Can Stem Cell Therapy Help against COVID-19? (Updated)

The number of confirmed cases of the 2019 novel coronavirus (2019-nCoV) reported to WHO continues to rise worldwide. Although WHO has launched a global megatrial to test 4 most promising treatments, there is currently no specific proven anti-viral treatment exists. Although there are some published studies for various promising treatments from antivirals, anti-malarial to anti-oxidants, the studies are small and yet to be confirmed. The mainstay of clinical management is largely symptomatic treatment, with organ support in intensive care for seriously ill patients.

WHO and other global public health bodies have mainly focused on preventing transmission, infection control measures, and screening of travellers. The development of vaccines has received immediate funding; however, as with SARS-CoV and MERSCoV, support for developing treatments for 2019-nCoV that reduce mortality has not been forthcoming. All three coronaviruses induce excessive non-effective host immune responses that are associated with severe lung damage, leading to death. In most patients who are severely affected, COVID-19 infection is also associated with a 'cytokine storm' or severe inflammatory response.

The term 'cytokine storm' was popularized largely in the context of avian H5N1 influenza virus infection, bringing the term into popular media.

is stem cell therapy legal in malaysia

The human umbilical cord mesenchymal stem cells (hUCMSCs) have shown very good capability to modulate immune response and repair the injured tissue with good safety (PubMed).

new pilot study which was a small study of 7 patients who were given 50-100 million, culture-expanded MSCs. 5/7 of the patients had severe COVID-19 cases and two just had viral pneumonia (common type). The two common type patients were recovered and discharged and the other four were listed as recovered but seem to have still been in the hospital at the time the paper was submitted. Three severe cases were recruited for the placebo group and the outcomes were that one died, one still was in respiratory distress (ARDS), and one was listed as stable. The treated patients showed a decrease in the inflammatory cytokine storm so prevalent in COVID-19.

Here, we have compiled and updated a few significant studies, clinical trials and related reviews and news on Coronavirus treatment with stem cell therapy.

There are multiple on-going studies on COVID-19 and stem cell therapy on the US Clinical Trials Register and the Chinese Clinical Trials Register. However, most of them are small in terms of size and design. However, we have shortlisted below a few clinical trials that are reasonable in terms of design and size and will be the trials to watch out for.

This list is a work-in-progress list as new evidence might be added from time to time.

FDA approves COVID-19 trial after successful emergency use of umbilical stem cells from RESTEM (May, 2020)

RESTEM, a leading cell-based therapeutics company, announced today it has received approval from the U.S. Food and Drug Administration (FDA) for a 60-patient Phase I/IIa study using umbilical cord mesenchymal stem cells to treat patients with severe cases of COVID-19. The study will be the first of its kind in the U.S.

"We are excited to launch this study and demonstrate the potential of our patented umbilical cord lining stem cell (ULSC) technology," said Dr. Rafael Gonzalez, senior vice president of research & development for RESTEM.

The multicenter phase I/IIa study, officially known as the Systemic Umbilical Cord Cells to Ease Severe Syndrome with COVID-19 (SUCCESS) trial, will be completed in collaboration with Baptist Health South Florida in Miami, Florida and Sanford Health in Sioux Falls, South Dakota, for COVID-19 patients who have developed ARDS.

This study will be a collaborative effort between multiple institutions including Florida International University Herbert Wertheim College of Medicine, Baptist Health South Florida, Sanford Health, and a biotechnology lab, RESTEM.

Patients will be able to participate in the SUCCESS clinical trial both at Miami Cancer Institute and at Sanford Health.

Read more: https://www.biospace.com/article/releases/fda-approves-covid-19-trial-after-successful-emergency-use-of-umbilical-stem-cells-from-restem/


Stem cells tested as potential therapy for coronavirus in trial at University of Maryland medical school (May 2020)

Researchers at the University of Maryland School of Medicine are participating in a trial of an experimental stem cell therapy for some of the sickest COVID-19 patients who are on ventilators.

The study is one of many going on in Maryland and elsewhere that are testing existing drug therapies, as well as new ones, to treat the disease caused by the coronavirus.

This drug was developed by Mesoblast Ltd., an Australian company that develops cell therapies. It is designed for those with moderate to severe cases of severe acute respiratory distress syndrome, called ARDS. The trial will assess whether it shortens recovery time and reduces death from COVID-19.

Remestemcel-L was developed for various inflammatory conditions, and researchers say it could reduce COVID-19 related inflammation by reducing the production of pro-inflammatory chemicals called cytokines.

