market make the report investors guide.

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Global Bone Marrow Aspirate Concentrates Market by product type

Bone Marrow Aspirate Concentrates Systems Bone Marrow Aspirate Concentrates AccessoriesGlobal Bone Marrow Aspirate Concentrates Market Application

Orthopaedic Surgery, Wound Healing, Chronic Pain, Peripheral Vascular Disease, Dermatology;Global Bone Marrow Aspirate Concentrates Market by region

Asia Pacific North America Europe Latin America Middle East AfricaGlobal Bone Marrow Aspirate Concentrates Market by end-user

Hospitals & Clinics Pharmaceutical & Biotechnology Companies Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) Academic & Research InstitutesKey players operating on Global Bone Marrow Aspirate Concentrates Market

Terumo Corporation (Terumo BCT), Ranfac Corp., Arthrex, Inc., Globus Medical, Inc., Cesca Therapeutics Inc., MK Alliance Inc. (TotipotentSC), and Zimmer Biomet Holdings, Inc Cesca Therapeutics Inc. Stryker Paul Medical Systems LIFELINX SURGIMED PVT. LTD.

MAJOR TOC OF THE REPORT

Chapter One: Bone Marrow Aspirate Concentrates (BMAC) Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Bone Marrow Aspirate Concentrates (BMAC) Market Competition, by Players

Chapter Four: Global Bone Marrow Aspirate Concentrates (BMAC) Market Size by Regions

Chapter Five: North America Bone Marrow Aspirate Concentrates (BMAC) Revenue by Countries

Chapter Six: Europe Bone Marrow Aspirate Concentrates (BMAC) Revenue by Countries

Chapter Seven: Asia-Pacific Bone Marrow Aspirate Concentrates (BMAC) Revenue by Countries

Chapter Eight: South America Bone Marrow Aspirate Concentrates (BMAC) Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Bone Marrow Aspirate Concentrates (BMAC) by Countries

Chapter Ten: Global Bone Marrow Aspirate Concentrates (BMAC) Market Segment by Type

Chapter Eleven: Global Bone Marrow Aspirate Concentrates (BMAC) Market Segment by Application

Chapter Twelve: Global Bone Marrow Aspirate Concentrates (BMAC) Market Size Forecast (2019-2026)

Browse Full Report with Facts and Figures of Bone Marrow Aspirate Concentrates (BMAC) Market Report at: https://www.maximizemarketresearch.com/market-report/global-bone-marrow-aspirate-concentrates-bmac-market/37078/

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Global Bone Marrow Aspirate Concentrates (BMAC) Market: Industry Analysis and forecast (2019 to 2026): By product Type, Application, End Users, and...

Bone Marrow Stem Cells Comments Off on Global Bone Marrow Aspirate Concentrates (BMAC) Market: Industry Analysis and forecast (2019 to 2026): By product Type, Application, End Users, and… | April 2nd, 2020

Researchers at the Institute of Oral Biology of the University of Zurich have released 2 studies that examine how stem cells promote neuronal growth in tissue regeneration and in cancer progression.

Their findings demonstrate that different stem cell populations are innervated in distinct ways and that innervation may be crucial for proper tissue regeneration, according to the study. They also demonstrate that cancer steam cells likewise establish contacts with nerves.

Stem cells can generate a variety of specific tissues that are increasingly being used for clinical application, such as the replacement of bone or cartilage, but are present in cancerous tissues and are involved in cancer progression and metastasis. Nerves are therefore fundamental for regulating the physiological and regenerative processes involving stem cells.

Using organ-on-a-chip technology, which relies on small 3-dimensional devices mimicking the basic function of human organs and tissues, the researchers demonstrated that both types of stem cells promoted neuronal growth. The dental pulp stem cells, however, yielded better results compared with bone marrow stem cells. They induced more elongated neurons, formed dense neuronal networks, and established close contacts with nerves.

Dental stem cells produce specific molecules that are fundamental for the growth and attraction of neurons. Therefore, stem cells are abundantly innervated, according to the study authors. The formation of such extended networks and the establishment of numerous contacts suggest that dental stem cells create functional connections with nerves of the face. Therefore, these cells could represent an attractive choice for the regeneration of functional, properly innervated facial tissue.

In the second study, the researchers examined the interaction between nerves and cancer stem cells found in ameloblastoma, an aggressive tumor of the mouth. They first demonstrated that ameloblastomas have stem cell properties and are innervated by facial neurons. When ameloblastoma cells were isolated and placed in the organ-on-a-chip devices, they retained not only their stem cell properties, but also attracted nerves and established contact with them.

Nerves appear to be fundamental for the survival and function of cancer stem cells. These results create new possibilities for cancer treatment using drugs that modify the communication between neurons and cancer stem cells. The researchers hope this opens unforeseen paths toward effective therapies against cancer.

The combination of advanced molecular and imaging tools and organ-on-a-chip technology offers an opportunity to reveal the hidden functions of neurons and their interactions with various stem cell types, in both healthy and pathological conditions.

Reference

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Stem Cells, Nerves Found to Interact in Cancer Progression - Pharmacy Times

Bone Marrow Stem Cells Comments Off on Stem Cells, Nerves Found to Interact in Cancer Progression – Pharmacy Times | April 1st, 2020

Dr. Jim Surrell, Journal columnist

The overall function of our human immune system is to prevent or limit infection. The primary job of our immune system is to distinguish between our normal, healthy cells and possible other dangerous cells, such as viruses and bacteria that may come into our blood stream. Our immune system is always on duty to look for and recognize these possible infectious viruses and bacteria.

The immune system looks closely at these potentially infectious cells to do all it can to prevent us from getting an infection.

Know that we rely on our immune system every day to help us fight off infections and keep us healthy. Our immune system contains numerous cell types that either circulate throughout the body or reside in our particular body tissues. Each cell type plays a unique role, with different ways of performing their function to fight off infections. Further, our great medical and scientific researchers continuously work to optimize our immune responses to confront specific potential infectious issues, such as is being done at this time with regard to the coronavirus (COVID-19).

Let us now take a look at the many components of our human immune system and how our body works to fight off infections. All of our numerous immune cells come from basic immune cells in our bone marrow and develop into mature cells through a series of changes that can occur in different parts of the body. Following is a brief look at our various body components that make up our immune system.

Skin: Our skin is usually the first line of defense against infectious organisms. Skin cells produce and secrete important antimicrobial proteins, and immune cells can be found in specific layers of our skin.

Bone marrow: Our bone marrow contains stem cells that can develop into a variety of cell types. These stem cells in our bone marrow develop our many various types of immune cells that are very important first-line responders to infection. These stem cells create our essential infection-fighting cells, called B cells and T cells. These B cells and T cells are responsible for mounting a response to specific microbes that may cause infections. We also have natural niller (NK) immune cells that also provide defenses to fight off infections. These immune system B cells, T cells, and NK cells are also called lymphocytes.

Bloodstream: Immune cells constantly circulate throughout the bloodstream, patrolling for problems. When blood tests are used to monitor white blood cells, another term for immune cells, a snapshot of the immune system is taken. If our white blood cells are too few, or overabundant in the bloodstream, this may reflect a problem that should be addressed by a professional health care provider.

Thymus Gland: Immune system T cells mature in our small thymus gland, located in the upper chest.

Lymphatic system: The lymphatic system is a network of vessels and tissues composed of lymph, an extracellular fluid, and our lymph nodes. The lymphatic system is the essential part of our immune system that provides communication between our various body tissues and our bloodstream. Immune cells are carried through the lymphatic system and converge in lymph nodes. Lymph nodes are a communication hub where immune cells sample information brought in from the body. Thus, doctors may check patients for swollen lymph nodes, which may indicate an active immune response.

Spleen: The spleen is an organ located behind the stomach. Immune cells are found in the spleen and if there are any blood-borne infectious organisms, these immune cells activate and respond accordingly.

Lastly, be aware that our human immune system regenerates and repairs itself every night when we sleep. Studies show that people who dont get quality sleep or enough sleep are more likely to get sick after being exposed to an infectious virus or bacteria. Lack of sleep can also affect how fast you recover if you do get sick. To keep you and your immune system healthy, get the recommended seven to eight hours of sleep each and every night. And yes, these are Doctors Orders!

EDITORS NOTE: Dr. Jim Surrell is the author of The ABCs For Success In All We Do and the SOS (Stop Only Sugar) Diet books. Requests for health topics for this column are encouraged. Contact Dr. Surrell by email at sosdietdoc@gmail.com.

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Talk with the Doc | News, Sports, Jobs - Marquette Mining Journal

Bone Marrow Stem Cells Comments Off on Talk with the Doc | News, Sports, Jobs – Marquette Mining Journal | April 1st, 2020

VIVA! Communications

Australians living with an incurable blood cancer set to receive new reimbursed treatment option

Australians living with the incurable blood cancer, multiple myeloma1 are set to gain access to a new treatment option, with the listing of REVLIMID(lenalidomide) for maintenance treatment on the Pharmaceutical Benefits Scheme (PBS) from Wednesday April 1, 2020.2

REVLIMID(lenalidomide) represents Australias first and only maintenance treatment specifically indicated and reimbursed for those newly diagnosed with multiple myeloma (NDMM) who have undergone an autologous stem cell transplant (ASCT). 2, 3

This announcement coincides with an article just published in Medical Journal of Australias MJA Insight, calling for timely access to effective treatments for those living with multiple myeloma.4

According to article author, Professor Miles Prince, Clinical Haematologist and Director of Cancer Immunology and Molecular Oncology (Epworth Healthcare, Melbourne), continuing to broaden access to multiple myeloma treatments is critical to improving patient quality of life.4

Currently, people living with myeloma have a median survival rate of more than seven years which is significant in comparison to the median survival rate of just three years in the early 2000s.4

For survival rates to continue to improve however, patients must receive timely access to the most effective treatments, said Prof. Prince.

The PBS listing of maintenance for multiple myeloma will provide newly diagnosed patients with an additional treatment option for their disease.

Not to be confused with the skin cancer, melanoma, multiple myeloma is an incurable blood cancer that develops from plasma cells, a type of white blood cell found in the bone marrow.5, 6

Representing Australias third most common blood cancer (after lymphoma and leukaemia),7, 8 approximately 18,000 Australians are living with multiple myeloma at any given time,1 only half of whom will survive five years post- diagnosis.9

Myeloma Australia CEO, Steve Roach, today welcomed the availability of a new treatment option for the incurable disease.

The multiple myeloma patient journey involves a pattern of Response, Remission and Relapse, with individuals responding differently to certain treatments due to the complex nature of the devastating disease.

Additional treatment options are required throughout the patient journey, for both the newly diagnosed, and those who have already commenced therapy. Although incurable, we hope that multiple myeloma will one day be treated as a chronic, rather than a terminal disease, Mr Roach said.

