The treatment comprises a single intra-articular injection of StemOne in an outpatient procedure with no anaesthesia requirement
Alkem Laboratories announced that regulatory approval has been received from the Drug Controller General of India (DCGI) for the launch of StemOne in India. The product is indicated for the treatment of knee osteoarthritis. It is the first allogeneic cell therapy product to be approved for commercial use in India for Knee OA.
The product has been developed by Stempeutics, a group company of Manipal Education and Medical Group, for over 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. More than one million doses can be produced from a single set of master cell banks, which is unique in regenerative medicine, thus providing consistent products to patients.
StemOne has the potential to provide best-in-class pain reduction, improve quality of life, has the potential to maintain cartilage quality and to stall further disease progression in Grade 2 & Grade 3 Osteoarthritis patients. StemOne has anti-inflammatory & immunosuppressive properties which reduce inflammation in the knee joint. StemOne may initiate the repair process by differentiating into chondrocytes or by inducing proliferation and differentiation of endogenous chondro-progenitors into mature chondrocytes or both.
Sunil Pathak – Senior Vice President & Cluster Head at Alkem said, “Our focus on innovation is guided by our strong sense of responsibility to address unmet patient needs and alleviate suffering. Knee OA is a serious and painful condition that impacts patients worldwide and we are happy that we can introduce this stem cell therapy in the country at an affordable cost. Current Knee OA treatments are more symptomatic whereas StemOne drug has the potential to address the root cause of the disease. StemOne 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”.
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. We believe that the StemOne product is a game-changer, offering advanced treatment for millions of patients suffering from this painful disease.”
Dr Pawan Gupta, Sr Vice President, Medical & Regulatory Affairs, Stempeutics said, “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. We are happy to see statistically significant data on our primary endpoint i.e., the change from baseline to one year in WOMAC (Western Ontario and McMaster Universities Osteoarthritis) Osteoarthritis Composite Index score as compared to the placebo arm. Also, statistical significance was observed in WOMAC OA Pain Index/ Stiffness Index / Physical function Index.”
