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BENGALURU, India

Stempeutics, a leader in allogeneic cellular medicines for inflammatory diseases, announced the publication of the Knee OA Phase 3 trial results in the premier journal, the American Journal of Sports Medicine (AJSM). The results of the randomized, double-blind, controlled study in 146 patients showed that single injection of Stempeucel-OA (bone marrow-derived mesenchymal stromal cells) significantly improved WOMAC total score compared with the placebo group at 6 and 12 months, and also significantly improved WOMAC pain, stiffness, and physical function sub-scores as well as VAS scores at 6 and 12 months. MRI T2 mapping showed no worsening of deep cartilage in the medial femorotibial compartment of the knee in the Stempeucel-OA group at the 12-month follow-up, whereas in the placebo group, there was significant and gradual worsening of cartilage.

Details of the Phase 3 study can be accessed in the paper published: https://journals.sagepub.com/doi/abs/10.1177/03635465231180323

Professor Dr Vivek Pandey, MS (Kasturba Medical College, Manipal, India), who was part of Phase 3 clinical trial, said, “We are encouraged by the study data at one year follow up that indicate the potential of allogeneic cellular therapy to address the major areas of unmet need in Knee Osteoarthritis in young patients where conventional treatments provide only temporary pain relief and do not alter the disease course. Stempeucel®-OA, based on the Phase 3 trial data at one-year follow-up, has the potential to provide best-in-class pain reduction, improve stiffness, improves physical function, improve quality of life, and has the potential to regenerate/maintain cartilage and stall further disease progression for Grade 2 & Grade 3 Osteoarthritis patients based on the Kellgren and Lawrence radiographic criteria.”

“These provocative results may usher in new directions for the field of cell-based regenerative therapies in the coming decade,” stated Dr Nikhil Verma, MD (Rush University Medical Center, Chicago, Illinois), who made a poster presentation at American Orthopaedic Society of Sports Medicine Conference at Colorado Springs, US in 2022. Stempeutics has analysed the potency of Stempeucel-OA by their ability to secrete pro-chondrogenic factors such as TSP-2. As osteoarthritis is a degenerative disease associated with the loss of cartilage, we believe that the presence of these molecules in the secretome of MSCs affects the clinical outcome. TSP-2 is an extracellular matrix protein that plays a major role in determining the chondrogenic differentiation potential of MSCs and stimulates the differentiation of endogenous chondroprogenitor cells.

Dr Pawan Gupta, President, Medical & Regulatory Affairs, Stempeutics, said, “The Stempeucel-OA product is developed from Stempeucel® Technology, i.e. Bone Marrow-Derived, Cultured Pooled, Allogeneic Mesenchymal Stromal Cells. We have administered Stempeucel-OA using ultrasound guidance and used T2 mapping MRI techniques to assess the quality of articular cartilage. We are delighted to see statistically significant data on our primary endpoint, i.e., the change from baseline to one year in the WOMAC Osteoarthritis Composite Index score compared to the placebo arm.”

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