Stem Cell Clinic

Exploring the Utility of Stem Cell Therapy for COVID-19 – Technology Networks

Whilst the production of a safe and effective vaccine for SARS-CoV-2 is the ultimate aim of the COVID-19 response, research is also underway to develop novel treatments that could help infected patients in the meantime. One growing area of interest is the use of stem cell therapy: the results of two studies conducted in China indicate that its use seems to be particularly efficient in the case of severely ill patients, and theUS Food and Drug Administration recently authorized compassionate use of mesenchymal stem cell intravenous infusions in patients with a very dismal prognosis.To learn more about the science behind stem cell therapies andhow such a therapy would be produced and administered to COVID-19 patients,Technology Networksrecently spoke with Giuseppe Mucci, CEO, Bioscience Institute.

Anna Macdonald (AM): Can you explain some of the immunomodulatory effects stem cells can have and why this is particularly significant for COVID-19 patients?Giuseppe Mucci (GM):Mesenchymal Stem Cells (MSCs) are multipotent cells found in various locations in the body including adipose tissue, bone marrow, placenta and umbilical cord. These cells can be easily harvested, isolated, cultured and used in cell-based therapy, from basic research to clinical trials. Safety and effectiveness have been clearly documented in many clinical trials, especially in the immune-mediated inflammatory diseases, such as graft versus-host disease and systemic lupus erythematosus. MSCs play a positive role mainly in two ways, namely immunomodulatory effects and differentiation abilities. MSCs can secrete many types of cytokines by paracrine secretion or make direct interactions with immune cells, leading to immunomodulation.

The immunomodulation activity of mesenchymal stem cells was further confirmed in an interesting two-year-longclinical trialcarried out by the University of Miami, where the researchers used these cells for the treatment of frailty. We also know that the immunomodulatory effects of MSCs are triggered further by the activation of toll-like receptors in MSCs, which is stimulated by pathogen-associated molecules such as lipopolysaccharides or RNA from a virus, such as SARS-CoV-2.

Several reports demonstrated that the first step of COVID-19 pathogenesis is that the virus specifically recognizes, infects and destroys cells via two specific molecules, ACE2 and TMPRSS2. Unfortunately, the ACE2 receptor is widely distributed on the surface of human cells, especially lung alveolar cells, capillary endothelium and on some cardiac cells.

The immune system and its regenerative ability is compromised by age and, unfortunately, as we know very well, the elderly are strongly hit by this disease. Studies of the outbreak so far show that eight in 10 patients who are struck down with a severe case of coronavirus will be over 65. People under the age of 50 are supposed to have healthier immune systems than those who are older. This means their bodies should recognize an alien agent, such as the novel coronavirus, fairly quickly after it enters their cells and start producing antibodies to fight it.

Before the virus has had time to cause any of the serious breathing problems and nasty pneumonias in the lungs, their immune system should have fought it off, and they should be well on the road to recovery, suffering only a fever, dry cough and fatigue.

However, it is the youthful immune system that may become the problem in some subjects. As the immune system recognizes and prepares to attack the virus, small unknown and otherwise harmless genetic or environmental factors can cause the immune system to go into overdrive.

Inflammatory cells can release an excessive quantity of cytokines, which should help produce a hostile environment for the infection and sets off a chain event called a "cytokine storm". This is an over-reaction on the part of the immune system. This means thatthe immune system is unable to turn itself off once it has generated enough of a defence against the virus. Inflammation caused by the immune system continues at an unchecked and accelerated rate and floods the lungs with fluid, making it difficult to breathe. A prolonged cytokine storm will eventually shut down breathing completely.

Mesenchymal stem cells used in patients that have been affected by the cytokine storm may fine balance the immune system in order to stop the overreaction, without switching it off completely, so that the immune system can continue to fight the infection.

In elderly patients, MSCs may support the immune response as already proved by the Florida University trial and support the healing process absolutely necessary after the damage generated by the virus.

Molly Campbell (MC): The FDA has approved compassionate use of MSCs, specifically allogeneic (from a donor) stem cells. For our readers that may be unfamiliar with the approval processes, what does this mean?GM:Compassionatedruguserefers to the useof a new, unapproved drug to treat a seriously ill patient when no other treatments are available. To date, there is no specific cure for COVID-19. Clinical management of these patients currently includes prevention or control of the infection and supportive care, including supplemental oxygen and mechanical ventilation support when needed.

