PSC announces First Patients Treated in FDA Approved Clinical Trial for Treatment of Osteoarthritis with Stem Cells
Personalized Stem Cell Inc (PSC) received FDA approval to test toward an (IND) application. If successful, any individual patient would be able to use his/her own stem cells for osteoarthritis is a controlled and standardized way. Moreover, (PSC) has started with many sites testing 125 patients with this medical condition. Clinical trial sites include patients in San Diego and Los Angeles California, Portland Oregon, Chicago Illinois, and New Jersey.
PSC CEO, Michael Dale, stated, “We are pleased with the response from patients who suffer from knee arthritis and with the diligence and enthusiasm of the participating clinics around the country. We expect to rapidly increase enrollment in this first clinical trial as we prepare for additional clinical trials using stem cells for orthopedic injuries.”
Indeed, it is the first of many trials so that doctors can provide high quality treatment with FDA approval. Besides, the data suggests that beyond osteoarthritis, the therapy can be used for orthopedic conditions and more.
Furthermore, (PSC) is collaborating with the FDA closely. What is more, their objective is to assure predictable manufacturing, quality tested treatment as well as clinical trial and manufacturing monitoring for safety and efficacy.
Finally, (PSC) received more than 70 issued patents in the field of regenerative medicine.