First Allogeneic Mesenchymal Stromal Cell Product Approved in India for Buerger's Disease - An Unmet Medical Need

Buerger’s disease, commonly known as Thromboangiitis obliterans, is a non-atherosclerotic, segmental inflammatory disease that can affect the small and medium-sized arteries of young people with a history of heavy tobacco use. Its prevalence among all patients with peripheral arterial disease varies widely in different regions of the world.

Critical limb ischemia (CLI) is a severe form of the disease that results in acute rest pain and non-healing ischemic skin ulcers and gangrene of the lower extremity which can results in limb amputation if left untreated. Bone marrow derived MSC (BMMSC) are known to possess strong immunomodulatotory properties, promote angiogenesis and tissue regeneration through paracrine activity. Using a patented pooling technology of BMMSC from different healthy donors, we have developed an allogeneic BMMSC product, Stempeucel. Stempeucel is manufactured in a GMP facility and cryopreserved as an off-the-shelf product [1]. A series of preclinical studies were conducted to establish the safety [2] and efficacy profiles of the pooled BMMSC population. More importantly, results obtained from our phase I/II clinical trial in CLI patients demonstrated the safety of Stempeucel in humans [3]. A large phase II was recently completed with two different doses of Stempeucel. The cells were injected intramuscularly at multiple locations around the calf muscle and also around the ulcer. Analysis of the data six months after Stempeucel administration revealed statistically significant improvements in patients for both the primary clinical end points i.e., relief of rest pain and ulcer healing in the  target limb as  compared to the control group of patients [4]. In addition, ankle brachial pressure index (ABPI) also showed significant improvement in the same cell dose group, suggesting improved blood flow in the limb. As such, Stempeucel has been approved by the regulatory authorities in India for its use in a limited number of “No Option” Buerger’s disease patients.