A preliminary study in 12 patients on ventilators at Mount Sinai Hospital in New York found that 10 of them survived and nine were removed from the ventilators in a median of 10 days, Mesoblast announced in late April. The compassionate-use study involved two infusions of remestemcel-L, and the results were significantly better than in the patient pool in other hospitals in hard-hit New York City at the time, the company said.

“The remarkable clinical outcomes in these critically ill patients continue to underscore the potential benefits of remestemcel-L as an anti-inflammatory agent,” said Dr. Silviu Itescu, Mesoblast’s CEO, in a statement at the time. "We intend to rapidly complete the randomized, placebo-controlled Phase 2/3 trial in COVID-19 ARDS patients to rigorously confirm that remestemcel-L improves survival in these critically ill patients.”

The first patient in that next study was enrolled at the University of Maryland Medical Center. The trial aims to enroll 300 patients at up to 30 sites, including university system hospitals and other U.S. sites, over the next three or four months. If the drug appears to be working well or not working at all, the trial could end early. The drug could cause negative immune system reactions, researchers said.



Coronavirus: Stem-cell treatment hailed a 'game-changer' in fight against deadly bug (May 2020)

A new coronavirus treatment has been hailed a ‘game-changer’ in the fight against COVID-19.

The treatment was developed by a team at the Abu Dhabi Stem Cell Centre, and involves extracting stem cells from the patient’s own blood, activating them, and reintroducing them to the patient.

Hend Al-Otaiba, Director of Strategic Communications at the UAE Ministry of Foreign Affairs and International Cooperation, said: “A UAE research institute has developed a breakthrough treatment for COVID-19 which could be a game-changer in the global fight against the virus.”

So far, the treatment has been administered to 73 coronavirus patients, who inhaled the activated stem cells into their lungs.

Amazingly, all 73 patents were successfully treated and made a full recovery.

In a statement about the research, the team explained: “It is hypothesised to have its therapeutic effect by regenerating lung cells and modulating the immune response to keep it from overreacting to the COVID-19 infection and causing further damage to healthy cells.”

Thankfully, none of the patients who received the treatment reported any immediate side effects.

The team now plans to continue trials to demonstrate the efficacy of the treatment, and expects these tests to be completed in a couple of weeks.

The researchers added: “It is worth noting that the treatment has been given to patients along with the conventional medical intervention and will continue to be applied as an adjunct to established treatment protocols rather than as a replacement.”

Read more: https://www.mirror.co.uk/science/coronavirus-stem-cell-treatment-hailed-21970439


University of Miami Treats COVID-19 Patients with MSC Stem Cells (Apr 2020)

For COVID-19 patients in severe respiratory distress, the University of Miami Miller School of Medicine now offers access to mesenchymal stem cell (MSC) treatments that may help fight the characteristic inflammation that accompanies the viral infection.
On April 5, the U.S. Food and Drug Administration (FDA) approved MSC treatments for seriously ill COVID-19 patients as an “expanded access compassionate use.” Since then, UM has provided clinicians in Miami and Maryland with MSCs taken from bone marrow and cultured at the Interdisciplinary Stem Cell Institute (ISCI) manufacturing lab. Six COVID-19 patients with serious breathing difficulties have shown improvement after receiving MSC infusions along with other treatments. The sixth patient, who was on ECMO, was recently injected at Jackson Memorial Hospital.

“Early reports from China indicated that MSCs could be helpful in treating COVID-19 patients in severe respiratory distress,” said Jose Guillermo Castro, M.D., professor of infectious diseases at the Miller School and director of the antibiotic stewardship program at UHealth Tower. “We offer that form of therapy through ISCI and are cautiously optimistic that it can be helpful.”

Khan said ISCI is making both bone marrow and umbilical cord-derived MSCs available for treating COVID-19 patients throughout South Florida. The FDA recently approved a clinical trial led by UM’s Diabetes Research Institute and Cell Transplant Center that will test the safety and effectiveness of umbilical cord-derived MSCs.

“Our staff members are working night and day to build our inventory, and we now have the ability to treat about 50 patients,” Khan said. “We plan to continue growing our inventory because the need for COVID-19 treatments is so great.”

Read more: https://www.newswise.com/coronavirus/university-of-miami-treats-covid-19-patients-with-msc-stem-cells


First COVID-19 patient in Texas enrolled in UTHealth stem cell therapy study at Memorial Hermann (Apr 2020)

The first COVID-19 patient in Texas has been enrolled in a stem cell therapy clinical trial for acute respiratory distress syndrome (ARDS) at The University of Texas Health Science Center at Houston (UTHealth).