MSCs are recognized by the FDA as well as the European Medicines Agency (EMA) as a therapy that has already proven to be safe and in several cases effective in a number of American and European trials. Considering this and the early Chinese study reports regarding the efficacy of MSCs in the treatment of severe COVID-19 patients, FDA has granted compassionate use approval.

We can use MSCs obtained from your own tissue (autologous use) or from another individual's tissue (allogenic use). For several reasons, autologous use is the elective way, but considering that the production of the cells can take a considerable amount of time and we are currently in an emergency situation, if the patient has not already banked MSCs the only option is allogenic use. These cells can, in some way, evade the normal rules of self and not self that usually regulate the organ and tissue donation, and this allows allogenic use.

MC: Please can you tell us more about the results of the studies that have been conducted in China?GM:Two recent studies have taken place in China, and both studies reveal remarkable reversal of symptoms even in severe-critical conditions. The scientists have not only identified a novel therapeutic strategy, but also the existence of natural mechanisms able to counteract acute inflammatory pneumonia.

One study is a case reportof a critically ill COVID-19 patient on a ventilator who had progressed despite intensive therapy, with markers showing evidence of liver injury. This patient was treated with allogeneic MSCs using three intravenous infusions of 5x107MSCs, three days apart. Within four days of the patient's first cell infusion, she was off the ventilator and able to walk. All measured parameters, including circulating T cell counts, returned towards normal levels. No obvious side effects were observed.

The second study, the Beijing YouAn Hospital study, was a pilot clinical trial to assess whether MSC transplantation could improve the outcome of seven enrolled patients with clinical COVID-19 pneumonia, with one case determined as critically severe, four severe, and two non-severe. Before transplantation, all individuals had high fever, shortness of breath and low oxygen saturation. Treatment included a single intravenous dose of clinical grade MSCs, 1x106cells per kg of weight. Detailed follow-up over 14 days post-transplantation showed no adverse effects, and within two days all patients had significantly improved pulmonary function, including the one severe COVID-19 pneumonia case, who was well enough for discharge by day 10. Overall, after treatment, the immune system in a cytokine storm-like condition returned to a normal status.

MC: Please can you talk us through how a stem cell therapy would be produced and administered to COVID-19 patients?GM:MSCs can be isolated from several sources including adipose tissue, bone marrow, placenta, cord blood tissue etc. The harvested tissue is transferred to a Good Manufacturing Practice compliant cell factory where the cells of interest are isolated. The number of cells that can be isolated from the tissues is very low and not sufficient for therapeutic protocols, which require hundreds of millions of cells. That is why we need to expand them in a culturing process that normally requires two to four weeks. Once the cells are ready, the patient will receive the cell-based drugas intravenous infusions.

MC: Does data exist on which time-point post-infection the therapy would produce the highest efficacy?GM:At the moment, MSCs based therapy is used as emergency protocol mainly for the control of the cytokine storm when the patient is in a severe condition. However, as several studies have already shown, these cells can be used as a preventative treatment especially in the elderly patient.

MC: Are there safety implications to developing a stem cell therapy for treating COVID-19?GM:To claim that the development of a novel therapy, regardless of what it is, is free of risk is not scientifically and ethically correct. The data available at the moment has not reported side effects linked with the use of MSCs when the cells are produced by reliable groups with strong and validated quality systems.

Giuseppe Mucci, was speaking to Molly Campbell and Anna MacDonald, Science Writers, Technology Networks.

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Exploring the Utility of Stem Cell Therapy for COVID-19 - Technology Networks

Doctors think theyve discovered another potential coronavirus cure – BGR

The novel coronavirus might not have a cure right now, but its still worth acknowledging the massive research effort that goes into discovering treatments that can limit COVID-19 complications and prevent death. Doctors have observed the positive effects of a garden variety of drugs that are supposed to treat other illnesses, and some of these medicines are included in massive trials around the world. Scientists are also working on over 70 vaccine candidates for COVID-19, with some of them already showing promising results. On top of that, theres plasma from survivors thats rich in antibodies that can help people with weaker immune systems. And doctors think theyve discovered another promising treatment for COVID-19: Stem cells.

You often hear about stem cells and those reports are often miraculous in nature. Stem cells are human cells that have the superpower to transform into almost any cell of the body and they can be used to treat some medical conditions. Stem cells could regenerate lung tissue, fight inflammation, and help severe COVID-19 patients breathe on their own again. The problem with this line of thinking is that we just dont know.

