Biologics company gets FDA approval to study adipose-derived stem cell treatment — 4 insights

Biologics

The FDA approved Personalized Stem Cells' new drug application for its adipose-derived stem cell-based osteoarthritis treatment.

What you should know:

1. The company will launch a clinical trial this August.

2. This is the first of several clinical trials. PSC is attempting to earn FDA approval for its stem cell-based osteoarthritis treatment.

3. PSC is focusing on orthopedic treatments to begin with before expanding to other conditions in the future.

4. PSC and the FDA are working together to provide a monitored alternative to the unapproved regenerative therapies on the market.

"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," said PSC co-founder Michael Dale.

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