Osteoarthritis of the Knee Clinical Trial
Official title:
Safety and Feasibility Study of Mesenchymal Trophic Factor (MTF) for Treatment of Osteoarthritis
Allogeneic mesenchymal trophic factors (MTF) from human umbilical cord tissue-derived mesenchymal stem cells (UC-MSC) injected into the knee joints of 20 patients (group 1) or injected subcutaneously into 20 patients (group 2) is a safe and useful procedure for inducing joint function improvements in osteoarthritis (OA) patients with grade 2, 3, or 4 radiographic OA severity.
The proposed study will assess primary safety and secondary efficacy endpoints of allogeneic
UC-MSC-derived MTF administered to two arms osteoarthritis patients with grade 2, 3, or 4
radiographic OA severity (20 per arm). The first arm will receive an intra-articular
injection of MTF into the knee joint under fluoroscopy. The second arm will receive 12
subcutaneous MTF injections, once per week.
For both arms, the primary objective of safety will be defined as freedom from treatment
associated adverse events for the period of one year. The secondary objective of efficacy
will include evaluation at baseline and at months 3 and 12 of efficacy endpoints of joint
function improvement as assessed by Western Ontario and McMaster Universities Osteoarthritis
Index (WOMAC).
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