Doctors at Mount Sinai treated 12 patients with stem cell therapy, and 10 of them came off their ventilators soon after, CBSNews reports. The doctors themselves have no idea what helped the patients improve, and cant definitively say that its the stem cells that saved their patients.

What we saw in the very first patient was that within four hours of getting the cells, a lot of her parameters started to get better, Dr. Karen Osman told CBS. The doctor made it clear that they cant claim the stem cell treatments are what saved the patients. We dont know, she said. And we would never dare to claim that it was related to the cells.

The doctor explained that only a randomized controlled trial would be able to tell them whether the stem cells can help with the recovery of COVID-19 patients. Thankfully, one such study is about to get underway. Mesoblast will trial stem cell treatments on 300 patients suffering from severe lung inflammation.

Osman and her team believe that stem cells extracted from bone marrow could suppress the inflammation in COVID-19 patients, and thats why they attempted the therapy. One such patient was 60-year-old Luis Naranjo who spent 14 days unconscious on a ventilator and lost 25 pounds while hospitalized of COVID-19. Naranjo has completely recovered following stem cell therapy, and hes at home working on regaining his strength.

If it works, stem therapy would still not be a miracle treatment, Osman says. The miracle treatment will be a vaccine. While we wait for any sort of efficient COVID-19 treatment, heres a simple explainer for stem cells:

Image Source: Darko Vojinovic/AP/Shutterstock

Chris Smith started writing about gadgets as a hobby, and before he knew it he was sharing his views on tech stuff with readers around the world. Whenever he's not writing about gadgets he miserably fails to stay away from them, although he desperately tries. But that's not necessarily a bad thing.

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Assessing the Fallout From the Coronavirus Pandemic Value of Canine Stem Cell Therapy Market Predicted to Surpass US$ by the of 20512019-2019 -…

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Analysis of the Global Canine Stem Cell Therapy Market

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Stem Cell Cartilage Regeneration Market 2020: Production, Sales, Supply, Demand, Analysis and Forecast To 2026 – Cole of Duty

The Stem Cell Cartilage Regeneration market demand is anticipated to flourish during the forecast period 2020-2027. The report offers information related to import and export, along with the current business chain in the market at the global level. This report provides an in-depth overview of the Stem Cell Cartilage Regeneration market. This includes market characteristics, consisting of segmentation, market share, trends and strategies for this market. The Market Size section provides historical forecasts of market growth and future. An in-depth analysis of the major companies operating in the market is also mentioned in this research report.

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Stem Cell Cartilage Regeneration Market 2020: Production, Sales, Supply, Demand, Analysis and Forecast To 2026 - Cole of Duty

Covid has proved we havent spent enough on life science research. Time to make up now – ThePrint

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Indias life sciences sector, including pharmaceuticals, diagnostics, medical devices, clinical research, and digital health, has been at the forefront of our battle against the coronavirus pandemic. Domestic pharma companies are developing drugsandvaccines.Some have alsodeveloped testsand are rolling out testingservices. Indias hydroxychloroquine is being exported around theworldand is in great demandto aid the treatment of Covid patients.

Meanwhile, the Aarogya Setu contact tracing app has alreadyseenmore than 7.5 croredownloads.

We must now further strengthen the life sciences sector to meet the demands of the future. This will require a multi-dimensional approach.

Also read: To achieve herd immunity, vaccine and a data-driven approach needed: WHO chief scientist

First. There must beclose industry-government collaboration to develop and fine-tune regulations to promote fast growthfor the sector.

Second. We must ensure that we rapidly build up our life sciences workforce so that we can have enough talented people available for both the health care and the life sciencessectors.

Third. We should consider whether we are providing enough financial support for sectoral growth.

And, finally, we must leverage the fast-emerging IndianSuperCloudto connect all our life sciences activity.

Some of our life sciences enterprises are nowworld leaderssuch as Cipla, Aurobindo, Lupin, and DRL.Some 50per centof the worlds vaccines are produced in India. We also produce 20per centof the worlds generic medicines. The pharma industry alone generates close to $20 billion inannual exports.

Our skilled doctors, nurses, and other life sciences professionals are leading major research programmes in India and around the world. The coronavirus pandemic has proven to all of us that we have not been spending enough on life sciences and health care.

Resources and spending willneed togrow dramatically to protect the worlds population. Life sciences companies should now work closely with our various regulators and policy-makers throughempowered working groups to driveupinvestment, growth, and jobs.