The procedure took place April 16, 2020, at Memorial Hermann-Texas Medical Center.

The Phase IIb randomized trial uses allogenic, bone marrow-derived mesenchymal stromal cells (hMSCs), which have been shown in preclinical trials to help regulate the immune response, lowering inflammation and reducing the severity of organ injury.

“Mesenchymal stem cells have the ability to modulate the inflammatory response that plays a key role in the development of ARDS. This makes them a very promising therapy for treating patients with the severe respiratory failure we are seeing in COVID-19 patients,” said Laura J. Moore, MD, co-principal investigator of the Texas site of the national trial and professor in the Department of Surgery with McGovern Medical School at UTHealth.

“This represents another translation of cell-based therapies at UTHealth," Cox said. "The unifying theme of this approach is the dampening of the immune response to injury.”

UTHealth co-investigators include Cox; Lillian Kao, MD; Charles Wade, PhD; and Erin Fox, PhD. Wade is the James H. “Red” Duke, Jr., MD, Distinguished Professor in Surgery. Kao is the Jack H. Mayfield, MD, Chair in Surgery and division director of Acute Care Surgery. Fox is associate professor in the Center for Translational Injury Research.



Coronavirus: critically ill Chinese patient saved by stem cell therapy, study says (Mar 2020)

A 65-year-old Chinese woman who fell seriously ill after being infected with the coronavirus made a startling recovery after being given stem cell therapy, according to a new study by Chinese scientists.

The patient had been fighting for her life in the intensive care unit at Baoshan Hospital in Kunming, the capital of southwest China’s Yunnan province, for nearly two weeks after contracting Covid-19, the disease caused by the virus.

But according to a paper published by a team of researchers from Kunming University led by Dr Hu Min, just four days after being given her first shot of umbilical cord stem cells, the woman was back on her feet and able to walk.

“Although only one case was shown here, it could be very important and inspire similar clinical practices in treating critically ill Covid-19 patients,” said the study, which was published on Thursday on Chinaxiv.org, a platform for the release of scientific papers that have yet to be peer-reviewed.

The Yunnan case is one of 14 trials using stem cells to treat coronavirus patients in China, according to the World Health Organisation’s clinical trial database. While the technology remains controversial, there is hope among health authorities and medical professionals that it could become a lifesaver for critically ill patients.

According to Dr Li Honghui, who is involved in similar trials at Loudi Central Hospital in central China’s Hunan province, stem cell injections can deliver significant results within three days.

“We cannot stick to the rules, we must be bold and innovative,” he was quoted as saying in a report by Hunan Daily last week.

Another paper published on Chinaxiv on Friday said that seven coronavirus patients in Beijing had been given stem cell therapy and responded in a similar way to the woman in Kunming.

Stem cell technology emerged in the 1980s but remains highly controversial. Scientists initially considered using human embryos as the source for the cells, but the idea drew fire on ethical grounds.
The research community responded by proposing alternative methods for harvesting stem cells, such as turning normal tissue cells into stem cells, but those efforts were tarnished by a series of scandals in the United States, Japan and South Korea involving the fabrication of experimental data.

In China, scientists are engaged in cutting edge research on stem cells. While the use of cells from healthy embryos is forbidden, scientists are permitted to use fertilised eggs discarded due to illness or defects.

A doctor treating coronavirus patients in Beijing, who asked not to be named, said there was a growing discussion within the medical community about the potential benefits of stem cell therapy.

“The stem cell industry may have some vested interest to promote their technology in this crisis, but if it really works, it should be made available to more patients,” she said.

Read more: https://www.scmp.com/news/china/society/article/3053080/coronavirus-critically-ill-chinese-patient-saved-stem-cell


Treatment With Mesenchymal Stem Cells for Severe Corona Virus Disease 2019(COVID-19)

URL: https://clinicaltrials.gov/ct2/show/NCT04288102

Sponsor: Beijing 302 Hospital (China)

Description:

The epidemic of 2019 novel coronavirus (causing the disease Covid-19) has expanded from Wuhan throughout China and is being exported to a growing number of countries, some of which have seen onward transmission. COVID-19 caused clusters of severe respiratory illness and was associated with 2% mortality. There is currently no vaccine and no specific antiviral treatment recommended for COVID-19. About 20% of the patients were severe and the mainstay of clinical management is largely symptomatic treatment, with organ support in intensive care for seriously ill patients. Therefore, it is urgent to find a safe and effective therapeutic approach to COVID-19. 

