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Preprints

Clinical Trials on Stem Cells as a Therapeutic Agent: An Analysis From Clinical Trials Registry-India (CTRI)

Ray S, Chavan C.
Preprint from
Research Square
23 August 2021
PPR
PPR386468
Abstract
The stem cells have abundant potential for innovative therapeutic programs to replace or regenerate cells or tissues having functional impairment. Since the introduction of stem cell therapy using embryonic stem cells in 1998, the clinical use of the stem cells has increased. On the scientific ground, it is necessary to pass the clinical trials, otherwise, it may be recognised as an unproven therapy. The market of unproven stem cell therapy got attention when stem cell clinics started to advertise and claim to cure untreatable diseases. Indian Government has thus considered stem cell as a drug, and stem cells gone under clinical trials for market approval. In this study, we studied research trends related to clinical trials using stem cells as a therapeutic agent based on data obtained from the Clinical Trial Registry of India (CTRI). Our study showed that many clinical trials on the stem cells have been registered in the CTRI database, but only few of the clinical trials has been focusing on the actual stem cell drug development process. The greatest part of these trials were interventional and focused on bone marrow stem cells. On the other hand, only 2% of clinical trials actually focused on iPSCs. There is need to promote randomized clinical trials than single arm trials then our reliability on outcome from clinical trials may increases.