Personalized Stem Cells Inc gets new drug application clearance to use stem cells for knee OA
Personalized Stem Cells Inc. announced it has received FDA approval for an investigational new drug application for the use of adipose-derived stem cells for the treatment of osteoarthritis.
According to a company press release, the first clinical trial is to begin in August in which stem cells will be used to treat knee OA. Personalized Stem Cells said it wants to perform a series of FDA-approved clinical trials on the treatment with uses in orthopedics and then expand to other medical conditions. The company and FDA will work together to offer alternatives to unregulated, in-clinic stem cell processing and unapproved “regenerative” therapies.
“This first clinical trial will not only provide an approved method for treatment of knee arthritis, but it will also demonstrate that it is possible to work within the FDA regulatory guidelines to bring advanced stem cell therapy to the public,” Michael Dale, co-founder of Personalized Stem Cells, said in the release. “We have made remarkable progress in obtaining our first approval in less than 1 year after forming the company.”