Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis

Summary

The objective of this clinical study is to evaluate the safety of an intraarticular injection of an investigational biologic product (IBP), PSC-01, the patient's own adipose-derived stromal vascular fraction cells (SVF) extracted from a lipoaspirate sample, to treat the pain of osteoarthritis in a single knee. The secondary objective is to get initial data on efficacy of the PSC-01.

Timeline

Start

2019-09-07

Primary completion

2021-01

Completion

2021-01

Publications

• Rogers CJ, Harman R, Sheinkop MB, Hanson P, Ambach MA, David T, Desai R, Sampson S, Aufierro D, Bowen J, Malanga G. Clinical Evaluation of Safety and Efficacy of a Central Current Good Manufacturing Practices Laboratory Produced Autologous Adipose-Derived Stromal Vascular Fraction Cell Therapy Product for the Treatment of Knee Osteoarthritis. Stem Cells Dev. 2024 Apr;33(7-8):168-176. doi: 10.1089/scd.2024.0008.

Drugs

Indications