The incurable nature of the disease and the likelihood of relapse, may have a psychological impact on patients, who can continue to live in fear even during periods of remission.10, 11

With studies revealing more than half (52%) of those living with multiple myeloma experience symptoms of anxiety or depression,12 improving access to treatment, and extending time spent in remission, may help to improve psychological wellbeing.

Wife and mother-to-two, Maria (53) was diagnosed with multiple myeloma in December 2018 and found her initial diagnosis very overwhelming.

When my husband Danny and I first heard the diagnosis, we were completely overwhelmed. We didnt know what Myeloma was and we didnt know what this meant short or long term. I didnt know if I was going to die in a month, a year or 10 years. How on earth was I going to tell everyone I had cancer, said Maria.

During my journey I blogged about my experience with multiple myeloma and posted to my Facebook daily to keep the calls and fears of my family and friends at bay. I have since accepted that myeloma is now a part of my life. I have no anger or fear and instead just live in the moment and take one day at a time.

Its very exciting to see new treatment options for multiple myeloma being funded by the government, and I hope to keep raising awareness, to ensure the myeloma community continues to receive access to the best treatment options available, Maria said.

About multiple myeloma

Multiple myeloma is a cancer that develops from abnormal plasma cells. A plasma cell is a type of white blood cell found in the bone marrow, that forms part of the immune system and helps to protect against infection.4, 7 The abnormal plasma cells crowd the bone marrow and make it difficult to produce enough normal blood cells.7

Multiple myeloma can be challenging to diagnose due to its wide range of symptoms, including high blood calcium levels, anaemia, fatigue, kidney failure, recurrent infections and bone pain.6

Current treatment for multiple myeloma includes a continuous approach, often comprising initial therapy, consolidation maintenance, and salvage therapy.13 Treatment options for multiple myeloma include chemotherapy, corticosteroids, autologous stem cell transplant (ASCT), immunomodulating drugs (IMiDs) monoclonal antibodies therapy, and proteasome inhibitors.14, 15

About REVLIMID (lenalidomide)

Representing an oral medication approved for the treatment of relapsed myeloma over 10 years ago,16 REVLIMID is an immunomodulating agent (IMiD) that slows the growth of multiple myeloma plasma tumour cells and proteins know to play a key role multiple myeloma, delays the development of new blood vessels, and enhances immune function.3

The most commonly reported side-effects of REVLIMID include diarrhoea, constipation, nausea, vomiting, stomach pain, indigestion, dehydration, dry mouth, mouth ulcer, sore mouth, increase or decrease in weight, increase or decrease in appetite, loss of taste, itchiness, rash, redness of the skin, dry skin, bruising, excessive sweating, dizziness, fainting, headache, shaking or tremors, unusual weakness, night sweats, reduced sense of touch, difficulty sleeping, depression, anxiety, feeling of confusion, back pain, muscle spasms, muscle and/or joint pain, swollen joints, bone pain, muscular weakness, pain in the extremities, feeling tired, falling, swelling of hands, ankles or feet.17

Other possible side effects of REVLIMID include heart palpitations or fast heartbeat, chest pains, dizziness or fainting, shortness of breath, weakness or reduced ability to exercise, bleeding (including nose-bleeds), bruising more than usual, numbness, tingling, blurred vision or difficulty seeing, passing large amounts of urine, excessive thirst, and having a dry mouth and skin, abnormal eye movements, convulsions, mood changes, irregular heart rhythms or tender swollen lymph nodes. 17

All patients receiving REVLIMID must be registered on, and abide by the requirements of, i-access risk management program to avoid exposure to unborn babies, due to the potential for birth defects. It is important to note that a small number of patients with multiple myeloma may develop additional types of cancer, regardless of their type of therapy. At this stage, it cannot be excluded that this risk may be slightly increased with REVLIMID maintenance treatment.17

Disclosure

Celgene supports disclosure and transparency on interactions between the healthcare industry and healthcare professionals to ensure public trust and confidence. No expert spokespeople have been offered compensation for their involvement in this media campaign. All expert spokespeople have been briefed on the approved use of these products and their obligations with regard to promotion to the general public. Prof Miles Prince and Myeloma Australia have received funding from Celgene for projects unrelated to this announcement. All opinions expressed are their own.

About Celgene

Celgene, a Bristol-Myers Squibb Company, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialisation of innovative therapies for the treatment of cancer and inflammatory diseases, through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation.

/Public Release.

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Australians living with an incurable blood cancer set to receive new reimbursed treatment option - Mirage News

Bone Marrow Stem Cells Comments Off on Australians living with an incurable blood cancer set to receive new reimbursed treatment option – Mirage News | April 1st, 2020

VANCOUVER, Washington, March 30, 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, announced today that an additional three critically ill COVID-19 patients have been treated with leronlimab. These additional patients increase the total to 10 patients receiving leronlimab treatment under an Emergency Investigational New Drug (EIND) granted by the U.S. Food and Drug Administration (FDA).

The treatment with leronlimab is targeted as a therapy for patients who experience respiratory complications as a result of contracting SARS-CoV-2 causing the Coronavirus Disease 2019 (COVID-19). Leronlimab is believed to provide therapeutic benefit by enhancing the immune response while mitigating the cytokine storm that leads to morbidity and mortality in these patients. The laboratory evaluation of the first four patients treated with leronlimab revealed that the immune profile in these patients approached normal levels and the levels of cytokines involved in the cytokine storm (including IL-6 and TNF alpha) were much improved. The results of the three additional patients are expected this week.

Jacob Lalezari, M.D., Interim Chief Medical Officer of CytoDyn, commented, The preliminary results observed in patients who were severely ill with COVID-19 and treated with leronlimab are encouraging. Although the data set is still small, we saw fairly rapid and positive laboratory responses in all 4 patients treated, and in three of the 4 patients these laboratory results were associated with a favorable clinical outcome. We eagerly await the results of additional patients treated under the FDAs emergency IND program, as well as the results of several randomized clinical trials about to start.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, added, We remain encouraged and hopeful that leronlimab will help patients from this devastating and relentless disease. We will aggressively pursue treatment for COVID-19 patients, and to explore leronlimabs role in helping to alleviate the impending burden of supply chain and institutional capacity issues.

About Coronavirus Disease 2019SARS-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) 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.

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 plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in April of 2020 for that indication. 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 with no reported drug-related serious adverse events (SAEs). 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. 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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Three Additional Patients with Severe COVID-19 Treated with Leronlimab in New York Medical Center Bringing the Total to 10 Patients - Associated Press

Bone Marrow Stem Cells Comments Off on Three Additional Patients with Severe COVID-19 Treated with Leronlimab in New York Medical Center Bringing the Total to 10 Patients – Associated Press | March 31st, 2020

Dailymail.co.uk

Adam Castillejo (pictured), 40, was known only as the London Patient when doctors revealed his success story last March after a stem cell transplant to treat his cancer.

The second person to be cured of HIV has revealed how he was more fearful of dying from cancer than Aids and considered ending his life at Dignitas.Adam Castillejo, 40, was known only as the London Patient when doctors revealed his success story last March after a stem cell transplant to treat his cancer.He remained anonymous until he decided he wanted to be seen as an ambassador of hope after struggling with his health for almost two decades.Mr Castillejo, who was born in Venezuela and moved to London in 2002, was diagnosed with blood cancer in 2012, having already lived with HIV since 2003.His last hope of cancer survival was a bone marrow transplant from a donor with HIV-resistant genes that could wipe out his cancer and virus in one fell swoop.But in a powerful interview with The Sunday Times,Mr Castillejo admitted that he was more fearful of dying from stage 4 Hodgkins lymphoma than Aids.Calling the second diagnosis another death sentence, the sou-chef revealed that he panicked because cancer can kill you faster than HIV.Adam Castillejo, 40, was known only as the London Patient when doctors revealed his success story last March after a stem cell transplant to treat his cancerMr Castillejo embarked upon a gruelling treatment regime that left him physically emaciated and pushed the Venezuelan to the mental edge.Both illnesses became one because you had to deal with the anti-retroviral medications not interfering with thechemotherapy regime and vice versa, he said.By the end of 2014, he said that he had given up on battling the two illnesses, and had made up his mind to end it all at Dignitas in Switzerland.Around this time,Mr Castillejo disappeared, and was found four days later outside London psychologically broken. He does not remember this period.Doctors gave him six months to live, before a switch flicked.At that time I accepted straight away, because what choice have I got? I would rather die fighting, he explained.Within days, he met with Dr Ian Gabriel at the Chelsea and Westminster Hospital, who advised that he could attempt a bone marrow transplant.The procedure in May 2016 meantMr Castillejo was cleared of both cancer and HIV.But he lost five stone and took 60 pills a day, revealing: I told my doctors there werent enough hours in the day to take all the medication I needed.Mr Castillejo, who was born in Venezuela and moved to London in 2002, was diagnosed with blood cancer in 2012, having already lived with HIV since 2003An American man treated in Germany 12 years ago called Timothy Ray Brown (pictured) the so-called Berlin Patient also survived the transplantHe also developed mouth ulcers which inhibited his ability to eat, and his anti-retroviral medication had to be crushed and washed down.Mr Castillejo also claimed that he felt victimised and guilty when he told people that he was suffering from HIV, saying: This is a punishment for you.The Venezuelan chef is the second person to have survived the life-threatening technique and come out the other side HIV-free.An American man treated in Germany 12 years ago called Timothy Ray Brown the so-called Berlin Patient also survived the transplant.He was put into an induced coma for six months, however.Experts have hailed the treatment as a milestone in the fight against HIV, but are urging caution when calling it a cure so early on.In the context of HIV infection, the term cure means there are no virus-carrying cells left.Anti-retroviral therapy is very effective at reducing the viral load in the blood of infected individuals so that it cannot be transmitted to others.Unfortunately, the Berlin and London Patients cases do not change the reality much for 37 million HIV patients.The treatment is unlikely to have potential on a wider scale because both Mr Castillejo and Mr Ray Brown were given stem cells to treat cancer, not HIV.Stem cell and bone marrow transplants are life-threatening operations with huge risks. Patients can suffer a fatal reaction if substitute immune cells dont take.In his private life, Mr Castillejo likes to walk the streets of Shoreditch and travel.Kat Smithson, director of policy at National AIDS Trust, said: We applaud the London Patient Adam Castillejo for sharing his unique experience of having his HIV cured following a bone-marrow transplant to treat cancer. Mr Castillejo has been through a long and extremely challenging journey with his health, within which HIV is just one part.His decision to speak about his experience without anonymity can only enrich our understanding of his experience on a human level, and we thank him for this.Theres still a great deal of stigma around HIV which can make it harder for people to access the services and support they need and for people to talk openly about HIV.His story helps raise much-needed awareness of HIV, but broader than that its a story about incredible resilience, determination and hope.How a stem cell transplant cured the Berlin and London Patients and how it can go badly wrongUsually, HIV patients expect to stay on daily pills for life to suppress the virus. When drugs are stopped, the virus roars back, usually in two to three weeksThe vast majority of humans carry the gene CCR5.In many ways, it is incredibly unhelpful. It affects our odds of surviving and recovering from a stroke, according to recent research.And it is the main access point for HIV to overtake our immune systems.But some people carry a mutations that prevents CCR5 from expressing itself, effectively blocking or eliminating the gene.Those few people in the world are called elite controllers by HIV experts. They are naturally resistant to HIV.If the virus ever entered their body, they would naturally control the virus as if they were taking the virus-suppressing drugs that HIV patients require.Both the Berlin patient and the London patient received stem cells donated from people with that crucial mutation.WHY HAS IT NEVER WORKED BEFORE?There are many reasons this hasnt worked, Dr Janet Siliciano, at the Johns Hopkins University School of Medicine, told DailyMail.com.1. FINDING DONORSIts incredibly difficult to find HLA-matched bone marrow [i.e. someone with the same proteins in their blood as you], Dr Siliciano said.Its even more difficult to find the CCR5 mutation.2. INEFFECTIVE TRANSPLANT LEADS TO CANCER RELAPSESecond, there is a risk that the bone marrow wont take.Sometimes you dont become fully chimeric, meaning you still have a lot of your own cells.This means they will not defeat the cancer if it returns again.3. THE OLD IMMUNE SYSTEM ATTACKS THE NEW ONEThe other most common reason this approach has failed is graft-versus-host disease: whenthe patients immune system tries to attack the incoming, replacement immune system, causing a fatal reaction in most.4. UNKNOWN QUANTITIESInterestingly, both the Berlin patient and the London patient experienced complications that are normally lethal in most other cases.And experts believe that those complications helped their cases.Timothy Ray Brown, the Berlin patient, had both his cancer returned and he developed graft-versus-host disease, putting him in a coma and requiring a second bone marrow transplant.The London patient had one: he suffered graft-versus-host disease.Against the odds, they both survived, HIV-free.Some believe that, ironically, graft-versus-host disease might have helped both of them to further obliterate their HIV.But there is no way to control or replicate that safely.

