Regenerative medicine is a branch of translational research in tissue engineering and molecular biology which deals with the “process of replacing, engineering or regenerating human cells, tissues or organs to restore or establish normal function”. Stem cell therapy is the emerging field in the regenerative medicine and holds the promise of engineering damaged tissues and organs by stimulating the body’s own repair mechanisms to functionally heal previously irreparable tissues or organs. Stem cells have potential to heal or replace tissues or organs damaged by age, disease or trauma, as well as to normalize congenital defects. Promising preclinical and clinical data have emerged to support the possibility for treating chronic diseases and to abet maladies occurring across a wide array of organ systems and contexts, including cardiovascular disease, dermal wounds and traumas, treatment of certain types of cancer and more. The current therapy of transplantation suffers from limited donor supply and often severe immune complications, but these obstacles maybe potentially bypassed using regenerative medicine strategies.
Scientists are exploring Regenerative medicines for a wide range of diseases
Recent Developments in the market
In recent years many stem cell products have been approved to treat various disease types. In 2016, Stempeucel became the India’s first and world’s 5th off-the-shelf approved stem cell product. Drugs Controller General (India) has granted Bengaluru based Stempeutics Research (Joint venture of Manipal Education and Medical Group and Cipla Limited) approval for manufacturing and marketing of its stem cell based biological product for the treatment of Buerger’s disease. It is a rare form of a disease affecting the blood vessels of the legs, characterized by inflammation and occlusion of the vessels of extremities that will result in the reduced blood flow to the affected areas leading to severe pain and ulcers or necrosis, which finally may require amputation. European commission granted approval of Takeda’s Alofisel, formerly known as Cx601 in March 2018 for the treatment of complex perianal fistulas in adult patients with crohn’s disease. This is the first allogenic stem cell therapy to receive central marketing authorization (MA) approval in Europe. In April 2018, stem cell therapy developed by the biotech company Nature cell and Biostar Stem Cell Research Institute has been formally approved in Japan to treat milt-to-moderate Alzheimer’s disease patients. Currently there is no drug available to cure this disease. This is first time ever that the stem cell therapy for Alzheimer’s has been given regulatory approval. Still there is a debate over the safety and efficacy of stem cells in treating disease. FDA has approved various products in regenerative medicine such as Carticel, that uses autologous chondrocytes for the treatment of focal articular cartilage defects but till now has not approved any stem cell products. With more research and new data emerging in this field, use of stem cells therapy in regenerative medicine may become a common practice to treat various diseases in the coming decades.
Healthcare Market Research Analyst