In the last years, the promising features of mesenchymal stem cells (MSCs), including their regenerative properties and ability to differentiate into diverse cell lineages, have generated great interest among researchers whose work has offered intriguing perspectives on cell-based therapies for various diseases. These findings seem to highlight that the beneficial effect of MSC-based treatment could be principally due by the immunomodulation and regenerative potential of these cells. MSCs could significantly reduce the pathological changes of lung and inhibit the cell-mediated immune inflammatory response induced by influenza virus in animal model . MSCs have been shown to reduce nonproductive inflammation and affect tissue regeneration and is being evaluated in patients with ARDS (acute respiratory distress syndrome). Our phase I preliminary data of parallel assignment study(NCT04252118) showed that three doses of MSCs was safe in patients with COVID-19. Randomized control trial (RCT) are needed to assess efficacy and safety.

The investigators will do a prospective, double-blind, multi-centre, randomised trial to assess treatment with three intravenous doses of MSCs compared with placebo. 90 severe COVID-19 patients will be recruited in China. 60 patients will receive i.v. transfusion 3 times of MSCs (4.0*10E7 cells per time), as the treated group, all of them receive the conventional treatment. As control, 30 patients will receive placebo and conventional treatment.


Therapy for Pneumonia Patients iInfected by 2019 Novel Coronavirus

URL: https://clinicaltrials.gov/ct2/show/NCT04293692

Sponsor: Puren Hospital Affiliated to Wuhan University of Science and Technology (China)

Description:

Since late December 2019, human pneumonia cases infected by a novel coronavirus (2019-nCoV) were firstly identified in Wuhan, China. As the virus is contagious and of great epidemic, more and more cases have found in other areas of China and abroad. At present, there is no effective treatment for patients identified with novel coronavirus pneumonia. Therefore, it's urgent to explore more active therapeutic methods to cure the patients.

Recently, studies on the 2019 novel coronavirus pneumonia published in The Lancet and The New England Journal of Medicine suggested that massive inflammatory cell infiltration and inflammatory cytokines secretion were found in patients' lungs, alveolar epithelial cells and capillary endothelial cells were damaged, causing acute lung injury. It seems that the key to cure the pneumonia is to inhibit the inflammatory response, resulting to reduce the damage of alveolar epithelial cells and endothelial cells and repair the function of the lung.

Mesenchymal stem cells (MSCs) are widely used in basic research and clinical application. They are proved to migrate to damaged tissues, exert anti-inflammatory and immunoregulatory functions, promote the regeneration of damaged tissues and inhibit tissue fibrosis. Studies have shown that MSCs can significantly reduce acute lung injury in mice caused by H9N2 and H5N1 viruses by reducing the levels of proinflammatory cytokines and the recruitment of inflammatory cells into the lungs. Compared with MSCs from other sources, human umbilical cord-derived MSCs (UC-MSCs) have been widely applied to various diseases due to their convenient collection, no ethical controversy, low immunogenicity, and rapid proliferation rate. In our recent research, we confirmed that UC-MSCs can significantly reduce inflammatory cell infiltration and inflammatory factors expression in lung tissue, and significantly protect lung tissue from endotoxin (LPS) -induced acute lung injury in mice.

The purpose of this clinical study is to investigate safety and efficiency of UC-MSCs in treating pneumonia patients infected by 2019-nCoV. The investigators planned to recruit 48 patients aged from 18 to 75 years old and had no severe underlying diseases. In the treatment group, 24 patients received 0.5*10E6 UC-MSCs /kg body weight intravenously treatment 4 times every other day besides conventional treatment. In the control group, other 24 patients received conventional treatment plus 4 times of placebo intravenously.


Wrap-Up

Stem cell therapy is not a cure all therapy and is still under evaluation. If you have no symptom or mild symptoms, you might not need any treatment. If you have severe symptoms or have risk factors (elderly, hypertension, diabetes mellitus, asthma etc.), you should see your family doctor or hospital ER (open 24 hours a day 7 days a week) about what to do next.

Most of the treatments under evaluation are hospital based treatments and need to be prescribed by qualified doctors. Do not self-medicate. A couple in Arizona mistakenly thought that a popular fish tank additive that has chloroquine was safe to ingest. It was not and this stuff ended up killing him with his wife in the ICU. Hence, please be careful out there!

If you are worried about the latest Coronavirus or COVID-19, there are several things you can do (and not do) to improve your immune system. Check out best supplements to boost your immune system. Your immune system is your first line of defence against the coronavirus, not the treatments you would get from the hospitals. That's your last line of defence.


Read more: Coronavirus

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