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Adam Castillejo 'feared dying of cancer more than Aids and considered ending it all at Dignitas' Daily Mail - westofthepond.com

Bone Marrow Stem Cells Comments Off on Adam Castillejo ‘feared dying of cancer more than Aids and considered ending it all at Dignitas’ Daily Mail – westofthepond.com | March 31st, 2020

Researchers at UCL have developed a new way to make blood stem cells present in the umbilical cord 'more transplantable', a finding in mice which could improve the treatment of a wide range of blood diseases in children and adults.

Blood stem cells, also known as haematopoietic stem cells (HSCs), generate every type of cell in the blood (red cells, white cells and platelets), and are responsible for maintaining blood production throughout life.

When treating certain cancers and inherited blood disorders, it is sometimes necessary to replace the bone marrow by allogeneic stem cell transplantation - which involves using stem cells from a healthy donor.

The umbilical cord is a useful source of blood stem cells, and cord blood transplants lead to fewer long-term immune complications than bone marrow transplants. Although umbilical cord transplants have been used in young children for the last 30 years, most cord blood units* contain insufficient HSCs to be suitable for older children and adults and 30% of all units contain too few even for the youngest children, and go to waste.

The study, published in the journal Cell Stem Cell, highlights how a protein called NOV/CCN3, which is normally found at low levels in the blood, can be used to rapidly increase the number HSCs in single umbilical cord blood units that are capable of transplantation. This finding potentially opens the door to units that would otherwise be discarded being made available for patients of all ages.

"Trying to increase the actual number of hematopoietic stem cells in umbilical cord blood is both expensive and challenging. It is known that not all HSCs present in a cord blood unit can or will transplant, indicating that cord blood units have untapped transplantation potential," explained Dr Rajeev Gupta, Clinical Associate Professor at UCL Cancer Institute and first author of the study.

"We explored an alternative approach to harness this potential by increasing the functionality - rather than the number - of HSCs, and so enhance the ability of umbilical cord blood units to transplant.

"We'd previously discovered that a regulatory protein known as NOV is essential for the normal function of human HSCs, and so we asked whether highly purified NOV might be used to manipulate cord blood HSCs to make them more transplantable."

Using cell cultures and mouse models in the lab, the research team at UCL Cancer Institute found that umbilical cord blood units exposed to NOV showed significantly more transplantation potential than regular samples. In fact, the frequency of functional HSCs in the sample increased six-fold. Strikingly, these effects were achieved with only an eight-hour exposure.

"Using NOV, we've shown that we can rapidly manipulate blood stem cells to alter their state - changing non-functioning HSCs to functioning HSCs - which enhances cord blood engraftment potential. This finding offers a new strategy for improving blood transplants. The next stage will be to take our research into a clinical setting to explore how this can benefit patients with blood cancers and other blood disorders," said Dr Gupta.

Commenting on the study, Professor Alejandro Madrigal, Scientific Director of the Anthony Nolan Institute, and a world-leading scientist in the field of stem cell transplantation, said: "Cord blood transplantation has been shown to improve engraftment and provide a better outcome for many people. However, unfortunately, stem cells numbers in many cord blood units might be inadequate for optimal transplantation.

"This research is extremely encouraging, since with the simple addition of NOV/CCN3, there is an increase in the functionality of existing stem cells.

"This practical solution could enable many more cord blood units, which have a limited number of stem cells, to be made available for transplantation and could make a huge difference to the many patients."

Reference:Gupta, R., Turati, V., Brian, D., Thrussel, C., Wilbourn, B., May, G., & Enver, T. (2020). Nov/CCN3 Enhances Cord Blood Engraftment by Rapidly Recruiting Latent Human Stem Cell Activity. Cell Stem Cell. https://doi.org/10.1016/j.stem.2020.02.012

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

*A 'cord blood unit' is one sample of blood retrieved from one umbilical cord.

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More Effective Stem Cell Transplant Method Could Aid Blood Cancer Patients - Technology Networks

Bone Marrow Stem Cells Comments Off on More Effective Stem Cell Transplant Method Could Aid Blood Cancer Patients – Technology Networks | March 28th, 2020

LONDON--(BUSINESS WIRE)--The global hematopoietic stem cells transplantation (HSCT) market is poised to grow by USD 4.64 billion during 2020-2024, progressing at a CAGR of about 6% during the forecast period. Request free sample pages

Read the 120-page report with TOC on "Hematopoietic Stem Cells Transplantation (HSCT) Market Analysis Report by Type (Autologous HSCT and Allogeneic HSCT), Geographic segmentation (Asia, Europe, North America, and ROW), and the Segment Forecasts, 2020-2024".

https://www.technavio.com/report/hematopoietic-stem-cells-transplantation-market-industry-analysis

The market is driven by the availability of technologically advanced equipment. In addition, the growing demand for personalized medicine is anticipated to boost the growth of the hematopoietic stem cells transplantation (HSCT) market.

The increasing efforts on improving the success rates of HSCT procedure is encouraging the adoption of advanced technologies and sophisticated instruments. For instance, Marrow Cellution, a patented technology, was developed by Ranfac. This technology is gaining traction in the market as it addresses the issues associated with conventional transplant syringe. It prevents contamination of peripheral blood during transplantation. In addition, this technology allows high-quality stem and progenitor cells to harvest within a narrow space. Thus, the availability of technologically advanced equipment is expected to drive market growth during the forecast period.

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Major Five Hematopoietic Stem Cells Transplantation (HSCT) Market Companies:

AllCells Corp.

AllCells Corp. provides mobilized leukopak, bone marrow and cord blood, whole blood, and leukopak. They also offer Cord Blood, which are collected from a single umbilical cord. They are cryopreserved and offered in the format of isolated cells. Cord Blood products include progenitor cells and CD34 HSCs.

bluebird bio Inc.

bluebird bio Inc. focuses on research, development, and commercialization of potentially transformative gene therapies. The company provides Zynteglo, which is a medicine used to treat patients of 12 years and older who are affected by a blood disorder known as beta thalassaemia.

FUJIFILM Holdings Corp.

FUJIFILM Holdings Corp. operates under various business segments, namely Imaging solutions, Healthcare and material solutions, and Document solutions. The company offers iCell Hematopoietic Progenitor Cells 2.0.

Lineage Cell Therapeutics Inc.

Lineage Cell Therapeutics Inc. focuses on research and development of therapeutic products for blood plasma volume expansion, orthopedics, oncology, diagnostic products for the early detection of cancer, neurological diseases and disorders, and more. The company provides OpRegen, which is in Phase I/IIa clinical trial.

Lonza Group Ltd.

Lonza Group Ltd. offers products through the following business segments: Pharma Biotech and Nutrition and Specialty ingredients. The company offers a wide range of stem cells such as bone marrow stromal cells, human peripheral blood CD14+ monocytes, cryopreseverd human CD34+ cells isolated from single donor, osteoclast precusor, and more.

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Hematopoietic Stem Cells Transplantation (HSCT) Market Type Outlook (Revenue, USD Billion, 2020-2024)

Hematopoietic Stem Cells Transplantation (HSCT) Market Geographic Outlook (Revenue, USD Billion, 2020-2024)

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Related Reports on Health Care Include:

Allogeneic Stem Cells Market Global Allogeneic Stem Cells Market by geography (Asia, Europe, North America, and ROW) and application (regenerative therapy and drug discovery and development).

Cancer Stem Cell Therapeutics Market Global Cancer Stem Cell Therapeutics Market by type (allogeneic stem cell transplant and autologous stem cell transplant) and geography (Asia, Europe, North America, and ROW).

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Global Hematopoietic Stem Cells Transplantation (HSCT) Market 2020-2024 | Evolving Opportunities with AllCells Corp. and bluebird bio Inc. | Technavio...

Bone Marrow Stem Cells Comments Off on Global Hematopoietic Stem Cells Transplantation (HSCT) Market 2020-2024 | Evolving Opportunities with AllCells Corp. and bluebird bio Inc. | Technavio… | March 28th, 2020

Mar. 27 /CSRwire/ - As an international non-profit organization, every day DKMS provides 20 lifesaving blood stem cell transplants for blood cancer and blood disorder patients all around the world. Even in the current situation that we are facing with COVID-19, these patients still urgently need our help. It is for this reason that we keep fighting and continue to work together and collaborate with the international blood stem cell community to be able to overcome all barriers, to give as many patients as possible, who are in urgent need of a life-saving blood stem cell transplant, with a second chance at life.

