Trial to Test Stem Cells for Covid-19 Prevention

Scanning electron microscope image of SARS-Cov-2 virus, responsible for Covid-19 infections (NIH.gov)

26 June 2020. A company that collects and stores a person’s own stem cells for therapies later on says FDA cleared a clinical trial of donated stem cells to prevent Covid-19 infections. Celltex Therapeutics in Houston says the U.S. Food and Drug Administration approved its application to conduct a clinical trial of a donor’s own stem cells among individuals considered at high risk of infection from SARS-CoV-2 viruses.

Celltex Therapeutics specializes in producing and storing individuals’ mesenchymal stem cells, adult stem cells derived from bone marrow and other soft tissues that can transform into a variety of skeletal and other tissue types. The company developed a process for extracting mesenchymal stem cells from a person’s adipose or fat tissues, then producing and storing large quantities of those stem cells for future regenerative therapies, if needed by that individual. The company says these banked stem cells can be used to treat vascular, autoimmune, and degenerative diseases.

The company reported in March 2020 on results of mesenchymal stem cell treatments in seven patients in Beijing, China with pneumonia symptoms experienced after Covid-19 infections. Those findings, published in the journal Aging and Disease, show the patients’ respiratory functions improved without adverse effects. In addition, the patients receiving the stem cell transplants had fewer damaging cytokine or enzyme releases than a comparison group receiving conventional therapies.

In addition, Celltex says it serves some 1,500 clients who received more than 9,000 therapies for various diseases without adverse effects. Among the diseases treated by clients’ own stem cells are acute respiratory distress syndrome and inflammatory lung disease experienced by some Covid-19 patients, as well as influenza, and other viruses similar to Covid-19.

Celltex says it received an approved investigational new drug application, or IND, from FDA, in effect, authorization from the agency to begin clinical trials. The company’s mid-stage trial is enrolling 200 individuals who previously donated and banked their stem cells with Celltex. The study is focusing particularly on persons with conditions making them at high risk of Covid-19 infections: obesity, high blood pressure, diabetes, or chronic heart, pulmonary, liver, or kidney disorders.

Participants are randomly assigned to receive three infusions with 200 million of their own adipose-derived mesenchymal stem cells, or MSCs, or an equivalent volume of placebo, every three days. Individuals are then monitored for six months. The study team is looking primarily for adverse effects from the stem cells during this period as signs of safety or tolerability issues, but also for occurrences of Covid-19 infections among participants. Researchers are likewise tracking development of antibodies among participants, as well as immune-system cytokines and inflammatory proteins.

David Eller, Celltex’s chairman and CEO, says in a company statement released through BusinessWire that “FDA’s approval of our IND is not only a critical milestone for Celltex, but also for everyone who has been affected by Covid-19.” Eller adds that “throughout the entire pandemic, MSCs have shown promise for combating symptoms and complications associated with Covid-19….”

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• Enrollment Completed in Aging Frailty Stem Cell Trial

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