NCT02357485

ADSC Injections for Pain Management of Osteoarthritis in the Human Knee Joint

Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Fodor, Peter B, M.D. · Individual
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This safety and feasibility study used autologous adipose-derived stromal cells (ADSC), the stromal vascular fraction (SVF), to treat 8 osteoarthritic (OA) knees in 6 patients of grade I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under Institutional Review Board (IRB) approved protocol.

Detailed description

This safety and feasibility study used autologous adipose-derived stromal cells, the stromal vascular fraction, to treat 8 osteoarthritic knees in 6 patients of grade I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under IRB-approved protocol. Evaluation of the safety of intra-articular injection of the stromal vascular fraction cells was the primary objective of the study. Adipose-derived stromal vascular cells were obtained through enzymatic disaggregation of lipoaspirate, resuspended in 3 ml of Lactated Ringer's Solution, and injected directly into the intra-articular space with a mean of 12 million viable nucleated SVF cells per knee.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
BIOLOGICAL	ADSC	Single injection of ADSC

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2015-02-06
• Last updated: 2015-06-30
• Results posted: 2015-03-27