IMPORTANCE OF REGISTRATION

Due to the advice and directions from the health authorities regarding the COVID-19 virus and to play our part to flatten the curve, we have postponed all of our planned donor drives/registration events in all of our six countries. We want to make sure that we look after and protect all of our donors and volunteers. For the thousands of patients around the world who are not able to find a perfect match, we still urgently need to add more donors to the database. We are thankful for every registration and you can still order your registration kit online atwww.dkms.org. Registering is simple and straightforward and you can become a potential lifesaver!

PROTECTING OUR DONORS

Patients around the world still urgently need blood stem cell transplants to survive. This is why we ask all of our donors to make themselves available if they are a match for a patient. The health and well-being of our donors is our number one priority and we consider every case on an individual basis. We will always do everything possible to ensure the safety of our donors.

We have implemented screening for the COVID-19 virus risks before entry to collection centers and before the start of a donation.

These measures serve to protect the donor as well as the recipient and the employees in the collection centers. Health experts have confirmed that there is currently no evidence that the COVID-19 virus can be transmitted via blood, bone marrow, or stem cell products.

We are grateful for every one of our incredible donors and for their commitment to providing patients with a second chance at life.

TRANSPORT OF BLOOD STEM CELL PRODUCTS

75% of all of our life-saving blood stem cell collections from DKMS donors travel across borders to patients in other countries. Due to the travel restrictions imposed by many countries because of the COVID-19 virus, we are faced with additional challenges in ensuring patients receive their transplant.

When it comes to transplants, time is crucial and we are determined to find solutions to be able to provide patients in need with their transplant. We are joining forces with other members of the international transplant community and national and international authorities in order to overcome these challenges. Despite the added difficulties that we are facing at the moment, as always, we are determined to overcome all barriers in order to provide as many patients as possible with a second chance at life.

FAQ's

1. WHY HAVE DONOR DRIVES BEEN CANCELLED OR POSTPONED AND WHAT IS THE ALTERNATIVE?

In light of the increasing spread of the COVID-19 virus, DKMS is postponing all planned events and registration drives for new potential blood stem cell donors until further notice. DKMS sees itself with a special duty of care and with these measures specifically follows the recommendations of the Centers for Disease Control to protect of the population.

Blood cancer patients around the world are still in urgent need of bone marrow and blood stem cell transplants and many are still not able to find a matching donor. This is why DKMS continues to encourage everyone that is able to, to register as a blood stem cell donor and if required, to also make themselves available for a donation."We must not abandon any patient who is currently searching for a blood stem cell donor or waiting for a life-saving blood stem cell transplant. In this difficult situation, I urgently ask that everyone continues to make themselves available as donors. We are taking all precautions necessary to protect each and every one of our donors in the best possible way," said Dr. Elke Neujahr, Global CEO DKMS.

We are grateful for every registration and to enable everyone that is interested to be able to register, DKMS offers the possibility of virtual donor drives that gives initiators, families and friends the opportunity to host a virtual drive to add more potential lifesavers to the donor pool via our online platform which can be found by clicking herehttps://dkmsgetinvolved.org/virtual-donor-drive. With this capability, any planned on ground registration drives can take place digitally instead and potential donors, which are urgently needed, can still register. The links to the online registration drives can be shared via all channels.

As always, registering as a blood stem cell donor via our homepage atwww.dkms.orgis also possible. Anyone who is interested can easily order a registration kit to be sent to their home. With the help of three cotton swabs and clear instructions, as well as a consent form, every potential new donor can take a cheek swab themselves and send it via post back to DKMS. In the DKMS Life Science Lab the individual HLA characteristics (also: tissue characteristics) of the donor are then analyzed, allowing the potential donor to be registered in the DKMS database.

The difference between the online registration drives and the general online registration is that the online registration drives are linked to particular patient appeals and the number of donors can be tracked accordingly. However, in general, it doesnt matter how you register, you will always be available as a potential lifesaver for blood cancer and blood disorder patients searching for a matching donor all over the world!

2. AM I STILL ABLE TO REGISTER ONLINE IF I SUSPECT THAT I MAY HAVE OR DO HAVE COVID- 19?

If it has been confirmed that you have been infected with the COVID-19 virus or you are awaiting test results, you unfortunately will not be able to register until 3 months after the infection has passed.

3. I REGISTERED ONLINE AND HAVENT RECEIVED A CONFIRMATION, IS THERE A DELAY?

We ask anyone registering as a potential donor online for their understanding. Normally we send all registration kits that we receive to our lab within 24 hours, however we are currently waiting 7 days until we do this to ensure the protection of our staff handling the returned registration kits. Please be assured that the analysis of your sample and HLA characteristics that is required for us to add you to the register, will take place as soon as possible.

4. HOW WILL DKMS MAINTAIN THE SAFETY OF DONORS?

The health and safety of our donors is our highest priority. We will consider the circumstances of all of our donors who are asked to donate their bone marrow and blood stem cells, on an individual basis, especially regarding their travel to a collection center. Please be reassured that we provide the best and safest solution possible for our donors.

Unfortunately, donors who live in high risk areas have to be blocked for search requests, as they are currently not eligible to proceed with a donation. We also have implemented screening for the COVID-19 virus risks before entry to any collection center and before the start of a donation. These measures serve to protect the donor as well as the recipient and the employees in the collection centers. Health experts have confirmed that there is currently no evidence that the novel Coronavirus can be transmitted via blood, bone marrow, or stem cell products.

Please also understand that any planned collection may be postponed or cancelled due to the current situation. We will keep you informed about all developments. Regarding the transport of blood stem cell products to the respective transplant clinics, we are in regular and close contact with all parties involved as well as with all relevant national and international authorities and organizations, to ensure that all blood stem cell collections can reach the patients.

5. IS THERE AN INCREASED CHANCE OF DONORS CONTRACTING THE COVID-19 VIRUS DURING THE DONATION PROCEDURE OR PREPARATION FOR THE PR

There is no risk of contracting the COVID-19 virus as a result of a blood stem cell collection. The health and safety of our donors is our number one priority and we will always ensure all procedures are in place to protect their safety.

6. CAN DONORS POSTPONE THEIR DONATION AT THIS TIME?

The final decision to donate is always made by the actual donor. If you have been asked to donate and have any concerns, please contact your DKMS coordinator. We evaluate each case on an individual basis to find the best solution for all parties involved.

7. IS IT STILL SAFE FOR PATIENTS TO RECEIVE A TRANSPLANT?

Health experts have confirmed that there is currently no evidence that the novel Coronavirus can be transmitted via blood, bone marrow, or stem cell products.

8. HOW IS THE TRANSPORT OF COLLECTIONS FROM DONORS IMPACTED BY THE CURRENT TRAVEL RESTRICTIONS?

The majority of blood stem cell collections from DKMS donors travel across borders to patients in other countries. Due to the travel restrictions imposed by many countries we are in regular and close contact with all parties involved in the transport, as well as with the relevant national and international authorities and organizations. Despite the added difficulties that we are facing at the moment, we are, as always, determined to overcome all barriers in order to provide as many patients as possible with a second chance at life.

9. HOW IS DKMS RESPONDING TO THE CURRENT TRAVEL RESTRICTIONS IN THE US?

Due to the restrictions on entry into the USA, DKMS has been in contact with the World Marrow Donor Association (WMDA) and the National Marrow Donor Program (NMDP). Together, we obtained special permits for stem cell couriers from Germany and Europe to enter the USA.

10. HOW WILL THE SPREAD OF THE COVID-19 VIRUS AFFECT DKMS AND ITS OPERATIONS?

As with every organization across the world, DKMS faces challenges caused by COVID-19 and some of the potential impacts are still not yet known. The goal of DKMS remains the same as it always has been and that is, together with our outstanding team of donors and employees, to give as many patients as possible around the world a second chance at life, through a life-saving bone marrow and blood stem cell transplant. The management team of DKMS is working around the clock together with all DKMS employees and relevant stakeholders to achieve this goal.

11. HOW WILL DKMS RESPOND AS THE SITUATION EVOLVES?

A dedicated team made up of experts from relevant departments at DKMS is constantly monitoring and evaluating the ongoing situation and will act accordingly. We will continue to keep our donors and all stakeholders updated.

12. IS DKMS TESTING POTENTIAL DONORS DURING THE REGISTRATION PROCESS?

DKMS does not test potential donors who register with us for the COVID-19 virus. If you are confirmed to have the virus, we ask that you do not register with us for the next 3 months. For donors who are asked to donate we have implemented screening for the COVID-19 virus risks before entering any collection center and before the start of a donation. These measures serve to protect the donor as well as the recipient and the employees in the collection center.

13. IF I AM A POTENTIAL DONOR AND I HAVE QUESTIONS, WHO SHOULD I CONTACT?

If you have been contacted by DKMS as a potential donor and if you have any questions or concerns, you are encourage to contact your DKMS coordinator. As always, DKMS staff is there to help you through the process and answer any questions that you may have.

14. IS THERE A NEED FOR QUARANTINE OR TESTING OF STEM CELL PRODUCTS BEFORE TRANSPLANTATION?

Although SARS-CoV and MERS-CoV have been detected in blood, there have not been any reports of transmission from donor to recipient either in transfusion of blood products or cellular therapies. As there is no evidence of transmission via blood, bone marrow, or stem cell products DKMS endorses the recommendations of the regulatory agencies such as the FDA and AABB which currently do not recommend or require product testing or to quarantine the stem cell product. For more information, please visit:share.wmda.info.

If a patient is in need of a transplant, there is no need to wait or prolong the process by testing or quarantining the stem cell product. Planned transplantations can go ahead.

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Now More Than Ever, the Importance of Second Chances at Life - CSRwire.com

Bone Marrow Stem Cells Comments Off on Now More Than Ever, the Importance of Second Chances at Life – CSRwire.com | March 28th, 2020

Global Hematopoietic Stem Cell Transplantation (HSCT) Market Viewpoint

Decorated with a team of 300+ analysts, Hematopoietic Stem Cell Transplantation (HSCT) Market Report serves each and every requirement of the clients while preparing market reports. With digital intelligence solutions, we offer actionable insights to our customers that help them in overcoming market challenges. Our dedicated team of professionals perform an extensive survey for gathering accurate information associated with the market.

Hematopoietic Stem Cell Transplantation (HSCT) Market Research, in its latest business report elaborates the current situation of the global Hematopoietic Stem Cell Transplantation (HSCT) market in terms of volume (x units), value (Mn/Bn USD), production, and consumption. The report scrutinizes the market into various segments, end uses, regions and players on the basis of demand pattern, and future prospect.

In this Hematopoietic Stem Cell Transplantation (HSCT) market study, the following years are considered to project the market footprint:

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The following manufacturers are covered:Escape Therapeutics Inc.Cryo-Save AGRegen Biopharma Inc.CBR Systems Inc.ViaCord Inc.Lonza Group Ltd.Pluristem Therapeutics Inc.China Cord Blood Corp.

