An open label, multicenter Post Marketing Surveillance Study in India to assess safety and efficacy of Intramuscular administration of stempeucel® in patients with critical limb ischemia due to Buerger’s disease

Buerger’s disease (Thromboangiitis obliterans (TAO)) is a serious medical condition with an unmet medical need. The disease is characterized by segmental occlusive inflammatory condition of arteries and veins, and thrombosis and recanalization of the affected vessels. Buerger’s disease usually occurs in people around the age of 40 - 45 years and is more frequent in male smokers. Critical limb ischaemia (CLI) due to Buerger’s disease is a manifestation of peripheral arterial disease (PAD) that describes patients with chronic ischaemic rest pain, or patients with ischaemic skin lesions, either ulcers or gangrene. Stempeucel® is a formulation of Adult human bone marrow derived, cultured, pooled allogeneic Mesenchymal Stromal Cells (MSCs) intended for intramuscular injection (IM) only. Stempeucel® is indicated in Buerger’s disease patients with established critical limb ischemia in Rutherford III-5 or III-6 (gangrene limited to the toes), not eligible for or have failed traditional revascularization treatment, with rest pain and / or ulcers in the affected limb. This post marketing surveillance study will include 200 patients administered with stempeucel® in 10 selected centres. These patients will be followed up for a duration of 12 months from the time of administration of stempeucel®. This PMS study is being conducted post marketing approval of the product Stempeucel® for CLI due to Buerger’s disease as per the regulatory requirement.