02226-A: Pilot Clinical Trial to Test the Efficacy of Mesenchymal Stem Cells Over-Expressing IL-10 to Treat Osteoarthritis in Elbows of Senior Dogs
Grant Status: Closed
Abstract
Osteoarthritis (OA) is characterized by both chronic inflammation and structural defects in cartilage and subchondral bone. Mesenchymal stem cells (MSC) have become ideal candidates for therapeutic intervention because these cells could contribute to the treatment of OA in two ways: they can differentiate and replace the damaged cartilage and bone, but also secrete key signals that regulate the immune system. In fact, at least 13 early-stage human clinical trials are underway and three canine trials have been completed testing the delivery of MSCs into patients with OA. Certainly, this approach has, and is expected to demonstrate, a satisfactory safety profile. However, to date, clinical efficacy has been poor, due to an insufficient contribution from the cells. Dr. Fierro and team propose an optimized treatment for OA by combining cell and gene therapies which will induce the expression of the anti-inflammatory cytokine interleukin 10 (IL-10) in canine adipose tissue derived-MSCs. This approach is based on the research team's experience on a planned first-in-human Phase I clinical trial with a very similar approach, strictly adhering to the same safety profile requested by both clinicians and regulatory agencies. The main goal of this proposal is to conduct a pilot study in four senior dogs, injecting 5-7 million MSC/IL-10 cells (carried in 0.5 ml hyaluronic acid) into one elbow with more severe OA. The proposed outcome measurements are objective and rely on the latest technology. With this pilot study, the investigators expect to demonstrate both safety and efficacy of MSC therapy for this important unmet clinical need, and ultimately find a cure for OA in senior dogs.
Publication(s)
None at this time.
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