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Stempeutics conducts research on efficacy and safety of Stempucel in osteoarthiritis

The results of the randomised, double-blind, controlled study in 146 patients showed that Stempeutics’s product Stempeucel-OA significantly improved WOMAC total score compared with the placebo group at six and 12 months

Stempeutics, a leader in allogeneic cellular medicines for inflammatory diseases, announced the publication of the Knee OA Phase 3 trial results in the premier peer-reviewed journal, the American Journal of Sports Medicine (AJSM). The results of the randomised, double-blind, controlled study in 146 patients showed that Stempeutics’s product Stempeucel-OA (bone marrow-derived mesenchymal stromal cells) significantly improved WOMAC total score compared with the placebo group at six and 12 months, and also significantly improved WOMAC pain, stiffness, and physical function sub-scores as well as VAS scores at six 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.

Professor Dr Vivek Pandey, Kasturba Medical College, Manipal, India, who was part of Phase 3 clinical trial, said, “We are encouraged by the early study data at one year follow up (published in AJSM) 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. Currently, there are no approved disease-modifying treatments available. 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. Furthermore, the two-year follow-up clinical and radiological data analysis is very encouraging and will be published soon.”

The Phase-3 study enrolled 146 patients across 15 hospital sites in India, and the results showed that a single intra-articular injection of 25 million cells of Stempeucel-OA along with HA is:

· Safe & efficacious in Grade II & III OA at 1-year follow-up.

· Significant improvement in overall WOMAC composite index (p<0.0001) with 46.6 per cent reduction compared to placebo

WOMAC sub-score:

· Improvement in pain (p<0.0001) with 46.3 per cent reduction compared to placebo

· Improvement in stiffness (p<0.0001) with 55.1 per cent reduction compared to placebo

· Improvement in physical function (p<0.0001) with 45.6 per cent reduction compared to placebo

· Improvement in VAS score (p<0.0001) with 41.6 per cent reduction compared to placebo

· Cartilage quality is maintained as evidenced by T2 mapping done by MRI

· Improvement in pro-inflammatory marker hs-CRP, anti-inflammatory marker IL-10 & CTX II (urine) in the Stempeucel-OA Product arm

“These provocative results may usher in new directions for the field of cell-based regenerative therapies in the coming decade,” stated Dr Nikhil N Verma, MD (Rush University Medical Center, Chicago, Illinois, USA), 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 Bone Marrow MSCs 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. Our Phase III trial is a double-blind, randomised, placebo-controlled trial. 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. Stempeucel-OA offers a novel treatment approach to the physicians in India to treat Knee OA and will substantially improve the quality of life of millions of patients suffering from this painful disease.”

 

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