Segment by RegionsNorth AmericaEuropeChinaJapanSoutheast AsiaIndia

Segment by TypeAllogeneicAutologous

Segment by ApplicationPeripheral Blood Stem Cells Transplant (PBSCT)Bone Marrow Transplant (BMT)Cord Blood Transplant (CBT)

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Hematopoietic Stem Cell Transplantation (HSCT) Market Projected to Experience Major Revenue Boost During the Period Between 2019-2048 - Daily Science

Bone Marrow Stem Cells Comments Off on Hematopoietic Stem Cell Transplantation (HSCT) Market Projected to Experience Major Revenue Boost During the Period Between 2019-2048 – Daily Science | March 28th, 2020

The Global Stem Cells Market is expected to grow from USD 115.46 Million in 2018 to USD 325.84 Million by the end of 2025 at a Compound Annual Growth Rate (CAGR) of 15.97%.

The global Stem Cells market research report is a professional research report and in-depth study on the current state on the Stem Cells practices market industry.

The research report presents global drivers, restraints, opportunities trends and forecasts up to 2025. The report further indicates the positive aspects of the industry that influence market growth and trends.

Some of the prominent players operating in this market include: The report deeply explores the recent significant developments by the leading vendors and innovation profiles in the Global Stem Cells Market including are Anterogen Co., Ltd., Holostem Terapie Avanzate Srl, Medipost Co., Ltd., Osiris Therapeutics, Inc., Pharmicell Co., Ltd., Allosource, JCR Pharmaceuticals Co., Ltd., Nuvasive, Inc., and RTI Surgical, Inc.. On the basis of Cell Source, the Global Stem Cells Market is studied across Adipose Tissue-Derived Mesenchymal Stem Cells, Bone Marrow-Derived Mesenchymal Stem Cells, and Cord Blood/Embryonic Stem Cells.On the basis of Type, the Global Stem Cells Market is studied across Allogeneic Stem Cell Therapy and Autologous.On the basis of Therapeutic Application , the Global Stem Cells Market is studied across Cardiovascular Diseases, Gastrointestinal Diseases, Musculoskeletal Disorders, Surgeries, and Wounds and Injuries.

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The report overviews the industry including definitions and classifications. The Stem Cells Market report provides international markets including development trends, competitive landscape analysis and key development regions. Market strategies and development policies are briefly discussed. Furthermore, manufacturing process, cost, price and revenue are deeply analysed with a reflection to import/export consumption, supply and demand, and national & international gross-margins.

The objective of Studies:

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The Stem Cells industry is lucrative due to the presence of several small and large market players. Market strategies adopted by manufactures for increasing the sales in the market have been presented. The data and manufacturers are evaluated on the basis of basic information, manufacturing information, and competitors. The recent developments that took place in the global Stem Cells market and their impact on the future growth of the market have also been presented in the industry.

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Players Expected to Witness Maximum Growth | Stem Cells Market - Monroe Scoop

Bone Marrow Stem Cells Comments Off on Players Expected to Witness Maximum Growth | Stem Cells Market – Monroe Scoop | March 28th, 2020

In the past, an injury to the stifle joint of a horse may have certainly ended his or her career or usefulness. Now, with the ever-evolving science of veterinary medicine, afflictions to the joint have a much higher chance of being treated or even healed.

One of the reasons a stifle injury gives apprehension to horse owners is the complicated nature of the joint said Scott Cammack, D.V.M. He practices at Northern Hills Veterinary Clinic in Sturgis, South Dakota, with several other specialists.

Cammack explains that its treatment is much more involved than similar injuries. For example, an injury to the hock can often be resolved by fusing the bottom two joints (the hock consists of four total). Because it is a low-motion joint, the horse will still be sound and function after fusion.

The stifle, on the other hand, is a high-motion joint. Its got a lot of things going on in there. It doesnt have the capacity to be fused and still be sound. I would consider that they are more serious. They are more prone to long-term issues than a hock is, in my mind, he said.

According to Dr. Cammack, the stifle is anatomically similar to a human knee. All the parts are similar to your knee. Just as athletes injure their knees, they injure themselves. They have a patella, theyve got meniscuses, theyve got anterior and posterior cruciate ligaments, theyve got collateral ligaments. One major difference is that humans have one patellar ligament coming off the kneecap, while horses have three. Therefore, horses can have very unique issues.

One condition, often found in younger horses (aged 2-6) is the intermittent upward fixation of the patella or simply a catchy stifle. Dr. Cammack describes this condition: The locking mechanism of the stifle is inappropriately keeping the leg in the locked, extended position. They cant bend their leg and it only bends at the fetlock. That one is one that we treat in different ways. Sometimes, well do a procedure where we put a needle in the medial patellar ligament and we split it a little bit and cause it to thicken up and tighten up a little bit to help correct that. So thats a pretty simple procedure.

Another condition found in younger horses is OCD (osteochondrosis) lesions, a developmental issue. According to Dr. Cammack, they are cyst-like lesions on the bone. Some of them fill in and some require surgery. We saw one just the other day. A four year old had large cysts up in the bone. All they did was turn the horse out and waited. That one filled in on its own, but thats not common. Usually youre injecting the cyst or putting a screw across it or various treatments for something like that.

On the other hand, older horses may have very different afflictions in the joint. He said, In my mind, youre going to see more of the soft tissue injuries in your younger horses and more of the osteoarthritis in the older horses.

Older horses are going to be more prone to seeing arthritis in their stifle, which might be secondary to an injury it had had way back when. They injured a collateral ligament and it wasnt diagnosed, or they have some instability from ligament damage and then it healed some and they got by with it. Years down the road, youre seeing the arthritis, the osteoarthritis in there.

Stifle injuries are often seen in performance horses in various disciplines. When you start getting into any disciplines where theyre having to run hard, turn hard, stop hard, spin. We see it more in the reined cow horses and the reiners and the barrel horses, Dr. Cammack said. However, injuries can occur on the ranch or in other disciplines, as well. Certainly any horse can catch some bad ground or find a hole in the ground or something that can cause them injury.

Interestingly, younger horses may be more prone to injuries that occur in the arena. We are doing our futurities and so much heavy training on them when theyre young and they dont have the muscle memory and the skillset to have their leg in the right place at the right time with that amount of force on it.

Dr. Cammacks procedure for examining horses includes a flex test, where the joint is stressed momentarily to determine the location of any potential weaknesses in the joints. The end goal is to determine how to optimize the horses performance without masking any problems. If the horse deals with chronic issues, the typical injection of HA (hyaluronic acid), a type of steroid, may be administered, costing around $175.

For other injuries, different types of injections may do the trick. Theres certainly a lot more going on with regenerative medicine than there used to be, Dr. Cammack said. Using PRP (platelet-rich plasma) can help the joint heal itself. Youre taking the blood and processing it and pulling out platelet-rich plasma. Its going to have healing factors and certain proteins that can help the joint get better. This may cost around $250.

Theres another one called pro-stride, which is another form of PRP, but its a more concentrated form of PRP. Its more like $450. If youre getting into stem cells, that goes right up. We just pull the bone marrow or the fat, depending on which form were doing and we send it in. With that sample that we send in, we have to send $2,300 to the laboratory. That one can be in excess of $2,500 to do stem cells, Dr. Cammack said. Its an exciting area.

Cammack has devoted his professional career to the study of equines and particularly their joints and movement.

When I was in college, I started working at this clinic with Dr. Margie Jones. I developed a strong affinity for equine work and did a year internship with an equine surgeon in California, but he did a sports medicine practice and then I got in the deep pool of sports medicine and developed a deep love for it, he said.

More severe injuries to the stifle may involve surgeries, which range vastly in involvement and price.

This article serves as a brief overview of a very large field of veterinary study. Dr. Cammack devotes much of his practice and time to learning more about the equine, attending the yearly American Association of Equine Practitioners conferences, and expanding into regenerative medicine.

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Stifle injuries and treatments - Tri-State Livestock News

Bone Marrow Stem Cells Comments Off on Stifle injuries and treatments – Tri-State Livestock News | March 28th, 2020

GOLDEN, CO / ACCESSWIRE / March 26, 2020 / Vitro Diagnostics, Inc. (OTC:VODG), dba Vitro Biopharma, announced its 1st quarter ended January 31st, 2020 financial results of operations.

Vitro Diagnostics Inc. ("Vitro Biopharma") is pleased to announce a record 1st comparative quarter in Total Revenues. Vitro Biopharma recorded 1st quarter revenues of $225,921 vs $192,895 an increase of 17% over the same comparative quarter last year. In addition, Stem Cell treatments accounted for 74% of the revenues up from 71% of the revenues in the prior comparative quarter last year. Current quarter stem cell revenues were $167,750 for the 1st quarter ended January 31, 2020 vs $137,123 for the first quarter ended January 31, 2019.

The company's gross profit margins improved to 75% up from 73% in the comparative prior year's quarter. Gross margin improvement is in line with the strategic direction of the company to expand the market of its flagship product AlloRx Stem Cells. The company's clean-room lab expansion last year and expanded Stem Cell manufacturing using its patent-pending cell line, has increased efficiencies and lowered production costs.

Overall operating expenses increased in the quarter to $193,385 from $147,398 in the prior year's comparative quarter. The increase in expenses reflects additional investment as the Company expands its capability to service its strategic direction of offshore Stem Cell treatments while also expanding into US markets. The company expended additional resources on external consultants supporting our regulatory status in maintaining ISO9001 & ISO13485 certifications, expanding our efforts to approach US markets through FDA filings and advancement of existing patent filings.

The company's first quarter is its most seasonal quarter as the period between Thanksgiving and the New Year is slow for all the company's revenue lines of Nutra Vivo/STEMulize, AlloRx Stem Cells, private labeled InfiniVive-MD Stem Cell Serum and our core research products.

During the quarter the company achieved and pursed the following company objectives

During the quarter the company commenced a Series A Convertible Preferred Stock offering to accredited investors under the SEC Regulation D exemption. The preferred Stock is priced at $25 per share which is convertible at $0.25 cents per share for a total of 100 shares. The minimum investment is $50,000 per unit. The company sold $450,000 of the Series A Convertible Preferred Stock during the quarter. The company has additional interest in the offering and subsequent to the quarter has sold an additional $50,000 unit for a total to date of $500,000. The company has additional interested parties for approximately $200,000. The offering is for a total of $1,000,000.

