Osteoarthritis of the Knee Clinical Trial
Official title:
Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis
Allogeneic human umbilical cord tissue-derived stem cells injected intravenously (IV) once per day for 3 days or once intra-articularly are a safe and will induce a therapeutic effect in osteoarthritis (OA) patients.
The proposed study will assess primarily safety and secondary efficacy endpoints of
allogeneic umbilical cord mesenchymal stem cells (UC-MSC) administered to 40 patients with
OA. Arm 1 will receive one intra-articular injection of UC-MSC into the knee and Arm 2 will
receive IV UC-MSC once per day for 3 consecutive days.
The primary objective of the trial is freedom from treatment associated adverse events at 3
and 12 months post treatment. Secondary objective will be efficacy as assessed at baseline,
and 3 and 12 months post treatment and will be quantified based on the Western Ontario and
McMaster osteoarthritis index (WOMAC).
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