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AUG 30, 2016 8:00 AM PDT

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

Speaker
  • CSO & Executive VP, Stempeutics Research, India
    Biography
      Dr. Anish S Majumdar is the Chief Scientific Officer & Executive VP of Stempeutics Research in Bangalore, India, since 2010. He has been working in the field of stem-cell based research and product development for more than 20 years. Dr. Majumdar received his Ph.D. in Biochemistry/Immunology from the University of Calcutta, India. He pursued postdoctoral research at the University of Pennsylvania and subsequently joined Stanford University as a Research Scientist. He has worked at Indian and US based biopharmaceutical/cell therapy companies in various positions: Among the US companies are BD Biosciences, Aventis, and Geron Corporation. Dr. Majumdar joined Geron Corporation in 1998 and became Senior Director, Cell Therapy Research in 2005. In 2007, he relocated to India where he joined Reliance Life Sciences, Mumbai as Vice President of Stem Cell Research & Regenerative Medicine. He has published nearly 80 research articles, reviews, and book chapters in acclaimed journals and is a co-inventor of 70+ international patents. Dr. Majumdar's research expertise spans from the biology, immunology and therapeutic applications of mesenchymal stem cells (MSC), differentiation of human embryonic stem cells (ESC), dendritic cells, and T-cells for developing anti-cancer vaccines. Currently, the use of MSCs for various therapeutic applications in regenerative medicine is his focus at Stempeutics, and has met with strong success.
      He is a member of the Industry Committee of the ISSCR, Federation of Indian Chamber of Commerce, and Industry (FICCI) for the Biotechnology Chapter as a stem cell expert. In 2013, Dr. Majumdar was elected as Vice President for Asia region of the ISCT. In this position, he represents India and Asia, and he is committed to promoting the use of stem cell based therapeutics for diseases with unmet or urgent medical need.

    Abstract
    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.
     

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