Stempeucel, first ‘Made in India’ cell therapy to treat Critical Limb Ischemia

New Delhi: Stempeutics Research has received the regulatory approval by the Drug Controller General of India (DCGI) for the launch of Stempeucel® in India. The product is indicated for the treatment of Critical Limb Ischemia (CLI) due to Buerger’s Disease and Atherosclerotic Peripheral Arterial Disease. It is the first allogeneic cell therapy product to be approved for commercial use in India and the first stem cell product to be approved globally for CLI treatment.

Under an agreement, Cipla has received exclusive rights to market and distribute the product in India by leveraging its expansive distribution strengths across the country.

The product has been developed by Stempeutics over a period of twelve years. The company’s proprietary pooling approach 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 product to patients. The proprietary technology also helps Stempeucel® extend the therapeutic potential of the drug across multiple disease categories.

CLI is a progressive form of peripheral arterial disease that is caused by severe blockage in the arteries thereby reducing blood flow. This may result in the development of sores and wounds in legs and feet with a high risk of limb amputation. It is estimated that about 5 million patients in India are impacted by this debilitating disease. With the current contemporary vascular techniques, it is estimated only 25% of patients can be managed with satisfactory clinical outcomes.

Commenting on the DCGI approval, Mr. Manohar BN, MD & CEO of Stempeutics said, “Obtaining DCGI approval for Stempeucel® 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 Stempeucel® product is a game-changer, offering an advanced therapeutic treatment for millions of patients suffering from this dreadful disease.”

Mr. Umang Vohra, Managing Director and Global CEO of Cipla, said, “Our focus on innovation is guided by our strong sense of responsibility to address unmet patient needs and alleviate suffering. We are pleased to see that our decade-long partnership with Stempeutics has achieved a significant milestone. CLI 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.”

Stempeucel® is a breakthrough treatment which is designed to enhance the body’s limited capability to restore blood flow in ischemic tissue. It is derived from allogeneic pooled mesenchymal stromal cells isolated from the bone marrow of healthy, adult voluntary donors. It directly addresses the root cause of the disease by reducing inflammation, stimulating growth of collateral blood vessels and repairing damaged muscle, thereby reducing the pain, healing the ulcers and salvaging the affected limb. The drug is administered through intramuscular injections around the calf muscle region and around the site of ulcers.

Currently, Stempeutics is working on a strategy for other international markets including US, EU and Japan. The global critical limb ischemia treatment market expected to generate USD 5,390 million by 2025, at a CAGR of 8.1% between 2020 and 2025.

Dr Pawan Kumar Gupta, Senior VP, Medical & Regulatory Affairs, Stempeutics, said, “We are excited to receive this marketing approval from DCGI for this very important indication. In CLI, fatty deposits block arteries in the leg, leading to greatly reduced blood flow, pain at rest, non-healing ulcers, and gangrene. Patients with CLI are at an immediate risk for limb amputation and death. Now Stempeucel® provides hope for a new, effective treatment and a better quality of life for such CLI patients. Also, Stempeutics is committed to advancing its peripheral artery disease programs in CLI to other parts of the World.