Alkem Labs, Stempeutics get DCGI nod for knee osteoarthritis treatment

New Delhi: Mumbai-based Alkem Laboratories has 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 (OA). 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, to maintain cartilage quality and to stall further disease progression in Grade 2 & Grade 3 Osteoarthritis patients. It 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.