Our partnership with DVC. Stem in the Cayman Islands continued to advance through treatment of new & previous patients. This IRB-approved protocol targets patients with inflammatory conditions including multiple sclerosis, systemic inflammation and new indications including Chrohn's disease, Alzheimer's disease and COPD. To date we have treated 60 patients including repeat treatments. There have been no serious adverse events and we continue to gain evidence of efficacy. One of the initial MS patients has now received a second transplant of our AlloRx Stem Cells and he has reported significant therapeutic benefits of both the initial and subsequent therapy. He had received an earlier transplant of adipose-derived MSCs that was effective, but the improvement lasted 3 months while AlloRx Stem Cell therapy lasted 18 months. We had predicted such a clinical outcome based on significantly higher potency of umbilical cord MSCS compared to those derived from adipose tissue or bone marrow. The Chrohn's disease patient showed significant improvement as did both the AD & COPD patients.

The strategic development of our stem cell therapies involves pursuit of both offshore and domestic markets. The partnership with DVC Stem, our IRB-approved trial in the Bahamas together with other strategic opportunities represent offshore operations & prospects. During Q1 2020, we initiated expansion into US therapeutic markets through development of an Investigational New Drug (IND) application for submission to FDA. Once approved, an IND allows the conduct of clinical trials for specific medical conditions in the US.

Given the current COVID-19 pandemic, our initial IND application is for use of AlloRx Stem Cells in treatment of Coronavirus infections. This is supported by clinical studies showing that 17 critically ill patients responded favorably to IV infusion of umbilical cord-derived MSCs. All patients were receiving assisted ventilation but 3 days following stem cell therapy, were removed from ventilators and subsequently discharged from the hospital. We are pursuing discussions with FDA to establish the appropriate regulatory pathway and expedited review options given the current emergency circumstances. (See Subsequent Events, below, for additional discussion of our COVID-19 response.) Once our initial IND is in place, we have plans for additional INDs for stem cell therapy of musculoskeletal conditions and Alzheimer's disease.

We have received an initial order of AlloRx Stem Cells for testing purposes by PR Medica located in Cabo San Lucas. Given successful test results, we anticipate subsequent new revenue generation from this customer.

Vitro Biopharma's cosmetic topical stem cell serum is being distributed by InfiniVive MD into cosmetic clinics that are providing the topical treatment as a beautification product. To date the company's product is being offered in 10 cosmetic clinics.

Our partner, Dr Jack Zamora, MD was a keynote speaker at a master session at the American Academy of Cosmetic Surgery annual meeting in late February. The topic of his presentation was "Topical Stem Cells, Exosomes and Conditioned Media Serums in Aesthetics." This was the official launch of the InfiniVive-MD platform including: Dailey Serum, Stem Cell Serum 2.0 & Exosomes within the product line. Vitro Biopharma will manufacture & private label these new products for distribution in the US. We anticipate InfiniVive MD growth, development and revenues to mirror the development of Apyx subdermal plasma skin tightening as a cosmetic treatment and technique that has gone global.

http://www.jackzamoramd.com http://www.infinivivemd.com

Our core research product sales continued to expand in Q1 2020. Our facility expansion continued with addition of manufacturing capacity and development of plans to add operational facility to increase outputs further by 100% or more. We were also in discussions with the USPTO regarding our pending patents for our novel stem cell therapy and stem cell activation technology. We continue to work closely with our examiner and have established communication channels to facilitate awards of these patents.

The COVD-19 pandemic is a significant obstacle for all business. However, Vitro Biopharma is uniquely positioned since we have a potential effective therapy. This is based on 3 independent reports showing efficacy of stem cell therapy in 17 COVID-19 patients. All were treated with IV umbilical cord MSCs comparable to AlloRx Stem Cells and all 17 required respiratory assistance but within 3-4 days of treatment, were able to breath without ventilators and were discharged within 14 days. https://www.scmp.com/news/china/society/article/3053080/coronavirus-critically-ill-chinese-patient-saved-stem-cell On the contrary, untreated patients on ventilators have death rates of 50% or more. We have received a formal request to supply AlloRx Stem Cells for compassionate use from a major university medical center and several other potential clinical partners have also expressed interest in using our cells to treat COVID-19 patients. We are presently working with the FDA to gain authority to begin clinical testing in the US. We are currently assessing the overall financial impact of the COVID-19 pandemic on our business, but this depends on overall control of the pandemic. There have been no staff layoffs and our workers are considered essential since we conduct essential research to the COVID-19 response.

Dr. Jim Musick, CEO of Vitro Biopharma, said, "We are very pleased with the increased revenue growth during our first quarter 2020 compared to the prior year However all our resources are currently focused on the emergency response to the COVID-19 pandemic and increasing our inventory of AlloRx to satisfy anticipated emergency demand to treat critically ill COVID-19 patients." The Company is working to get expedited clinical trial approvals to sell our AlloRx Stem Cells to hospitals coping with the pandemic. Vitro is pleased to have recently been recognized by Bioinformant as "a Company Tracking the Coronavirus". https://bioinformant.com/product/coronavirus-covid-19-report/ We anticipate clinical progress in the effectiveness of our stem cell therapies while expecting to see a reduction in our offshore and cosmetic revenues for the next quarter or two. The company is in a good cash position to weather this storm and simultaneously advance its AlloRx stem cell therapies into clinical trials.

In summary, Vitro Biopharma is advancing as a key player in regenerative medicine with 10- years' experience in the development and commercialization of stem cell products for research, recognized by a Best in Practice Technology Innovation Leadership award for Stem Cell Tools and Technology and a growing track record of successful translation to therapy. We are leveraging our proprietary technology platform to the establishment of international Stem Cell Centers of Excellence and regulatory approvals in the US and worldwide.

Sincerely yours,

James R. Musick, PhD.President, CEO & Chairman of the Boardwww.vitrobiopharma.com

Forward-Looking Statements

Statements herein regarding financial performance have not yet been reported to the SEC nor reviewed by the Company's auditors. Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements". Such forward looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT:

Dr. James MusickChief Executive OfficerVitro BioPharma(303) 999-2130 Ext. 3E-mail: jim@vitrobiopharma.comwww.vitrobiopharma.com

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant.

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant.

SOURCE: Vitro Diagnostics, Inc.

View source version on accesswire.com: https://www.accesswire.com/582759/Vitro-Biopharma-First-Quarter-ended-January-31-2020-Financial-Results-of-Operations

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Vitro Biopharma First Quarter ended January 31, 2020 Financial Results of Operations - Benzinga

Bone Marrow Stem Cells Comments Off on Vitro Biopharma First Quarter ended January 31, 2020 Financial Results of Operations – Benzinga | March 26th, 2020

The positioning of the Global Cell Isolation/Cell Separation Market vendors in FPNV Positioning Matrix are determined by Business Strategy (Business Growth, Industry Coverage, Financial Viability, and Channel Support) and Product Satisfaction (Value for Money, Ease of Use, Product Features, and Customer Support) and placed into four quadrants (F: Forefront, P: Pathfinders, N: Niche, and V: Vital).

New York, March 25, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Cell Isolation/Cell Separation Market - Premium Insight, Competitive News Feed Analysis, Company Usability Profiles, Market Sizing & Forecasts to 2025" - https://www.reportlinker.com/p05872137/?utm_source=GNW

The report deeply explores the recent significant developments by the leading vendors and innovation profiles in the Global Cell Isolation/Cell Separation Market including are Beckman Coulter Inc. (Subsidiary of Danaher Corporation), Becton, Dickinson and Company, Merck KGaA, Terumo Bct, Thermo Fisher Scientific, Inc., Bio-Rad Laboratories, Inc., GE Healthcare, Miltenyi Biotec, Pluriselect Life Science Ug (Haftungsbeschrnkt) & Co. Kg, and Stemcell Technologies, Inc..

On the basis of Product, the Global Cell Isolation/Cell Separation Market is studied across Consumables and Instruments.

On the basis of Cell Type, the Global Cell Isolation/Cell Separation Market is studied across Animal Cells and Human Cells.

On the basis of Cell Source, the Global Cell Isolation/Cell Separation Market is studied across Adipose Tissue, Bone Marrow, and Cord Blood/Embryonic Stem Cells.

On the basis of Technique, the Global Cell Isolation/Cell Separation Market is studied across Centrifugation-Based Cell Isolation, Filtration-Based Cell Isolation, and Surface Marker-Based Cell Isolation.

On the basis of Application, the Global Cell Isolation/Cell Separation Market is studied across Biomolecule Isolation, Cancer Research, In Vitro Diagnostics, Stem Cell Research, and Tissue Regeneration & Regenerative Medicine.

On the basis of End User, the Global Cell Isolation/Cell Separation Market is studied across Biotechnology & Biopharmaceutical Companies, Hospitals & Diagnostic Laboratories, and Research Laboratories & Institutes.

For the detailed coverage of the study, the market has been geographically divided into the Americas, Asia-Pacific, and Europe, Middle East & Africa. The report provides details of qualitative and quantitative insights about the major countries in the region and taps the major regional developments in detail.

In the report, we have covered two proprietary models, the FPNV Positioning Matrix and Competitive Strategic Window. The FPNV Positioning Matrix analyses the competitive market place for the players in terms of product satisfaction and business strategy they adopt to sustain in the market. The Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies. The Competitive Strategic Window helps the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. During a forecast period, it defines the optimal or favorable fit for the vendors to adopt successive merger and acquisitions strategies, geography expansion, research & development, new product introduction strategies to execute further business expansion and growth.

Research Methodology:Our market forecasting is based on a market model derived from market connectivity, dynamics, and identified influential factors around which assumptions about the market are made. These assumptions are enlightened by fact-bases, put by primary and secondary research instruments, regressive analysis and an extensive connect with industry people. Market forecasting derived from in-depth understanding attained from future market spending patterns provides quantified insight to support your decision-making process. The interview is recorded, and the information gathered in put on the drawing board with the information collected through secondary research.

The report provides insights on the following pointers:1. Market Penetration: Provides comprehensive information on sulfuric acid offered by the key players in the Global Cell Isolation/Cell Separation Market 2. Product Development & Innovation: Provides intelligent insights on future technologies, R&D activities, and new product developments in the Global Cell Isolation/Cell Separation Market 3. Market Development: Provides in-depth information about lucrative emerging markets and analyzes the markets for the Global Cell Isolation/Cell Separation Market 4. Market Diversification: Provides detailed information about new products launches, untapped geographies, recent developments, and investments in the Global Cell Isolation/Cell Separation Market 5. Competitive Assessment & Intelligence: Provides an exhaustive assessment of market shares, strategies, products, and manufacturing capabilities of the leading players in the Global Cell Isolation/Cell Separation Market

The report answers questions such as:1. What is the market size of Cell Isolation/Cell Separation market in the Global?2. What are the factors that affect the growth in the Global Cell Isolation/Cell Separation Market over the forecast period?3. What is the competitive position in the Global Cell Isolation/Cell Separation Market?4. Which are the best product areas to be invested in over the forecast period in the Global Cell Isolation/Cell Separation Market?5. What are the opportunities in the Global Cell Isolation/Cell Separation Market?6. What are the modes of entering the Global Cell Isolation/Cell Separation Market?Read the full report: https://www.reportlinker.com/p05872137/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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The Global Cell Isolation/Cell Separation Market is expected to grow from USD 5,721.23 Million in 2018 to USD 15,089.25 Million by the end of 2025 at...

