Osteoarthritis Clinical Trial
Official title:
Safety and Feasibility Study of Autologous Stromal Vascular Fraction (SVF) Cells for Treatment of Osteoarthritis
Autologous stromal vascular fraction (SVF) injected into joints of 20 patients with grade 2, 3, or 4 radiographic OA severity will be safe and feasible as assessed by lack of treatment associated adverse events. Improvements in joint function as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) are anticipated.
The proposed study is a single center, unblinded, non randomized, phase I/II trial in which
the patients will be treated with a single dose of autologous stromal vascular cells (SVF)
isolated from 500 ml of adipose tissue extracted from the infraumbilical area. The cellular
product will be administered via intra-articular injection into patients with moderate to
severe osteoarthritis (OA). Administration will be performed by injection into the synovial
space. The dosing regimen will consist of two intraarticular injection of autologous SVF into
the index knee. Total injection volume will be about 30 mL in two 15 mL aliquots via a 23
gauge needle inserted 1.5 cm. deep into the intraauricular space of the knee. The total
number of SVF to be injected is 1.0 x 10(7) to 5 x 10(7).
The purpose of this study will be to define the safety and efficacy of SVF therapy in
improving joint function and the quality of life in patients with OA of the knee. We plan to
enroll twenty subjects for treatment for an adequate sample size for safety analysis with
signals of efficacy. The primary safety outcome will be tabulation of adverse events related
to treatment. Efficacy will be quantified at 3, 6 and 12 months by the total Western Ontario
and McMaster Universities Osteoarthritis Index (WOMAC).
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