Stempeutics Research Bangalore is a late stage life science company focused on developing and commercializing novel therapeutics based on adult stem cells. It was founded by the Manipal Group in 2006. Stempeutics strength lies in developing innovative stem cell based products by nurturing cutting edge research and clinical applications through dedicated efforts of its highly qualified team. Scientists working at Stempeutics have filed over 60 patents and have published over 75 peer reviewed international publications.
Company’s flagship product is Stempeucel® drug. It is an on-demand, off-the-shelf product based on pooled, allogeneic Mesenchymal Stromal Cells (MSC) derived from bone marrow of healthy, adult volunteers. Stempeucel® is being developed for the treatment of Critical Limb Ischemia (CLI) amongst other indications such as Osteoarthritis (OA) & Diabetic Foot Ulcer (DFU). In 2017 DCGI (Indian FDA) has granted manufacturing & marketing approval for Stempeucel® for the treatment of CLI patients due to Buerger’s disease. DCGI has also given approval for label extension Phase 3 study for atherosclerotic CLI. Stempeucel product has been licensed to Cipla for CLI indication and to Alkem Labs for OA indication for the India territory. Stempeucel® has strong patent protection with 18 patent applications filed across the globe. These patents create a strong barrier to entry for the development of alternative pooled allogeneic stem cell products by competitors. The core Stempeucel® patent has been granted in USA, Australia, New Zealand, South Africa, Japan, China, Singapore, UK, France, Germany, Italy and Philippines. Stempeucel® has been classified as an ATMP product by EMA and designated as an Orphan Drug for the treatment of CLI due to Buerger’s Disease. Stempeutics’s goal is to globalize Stempeucel® product in US/EU.