Bone Marrow Stem Cells Comments Off on The Global Cell Isolation/Cell Separation Market is expected to grow from USD 5,721.23 Million in 2018 to USD 15,089.25 Million by the end of 2025 at… | March 25th, 2020

Veterans in Pain (VIP) is a national program for veterans who have been hurt severely in combat. Their mission is facilitating regenerative medical solutions for veterans suffering from chronic pain by connecting civilian physicians with our countrys heroes, nationwide.

Dr. Joseph Kanan and his medical staff at Tullahoma Chiropractic Center recently joined the program and performed their first pro bono procedure for a veteran named Ryan in February.

Ryan had severe right hip pain when he came in. My medical team and I gave him a $6,500 procedure, injecting stem cells into his hip, Kanan said. There is no insurance company that covers this procedure so either he would have had to pay for it himself or the VIP organization would have had to do it. We decided to do it for free.

Veteran Ryan, 36, thanks Dr. Kanan after his procedure at Tullahoma Chiropractic Center.

Stem cells are part of the bodys natural repair process. Humans have them in their bone marrow and fat cells. When they are placed at the site of damaged tissue, these stem cells can activate to become the healthy new cells the body needs for pain relief.

No-surgery stem cell therapy helps the body heal damage and relieve pain from arthritis, aging and injuries to joints, tendons, ligaments and muscles.

I think veterans do a lot for our country and there are very few doctors that are performing medical procedures like this, Kanan said. We were very glad to be able to do this for him.

Ryan, 36, lives three hours away. He drove to Tullahoma himself for the procedure. Veterans in Pain provided the funds for his hotel stay while he was in town.

The procedure was done on Feb. 13. He did feel better right after, but this is a procedure where the results take time. You experience 10 percent of improvement every month for 10 months, Kanan said. I own the clinic and I am a chiropractor, so I did not actually perform this procedure. My medical team Jana Wood and Dr. Frank Perry performed the procedure, which was giving injections into Ryans hip.

Tullahoma Chiropractic Center performs these scheduled procedures twice a month. The medical team has seen positive results from the injections, according to Kanan.

I just talked to a patient this morning that had the procedure done one year ago. He had doctors recommending a knee replacement on his left knee. My medical team conducted the stem cell procedure on his knee, Kanan said.

The experience was great. I came in and got the injection and now my knee is fluid. About three months after the injection, I felt a lot better, the patient said. It was much better than having a knee replacement. I am very passionate about golf and my knee was preventing me from doing what I loved. After a year, it is magnitudes better than it was one year ago.

Tullahoma Chiropractic Center is located at 1490 N. Jackson St.

More here:
Veterans in Pain helps ease the pain for veterans - Tullahoma News and Guardian

Bone Marrow Stem Cells Comments Off on Veterans in Pain helps ease the pain for veterans – Tullahoma News and Guardian | March 24th, 2020

LEXINGTON, Mass., March 24, 2020 /PRNewswire/ --Partner Therapeutics, Inc. (PTx) announced that Leukine (sargramostim, rhu-GM-CSF)is being assessed in the SARPAC trial (sargramostim inpatients withacute hypoxic respiratory failure due toCOVID-19 EudraCT #2020-001254-22) at University Hospital Ghent to treat patients with respiratory illness associated with COVID-19. Major medical centers in Germany, Italy and Spain are considering joining the study. The study will evaluate the effect of Leukine on lung function and patient outcomes.

"Patients with COVID-19 who progress to acute hypoxic respiratory failure due to COVID-19 have very limited treatment options and a high mortality rate," said Prof. Bart Lambrecht, Principal Investigator for the trial at University Hospital Ghent and the Flanders Institute of Biotechnology (VIB). "We rapidly initiated this study with Leukine, because GM-CSF has profound effects on antiviral immunity, can provide the stimulus to restore immune homeostasis in the lung, and can promote lung repair mechanisms."

Granulocyte macrophage colony stimulating factor (GM-CSF) is essential for the health of the lungs. Alveolar macrophages, a cell type found in the lungs, are dependent on GM-CSF for differentiation and normal functioning. GM-CSF is an immunomodulator that plays a critical role in host defense against pathogens and maintaining proper functioning of the immune system.1 GM-CSF confers resistance to influenza by enhancing innate immune mechanisms.2 In animal studies, GM-CSF reduced morbidity and mortality due to acute respiratory distress syndrome (ARDS) from viral pneumonia.3 In clinical studies, use of Leukine showed beneficial effects in patients with viral pneumonia.4,5 Recent data highlight the importance of understanding the immune status of patients and role of immunomodulating agents like GM-CSF to activate the immune system to help clear virus and reduce the risk of secondary infections.6

"Partner Therapeutics is committed to investigating Leukine in patients with COVID-19 and we are working with academic and government agencies here in the US and in Europe in this effort," said Dr. Debasish Roychowdhury, Chief Medical Officer at Partner Therapeutics. "We believe, like many investigators and scientists, that GM-CSF has multiple ways by which it may help these patients, including playing a role in clearing the infection, boosting the immune system and repairing damaged tissues."

"In pre-clinical studies, GM-CSF protects the lungs from viral pneumonia and the influenza A virus", stated E. Scott Halstead, MD, PhD, Associate Professor, Penn State University College of Medicine, Department of Pediatrics, Division of Pediatric Critical Care Medicine. "Preliminary data indicate an apparent benefit of inhaled Leukine therapy for autoimmune pulmonary alveolar proteinosis ("aPAP") and suggest it has reduced the need for whole lung lavage therapy for patients receiving treatment. Collectively, the data suggest that aerosolized Leukine may prove to be a meaningful therapy to decrease mortality and increase ventilator-free days in patients with respiratory disorders associated with viruses such as COVID-19 and Influenza A."

For the treatment of COVID-19 associated acute hypoxic respiratory failure and ARDS, Leukine will be used in nebulized form for direct inhalation or through intravenous administration for patients already on a respirator. Nebulized Leukine has been studied in phase 2 and phase 3 randomizedtrials in pulmonary conditions that affect alveolar macrophages, such as aPAP. IV administration of Leukine has been studied extensively in other conditions and in phase 2 randomized trials in ARDS.

Leukine was initially approved in the United States in 1991 and has been approved for use in five clinical indications. Its safety and tolerability profile are well understood. In 2018, Leukine was approved for use as a medical countermeasure to treat Acute Radiation Syndrome (ARS) and has been procured for use by the U.S. Strategic National Stockpile. Leukine is distributed outside the U.S. on a named-patient basis through PTx's designated program manager, Tanner Pharma Group. The use of Leukine to treat respiratory disorders associated with COVID-19 is investigational and has not been fully evaluated by any regulatory authority.

Please see full Prescribing Information for LEUKINE at http://www.leukine.com

About Leukine(sargramostim)Leukine is a yeast-derived recombinant humanized granulocyte-macrophage colony stimulating factor (rhuGM-CSF) and the only FDA approved GM-CSF. GM-CSF is an important leukocyte growth factor known to play a key role in hematopoiesis, epithelial repair, and augmentation of innate host defense by effecting the growth and maturation of multiple cell lineages as well as the functional activities of these cells in antigen presentation and cell mediated immunity.

Important Safety Information for LEUKINE (sargramostim)

Contraindications

Warnings and Precautions

Adverse Reactions

Adverse events occurring in >10% of patients receiving LEUKINE in controlled clinical trials and reported in a higher frequency than placebo are:

Please see full Prescribing Information for LEUKINE at http://www.leukine.com

Indications and Usage

LEUKINE (sargramostim) is a leukocyte growth factor indicated for the following uses:

About Partner Therapeutics, Inc.: PTx is an U.S.-based commercial-stage biotech company focused on the development and commercialization of therapeutics that improve health outcomes in the treatment of cancer. PTx's development focus spans the entire range of cancer therapy from primary treatments to supportive care. The company believes in delivering great products with the purpose of creating the best possible outcomes for patients and their families.

References

Cited References

Other RelevantReferences

SOURCE Partner Therapeutics, Inc.

http://www.partnertx.com

Original post:
Partner Therapeutics Announces Initiation of Clinical Trial to Evaluate Leukine in Patients with COVID-19 Associated Respiratory Illness - PRNewswire

Bone Marrow Stem Cells Comments Off on Partner Therapeutics Announces Initiation of Clinical Trial to Evaluate Leukine in Patients with COVID-19 Associated Respiratory Illness – PRNewswire | March 24th, 2020

VANCOUVER, Washington, March 23, 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, announced today that the third and fourth coronavirus patients were treated with the Companys investigational new drug, leronlimab. The treatment of the third patient occurred on Friday and the fourth coronavirus patient was treated on Saturday. These patients are under the care of the same leading medical center in the New York City area that treated the first and second patients.

The treatment with leronlimab is being administered under an emergency IND recently granted by the U.S. Food and Drug Administration (FDA). The treatment with leronlimab is intended to serve as a therapy for patients who experience respiratory complications as a result of contracting SARS-CoV-2 causing the Coronavirus Disease 2019 (COVID-19).

Bruce Patterson, M.D., CEO of IncellDx, a diagnostic partner and advisor to CytoDyn, said, IncellDx has developed specific companion diagnostic tests to determine the efficacy and dosing of leronlimab in these severe cases of COVID-19. We believe that leronlimab acts by enhancing the immune response while mitigating the cytokine storm that leads to morbidity and mortality in these patients.

Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn said, We are encouraged that the onsite medical team is reporting no safety issues and our team continues to be responsive and supportive in any way we can.

About Coronavirus Disease 2019SARS-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 it is unclear how easily the virus spreads. COVID-19 is thought to be transmitted 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. It is believed that symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure, and that symptoms in patients have ranged from non-existent to severe and fatal. At this time, there are very limited treatment options for COVID-19.

About Leronlimab (PRO 140) 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 successfully 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 can 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.

In the setting of cancer, research has shown that CCR5 plays an important role in tumor invasion and metastasis. 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. Additional research is being conducted with leronlimab in the setting of cancer and NASH with plans to conduct additional clinical studies when appropriate.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation and may be important 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 further support the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD and that blocking this receptor from recognizing certain 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 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 key 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 in 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 plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in the first quarter of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients and plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, 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 with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on leronlimab monotherapy remaining 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. 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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Two Additional Coronavirus Patients Treated at Leading New York Hospital with CytoDyn's Leronlimab, Bringing the Total to Four Patients - Associated...

