Abstract
Osteoarthritis (OA) is a chronic degenerative condition of the articular cartilage, which is the most common cause of disability in patients over age 65. Treatment options are limited towards alleviating symptomology.
Mesenchymal stem cells (MSC) are effective at treating osteoarthritis (OA) in animal models and clinical trials [1-6]. Mechanisms of therapeutic activity appear to be associated with regenerative and anti-inflammatory factors produced by MSC [7, 8]. On the one hand, MSC produce soluble factors that are antioxidant [9], antifibrotic [10], and stimulate endogenous chondrogenic progenitors [11], on the other hand MSC directly can differentiate into cartilage tissue [12].
The proposed study will involve intra-articular injection of umbilical cord tissue mesenchymal stem cells (UC-MSC) into joints of 20 patients with grade 2-4 radiographic OA severity and intravenously in 20 patients with grade 2-4 radiographic OA severity. The primary endpoint will be safety and feasibility as assessed by lack of treatment associated adverse events. The secondary endpoint will be improvements in joint function as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Patients will be examined at baseline and 3 and 12 months after treatment.
This, study will provide support for double-blind placebo controlled investigations. The potential of using UC-MSC for this debilitating condition will open the door for future investigations in other inflammatory conditions if results demonstrate safety and feasibility of this approach.
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