Alkem, in partnership with Stempeutics, launches stem cell therapy to treat knee osteoarthritis

Alkem Laboratories, in collaboration with Stempeutics, has launched the first ‘made-in India’ off-the-shelf cell therapy product “StemOne” to treat Knee Osteoarthritis (OA). The company announced that it has received a regulatory approval from the Drugs Controller General of India (DCGI) for the product. It is the first allogeneic cell therapy product to be approved for commercial use in India for Knee OA, the companies said in a joint statement.

The product has been developed for over a period of twelve years. The company’s proprietary technology platform provides for an efficient manufacturing process, thereby, enabling the product to be made accessible to patients at an affordable cost.

Commenting on the DCGI approval, Manohar BN, MD and CEO, Stempeutics, said, “Obtaining DCGI approval for StemOne is an important and historic milestone for Stempeutics. It is a strong recognition for Stempeutics for its sustained excellence of scientific and clinical work and underscores our global leadership in allogeneic, pooled MSC technology…….”

Dr Pawan Gupta, Sr Vice President, Medical and Regulatory Affairs, Stempeutics, also said in the statement, “StemOne product is developed from bone-marrow derived, cultured-pooled, allogeneic mesenchymal stromal cells. Our phase-III trial is a double-blind, randomised, placebo-controlled trial. We have administered StemOne using ultrasound guidance and used new MRI techniques called T2 mapping to assess the quality of articular cartilage…….”