Personalized Stem Cells, Inc. (PSC) has filed a request for expedited review of an FDA Investigational New Drug (IND) for the treatment of COVID-19 patients with stem cells. The White House Coronavirus Task Force asked PSC to apply through the new FDA Coronavirus Therapeutic Accelerator Program, which functions to expedite the approval and launch of new FDA-approved clinical trials for promising COVID-19 therapies.
Stem Cells for the Treatment of COVID-19
In recent news stories out of Israel, China, and the United States, stem cells have shown promising effectiveness in the treatment of the major medical lung issues caused by COVID-19. Israel recently announced 100% recovery in seven COVID-19 patients who were treated with stem cells. Similar results are reported in China from PSC’s collaborators in Wuhan and Beijing.
PSC is using this front-line hospital experience from Chinese physicians to create the best treatment protocol possible for its U.S. clinical trials. PSC Medical Director, Dr. Chris Rogers, stated, “I believe this is the most promising therapy being explored by medical scientists at this time. Stem cells may potentially reduce the most serious complications of coronavirus infection.”
PSC’s COVID-19 Clinical Trial – Pending FDA Approval
The first trial will be termed “CoronaStem 1” and will provide treatment for twenty hospitalized COVID-19 patients with serious complications. PSC hopes to rapidly complete the CoronaStem 1 study and then proceed into a larger Phase 2 clinical trial and potentially into FDA compassionate use programs to reach more patients.
PSC has already scaled up production of stem cells in its San Diego FDA-inspected stem cell manufacturing facilities in order to be ready to supply stem cells for patient treatment. PSC is not currently soliciting patients for inclusion in the CoronaStem 1 trial however additional capital is necessary to further ramp up production of stem cells.
How can you help?
More stem cell technicians and critical supplies are needed to increase stem cell production. Calidi Biotherapeutics has collaborated with PSC by providing needed cell lines and supplies to speed stem cell manufacturing, but money is also needed to pay the doctors, nurses, hospitals, imaging technicians, laboratories and others involved in performing the medical procedures for the clinical trial.
PSC has partnered with The San Diego Foundation, a 501c3 organization, to take in donations of any size to be focused on providing as many stem cell doses to as many COVID-19 patients as possible. The use of a 501c3 foundation allows the donations to be tax deductible, and the Foundation has generously offered to handle these donations with no management fees.
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