India gives nod to cell therapy for Critical Limb Ischemia (CLI)

Stempeucel®, a cell therapy for the treatment of Critical Limb Ischemia (CLI), has been approved for commercial use in India by the Drug Controller General.

cell therapy cells in red on a blue background

Stempeutics Research Pvt. Ltd has received 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.

Stempeutics has been developing the product for twelve years. The company’s proprietary pooling approach provides an efficient manufacturing process, enabling the product to be made accessible to patients at an affordable cost. According to the company, more than one million doses can be produced from a single set of master cell banks, thus providing consistent product to patients. The proprietary technology also helps extend the therapeutic potential of the drug across multiple disease categories, it said. Under an agreement signed between Cipla Limited and Stempeutics, the former has received exclusive rights to market and distribute the cell therapy in India by leveraging its expansive distribution strengths across the country.

CLI is a progressive form of peripheral arterial disease that is caused by severe blockage in the arteries which reduces blood flow and can result in the development of sores and wounds in the legs and feet with a high risk of limb amputation. It is estimated that about five million patients in India are impacted by this debilitating disease; however, it is estimated that only 25 percent of CLI patients can be managed with satisfactory clinical outcomes using the contemporary vascular techniques.

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 and is designed to directly address the root cause of the disease by reducing inflammation, stimulating growth of collateral blood vessels and repairing damaged muscle. The treatment therefore reduces the pain and improves healing of the ulcers, enabling the affected limb to be salvaged. The drug is administered through intramuscular injections around the calf muscle region and around the site of ulcers.

Stempeutics reports it is currently working on a strategy for other international markets including the US, EU and Japan. The global critical limb ischemia treatment market is expected to generate $5,390 million by 2025, at a CAGR (compound annual growth rate) of 8.1 percent between 2020 and 2025.

Dr Pawan Kumar Gupta, Senior Vice President, 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.”