Alkem Laboratories recently announced that its off-the-shelf cell therapy product, StemOne has received regulatory approval from the Drug Controller General of India (DCGI) for its launch in India. The product, launched by Alkem Laboratories in collaboration with Stempeutics, is indicated for the treatment of Knee Osteoarthritis, a degenerative disease of the joint. The company claims that It is the first allogeneic cell therapy product to be approved for commercial use in India for the disease.
“The product has been developed by Stempeutics, a group company of Manipal Education and Medical Group, 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. 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, the company claimed.
Knee Osteoarthritis is one of the most common debilitating diseases experienced within an ageing population and constitutes an urgent medical need. According to experts, as the prevalence of obesity, a major risk factor, is increasing, it has led to an increased occurrence of osteoarthritis.
The estimated OA population in India alone is approximately 35 million. Presently, treatment options available include NSAIDs, glucosamine and chondroitin sulphate, Diacerin (IL-1 inhibitor), Hyaluronic Acid injections, steroid injections, PRP injections, and, ultimately, total knee replacement.
The company claims that the existing treatment options focus on providing temporary pain relief and reducing inflammation during the early stages of the disease without affecting the course of the disease.
“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 and Grade 3 Osteoarthritis patients. StemOne has anti-inflammatory and 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,” the company stated.
“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 are able to introduce this stem cell therapy in the country at an affordable cost. Current Knee OA treatments are more symptomatic in nature 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,” Sunil Pathak – Senior Vice President & Cluster Head at Alkem said in a statement.