Is stem cells therapy for Osteoarthritis approved in India ?
The bone and joint disorders; is the current theme of world health problems; as it has been estimated that osteoarthritis (OA) is the fourth leading cause of disability worldwide. These numbers of global incidences and proportional rise in orthopedic surgeries have inflamed the demand for alternative technology. In this regard, regenerative medicine is materializing, as the technologically innovative branch of medical science that is being extensively supporting the global use of stem cells therapy for treating bone and joint disorders. Nonetheless, regulatory constraints are posing major threats to the development and clinical acceptance of stem cells therapy for osteoarthritis; which have to be rectified in breaking out stereotypes.
What is Osteoarthritis
Osteoarthritis is a chronic but lazy disease that is affecting all genders, age and races; but is known to be commonly affecting elderly and obese people. It is an indication of cartilage degeneration between weight bearing joints. It’s pathogenesis is associated with, inability of cartilages to withstand biochemical, mechanical stresses, lack of nutrients as well as oxygen supply, and inability to synthesize extracellular matrix; leading to overall degeneration of cartilage. Thus, lack of this cushioning material in between the joints; may lead to heightened friction between the two bones, resulting in joint pain, stiffness and tenderness.
Stem Cell Management
Quite reasonably, body has a power of self regeneration, through which cartilages can be regenerated along with chondrocytes, matrix and elastin fibers. However, the process is very slow, giving rise to highly fragile tissue that cannot tolerate intensive body weight.
In this regard, the aim of using stem cells from the autologous sources of patient’s own body is to speed up the self-healing process that may result in relieving OA symptoms. Although, it has well been standardized that in order to improve functional status and quality of life; stem cells should be applied in conjunction with other simulative therapies, to promote faster and stronger regeneration of cartilages.
Regulating stem cells therapy in India
According to the recent declaration of revised guidelines of stem cells therapy, by Indian Council of Medical Research & Department of Biotechnology; autologous applications of stem cells to treat various immunological, hematological and metabolic disorders can be exempted; as these practices are in vogue in India, since last three to four decades. Additionally, stem cells treatment for some of the disorders such as osteoarthritis and eye disorders, have been specifically emphasized by experts all over India as an established method of care; may be because no other alternatively safe method is currently available to treat such cases.
For the last few years, more than 1000-1500 patients have been treated for their OA, with the help of stem cells; expressing sufficient evidences and feasibility to confirm its safety. Besides, through the clinical trial perspectives, clinical studies for evaluating safety, efficacy and feasibility of stem cells application in problems such as osteoarthritis is already gone through R&D, Preclinical, Phase I To III clinical trials and is nearing completion of its final phase; waiting for the amendment to be noted in Drug and Cosmetic Act to approve and regularize it in India.
Thus, these reasons are compelling enough, for regulatory authorities of India; to apply the same yardstick in case of stem cells therapy approval for osteoarthritis and correct the oddity.