Also read: Made-in-India Covid-19 vaccine could be ready in a year, says Biocons Kiran Mazumdar-Shaw

Life sciencesisa tightly regulated sector. In India, we have several regulators across multiple ministries that have oversight over the sector.

The National Pharmaceutical Pricing Authority (NPPA) sets prices for bulk drugs and formulations and is within the ministry of chemicals and fertilisers. The ministry of health and family welfare manages the safety, efficacy, and quality of drugs and medical devices through the Central Drugs Standard Control Organisation. In the same ministry, the National Health Portal of India is formulating Electronic Health Record (EHR) standards, which will also be governed by the Personal Data Protection bill, being handled by the ministry of electronics and information technology.

Alllife sciences research is conducted under the guidelines established by the Indian Council of Medical Research and the Ministry of Science & Technology. The Ayush Ministry and Niti Aayog also play an important role in the life sciences sector.Although healthis a state subject and each state can develop policies to support the sector,it is important thatall these regulators anddecision-makers,both at the centre and the state level, working with industry,developcoordinatedresponse forsectoral growth.

Also read: Covid-19 response is a chance for companies to place planet over profits

Along with deep collaboration between industry and government at all levels, we must also build up our life sciences workforce. Today we have 535 medical colleges in India graduating about 79,000 students every year. It is estimated that we currentlyhave 300,000 annualnursing seatsavailable. In addition, there are lakhs of biology, biotechnology, and chemistry students graduating every yearwhocan be employed in the life sciences sector.

That said, we still have only 0.7 doctors per 1,000 people against the minimumWorld Health Organizationsstandard of 1 per 1000 people. For nurses, we are at 1.7 when we should be at 2.5. In addition, we need to provide our educational institutions withsignificantly higherresearch funding so that we can get more young scientists and researchersto work towards developingcutting-edgesolutionsin drugs,devices, andtherapiessegments.

Also read: Critical drugs supply must not be disrupted, EU envoy says as India bans & resumes exports

Government funding worththousands of crores of rupees is required to drive this researchculture in India. An expert panel could be constituted to select 10-15 researchareassuch as genomics, computational biology, virology, epidemiology, neuroscience, stem cell research, etc.

Multi-year research grants could then be provided to top scientists (in India or from ourcommunity abroad) to pursue their research and train graduate students. Research productivity could then be judged on objective global metrics (high-quality citations, placement of graduate students in top institutions, and so on) to ensure accountability and quality.

We also need to back new life sciences enterprises with venture capital financing. The government has established a Rs 10,000 croreFund-of-Fundsto support venture capital funds. It might be possible to allocate a significant fraction of this money solely to life sciences funds, so that they can provide the necessary financing and support to life sciences startups. This will require that SIDBI have the necessary expertise toidentifyand nurture life sciences funds.

Also read: US drug authority warns Americans not to pop hydroxychloroquine pills without prescription

Finally, Indias fast-emerging SuperCloud can play an important role in the development of the life sciences sector. With high-speed 5G networks and local data centres, telemedicine and remote diagnostics will become fully feasible.

Theprovisions of thenew Personal Data Protection bill will make it possible to develop a secureelectronic health record (EHR)for every individual so that their necessary healthcare eligibility, data, and payments/insurance are available as required. Large local data lakes will enable AI and computational biology to develop therapies targeted for the Indian genome.

Pandemics will come and go,but ournon-communicable disease burden will continue to rise. Around the world, there is a looming shortage of skilled medical professionals and researchers. New, low-cost therapies are in high demand. The Indian life sciences sector can take advantageof these circumstancesto not only protect our health, but also become a growth engine for Indias economy.

Jayant Sinha is the Chairman of the Standing Committee on Finance in Parliament and a Lok Sabha MP from Hazaribagh, Jharkhand. These are his personal views.

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Covid has proved we havent spent enough on life science research. Time to make up now - ThePrint

COVID-19: Potential impact on Amniotic Fluid Stem Cell Therapy Market Forecasted To Surpass The Value Of US$ XX Mn/Bn By 2060 2018 2026 – Latest…

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key players operating in global amniotic fluid stem cell therapy market are Stem Shot, Provia Laboratories LLC, Thermo Fisher Scientific Inc. Mesoblast Ltd., Roslin Cells, Regeneus Ltd. etc. among others.

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COVID-19: Potential impact on Amniotic Fluid Stem Cell Therapy Market Forecasted To Surpass The Value Of US$ XX Mn/Bn By 2060 2018 2026 - Latest...