CoronaStem : COVID-19 Clinical Trials
Coronavirus disease (COVID-19) is a global pandemic that is threatening the health and welfare of the entire world. Treatment options are needed now. The White House Coronavirus Task Force asked PSC to file for accelerated FDA approval for our first study, CoronaStem 1. We immediately submitted our FDA request and expect rapid review and approval. As CoronaStem 1 gets launched (expected in May, 2020), we will ask FDA for approval for treatment of a larger and wider group of patients in need.
Why Stem Cells for COVID-19?
- Stem cell therapy is one of the few approaches that directly treats the lung inflammation of the most serious COVID-19 patients
- Recent publications report strikingly positive outcomes from treating COVID-19 patients with stem cells (China, Israel)
- Published studies show reduction in death loss and reduced ventilator need
- PSC has FDA-inspected stem cell manufacturing facilities already producing stem cells
CoronaStem 1 Clinical Trial
- This first study is only in a single hospital in California and limited to 20 serious patients
- Please do not request enrollment information at this time as the limited enrollment will
be done at the hospital from existing hospitalized COVID-19 patients. We will post
information here as we expand.
- Clinical Trial Design
- 20 patient Phase 1 study – one hospital
- IV treatment of hospitalized serious COVID-19 patients
- Stem cells are from disease-free donors manufactured in FDA facilities
- Three doses will be given over several days by simple IV infusion
- 56-day study – measures reduction in days in the ICU, reduction in ventilator use, safety, lung function
- Mesenchymal Stem Cell (MSC) Therapy for COVID-19 and Acute Respiratory Distress Syndrome(ARDS)
- Rationale for the clinical use of adipose‑derived mesenchymal stem cells for COVID‑19 patients
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