Bone Marrow Stem Cells Comments Off on Two Additional Coronavirus Patients Treated at Leading New York Hospital with CytoDyn’s Leronlimab, Bringing the Total to Four Patients – Associated… | March 24th, 2020

Since 1998, advances incord bloodtechnology havemade cord blood transplantsa viable alternativeto traditional bone marrow transplantsin patients requiring astem cell transplant. While bone marrow transplants continue be a more commonprocedure, evidencesuggests this trendmay be changing. But is a cord blood transplant really a more effective procedure? The truth is, it depends on the circumstance.

Both bone marrow and cord bloodstem celltransplants are designed to replace unhealthy cells with healthy ones.

A bone marrow transplant involves the use of bone marrow that is transplanted from a donor into a recipient to cultivate new stem cells. Bonemarrow is a spongy tissue located inside the bones. Most commonly, bonemarrow is extracted fromthe breastbone, skull, hips, ribs or spine, as these contain stem cells that producewhite blood cells (leukocytes), which fight against infection; red blood cells (erythrocytes), which carry oxygen in order to eliminate waste from the organs and tissue; and platelets, which are responsible for making the blood clot. Bone barrow is removed from the donor under a general anesthetic. It isfiltered, treated, and either transplanted immediately into the recipient, or tested, frozen, and stored for later use.

Cord bloodis collected from a newbornsumbilical cord after delivery, so that it may be tested, frozen, and subsequently stored in acord blood bankfor future use.

There are many different criteria used to evaluate whether or not a cord blood transplant is right for you. When making your decision, it is important that both you and your doctor keep the following in mind:

In addition, cord blood transplants are generally better-suited for those younger than 30 years and, depending upon the quantity of available stem cells, may not be suited for patients over a certain weight. Bone marrow transplants, on the other hand, are not recommended for individuals with kidney, lung, liver, or heart conditions.

Sources

Cord Blood vs. Bone Marrow Transplants.Stem Cell Transplants: Bone Marrow vs Cord Blood. N.p., n.d. Web. 06 Feb. 2017.

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Bone Marrow vs. Cord Blood Stem Cell Transplant | Americord

Bone Marrow Stem Cells Comments Off on Bone Marrow vs. Cord Blood Stem Cell Transplant | Americord | March 23rd, 2020

DetailsCategory: DNA RNA and CellsPublished on Monday, 23 March 2020 16:33Hits: 250

GOSSELIES, Belgium I March 23, 2020 I BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces it has received regulatory approvals for its Clinical Trial Applications for the next studies of both of its lead candidates. These two studies are the pivotal JTA-004 PhaseIII clinical study targeting osteoarthritic knee pain and the PhaseIIb study of its allogeneic cell therapy product, ALLOB, in patients with difficult tibial fractures. The JTA-004 trial has been approved by regulatory authorities in Denmark, and the ALLOB by Belgian regulatory authorities.

Bone Therapeutics now has completed preparations for these trials. It is ready to initiate recruitment in both of these studies as soon as the current situation regarding COVID-19 allows, in those two countries. Bone Therapeutics has taken this decision to support healthcare systems in the respective trial countries, enabling them to concentrate on treating COVID-19 patients whilst necessary.

Bone Therapeutics is now ready to commence clinical trials on both its lead products. Receiving regulatory approvals for both Clinical Trial Applications completes the preparative activity for both studies, said Miguel Forte, CEO, Bone Therapeutics. This means that as soon as the current situation allows, we will be able to start recruiting patients for both clinical studies and continue to develop options for patients suffering knee osteoarthritic pain and difficult tibial fractures, both of which are conditions with a high unmet medical need.

The JTA-004 phase III study is a controlled, randomized, double-blind study. It will evaluate the potential of a single, intra-articular injection of JTA-004 to reduce osteoarthritic pain in the knee compared to placebo or Hylan G-F 20, the leading osteoarthritis treatment on the market. The study expects to enrol 676patients with mild to moderate symptomatic knee osteoarthritis in approximately 20centres in 7European countries and Hong Kong SAR.

The ALLOB Tibial Fracture PhaseIIb study is a randomized, double-blind, controlled study in which the fracture healing potential of ALLOB in patients with difficult fractures in the shinbone (tibia) will be evaluated and compared to standard of care alone after a follow-up period of 6 months. ALLOB will be applied by single percutaneous injection 24-72hours post reduction surgery in patients with fresh tibial fractures at risk for delayed or non-union. The study is expected to enrol approximately 178patients in approximately 40sites in up to 7European countries.

About JTA-004

JTA-004 is companys next generation of intra-articular injectable for the treatment of osteoarthritic pain in the knee. Consisting of a unique mix of plasma proteins, hyaluronic acid, a natural component of knee synovial fluid, and a fast-acting analgesic, JTA-004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain. In a phaseII study involving 164 patients, JTA-004 showed an improved pain relief at 3 and 6 months compared to Hylan G-F20, the global market leader in osteoarthritis treatment.

About Knee Osteoarthritis

Osteoarthritis (OA), also known as degenerative joint disease, is the most common chronic joint condition in which the protective cartilage in the joints progressively break down resulting in joint pain, swelling, stiffness and limited range of motion. The knee is one of the joints that are mostly affected by osteoarthritis, with an estimated 250M cases worldwide.

The prevalence of knee osteoarthritis (KOA) is expected to increase in the coming years due to increasingly aging and obese population. Currently, there is no cure for KOA and treatments focus on relieving and controlling pain and symptoms, preventing disease progression, minimizing disability, and improving quality of life. Most drugs prescribed to KOA patients are topical or oral analgesics and anti-inflammatory drugs. Ultimately, severe KOA lead to highly invasive surgical interventions such as total knee replacement.

About ALLOB and Bone Therapeutics proprietary, scalable cell therapy manufacturing process

ALLOB is the companys off-the-shelf allogeneic cell therapy platform consisting of human allogeneic bone-forming cells. These cells are derived from cultured bone marrow mesenchymal stem cells (MSC) from healthy adult donors. To address critical factors for the development and commercialization of cell therapy products, Bone Therapeutics has established a proprietary, optimized production process that improves the consistency, scalability, cost effectiveness and ease of use of the ALLOB platform. This optimized production process significantly increases the production yield, generating 100,000 of doses per bone marrow donation. Additionally, the final ALLOB product is cryopreserved, enabling easy shipment and the capability to be stored in a frozen form at the healthcare site. The process does therefore substantially improve product quality, reduce overall production costs, simplify supply chain logistics, increase patient accessibility and facilitate global commercialization compared to an autologous approach. Bone Therapeutics has implemented the optimized production process to produce clinical batches for the upcoming Phase IIb clinical trial in patients with tibial difficult-to-heal fractures.

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and bone diseases. The Company has a broad, diversified portfolio of bone cell therapies and an innovative biological product in later-stage clinical development, which target markets with large unmet medical needs and limited innovation.

Bone Therapeutics is developing an off-the-shelf protein solution, JTA-004, which is entering PhaseIII development for the treatment of pain in knee osteoarthritis. Positive PhaseIIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement. The clinical trial application (CTA) for the pivotal PhaseIII program has been approved by the Danish relevant authorities allowing the start of the study.

Bone Therapeutics other core technology is based on its cutting-edge allogeneic cell therapy platform (ALLOB) which can be stored at the point of use in the hospital, and uses a unique, proprietary approach to bone regeneration, which turns undifferentiated stem cells from healthy donors into bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery, and are produced via a proprietary, scalable cutting-edge manufacturing process. Following the CTA approval by the Belgian regulatory authority, the Company is ready to start the PhaseIIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process.

The ALLOB platform technology has multiple applications and will continue to be evaluated in other indications including spinal fusion, osteotomy and maxillofacial and dental applications.

Bone Therapeutics cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available at http://www.bonetherapeutics.com.

SOURCE: Bone Therapeutics

Excerpt from:
Regulatory authorities approve JTA Phase III study in osteoarthritic knee pain and ALLOB Phase IIb study in difficult fractures | DNA RNA and Cells |...

Bone Marrow Stem Cells Comments Off on Regulatory authorities approve JTA Phase III study in osteoarthritic knee pain and ALLOB Phase IIb study in difficult fractures | DNA RNA and Cells |… | March 23rd, 2020

VANCOUVER, Washington, March 23, 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, announced today that the third and fourth coronavirus patients were treated with the Company's investigational new drug, leronlimab. The treatment of the third patient occurred on Friday and the fourth coronavirus patient was treated on Saturday. These patients are under the care of the same leading medical center in the New York City area that treated the first and second patients.

The treatment with leronlimab is being administered under an emergency IND recently granted by the U.S. Food and Drug Administration (FDA). The treatment with leronlimab is intended to serve as a therapy for patients who experience respiratory complications as a result of contracting SARS-CoV-2 causing the Coronavirus Disease 2019 (COVID-19).

Bruce Patterson, M.D., CEO of IncellDx, a diagnostic partner and advisor to CytoDyn, said, "IncellDx has developed specific companion diagnostic tests to determine the efficacy and dosing of leronlimab in these severe cases of COVID-19. We believe that leronlimab acts by enhancing the immune response while mitigating the cytokine storm'that leads to morbidity and mortality in these patients."

Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn said, "We are encouraged that the onsite medical team is reporting no safety issues and our team continues to be responsive and supportive in any way we can."

About Coronavirus Disease 2019SARS-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 it is unclear how easily the virus spreads. COVID-19 is thought to be transmitted 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. It is believed that symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure, and that symptoms in patients have ranged from non-existent to severe and fatal. At this time, there are very limited treatment options for COVID-19.

About Leronlimab (PRO 140) 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 successfully 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 can 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.

In the setting of cancer, research has shown that CCR5 plays an important role in tumor invasion and metastasis.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. Additional research is being conducted with leronlimab in the setting of cancer and NASH with plans to conduct additionalclinical studies when appropriate.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation and may be important 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 further support the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD and that blocking this receptor from recognizing certain 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 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 key 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 in 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 plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in the first quarter of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients and plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, 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 with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on leronlimab monotherapy remaining 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. The Company's 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 Company's cash position, (ii)the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv)the Company's ability to enter into partnership or licensing arrangements with third parties, (v)the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Company's ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Company's clinical trials, (viii)the results of the Company's 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 Company's 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 Company's 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

Read more:
Two Additional Coronavirus Patients Treated at Leading New York Hospital with CytoDyn's Leronlimab, Bringing the Total to Four Patients - Benzinga

Bone Marrow Stem Cells Comments Off on Two Additional Coronavirus Patients Treated at Leading New York Hospital with CytoDyn’s Leronlimab, Bringing the Total to Four Patients – Benzinga | March 23rd, 2020