Personalized Stem Cells, Inc (PSC), a human adipose-derived stem cell company, has continued enrollment for participation in an FDA approved clinical trial for stem cell treatment of knee osteoarthritis. Though the trial never stopped, in-person visits were halted, and telemedicine was employed per the new FDA guidelines. New safety measures have been put in place by the doctors to meet the FDA’s recommendations to slow the transmission of the virus so the in-person visits may now resume.
The clinical trial, which was launched in September 2019, is studying the effects of autologous, adipose-derived stem cell therapy for knee osteoarthritis. Patients who were enrolled prior to the enactment of various nationwide stay-at-home orders continued to receive follow-up care from their physicians through phone calls or video conferences. With new social distancing measures in place, clinical trial investigators have resumed enrolling qualified patients for participation in the clinical trial. At this time, all enrollment is done through a select group of PSC qualified physicians.
This is the first of several planned clinical trials which will enable physicians to provide FDA compliant, quality cell therapy to patients suffering from osteoarthritis. PSC plans to conduct a series of FDA approved clinical trials starting with uses in orthopedics and expanding to other medical conditions in the future.
In addition, PSC recently submitted an expedited Investigational New Drug application to treat COVID-19 patients with stem cells. Upon FDA approval, PSC will launch a small clinical trial to study the effects of stem cell therapy on hospitalized COVID-19 patients. PSC CEO, Dr. Bob Harman, stated, “We expect to launch our first COVID-19 clinical trial in the coming weeks. We hope this trial will open the door for compassionate use of stem cells to treat additional patients suffering from COVID-19.”
PSC is not currently soliciting patients for inclusion in clinical trials. For more information regarding future clinical trials, contact PSC.