|Ahead of print publication
Current scenario of clinical trials on stem cells as a drug in India: A clinical trials registry of India database analysis
Chandrashekhar Chavan, Suman Ray
CSIR-National Institute for Science Communication and Policy Research, New Delhi; Academy of Scientific and Innovative Research (AcSIR), Ghaziabad, Uttar Pradesh, India
|Date of Submission||08-Jul-2022|
|Date of Acceptance||16-Sep-2022|
|Date of Web Publication||14-Nov-2022|
CSIR-National Institute of Science Communication and Policy Research, Dr. K S Krishnan Marg, Pusa Gate, New Delhi - 110 012
Source of Support: None, Conflict of Interest: None
|How to cite this URL:|
Chavan C, Ray S. Current scenario of clinical trials on stem cells as a drug in India: A clinical trials registry of India database analysis. Perspect Clin Res [Epub ahead of print] [cited 2022 Dec 9]. Available from: http://www.picronline.org/preprintarticle.asp?id=360882
| Introduction|| |
Stem cell therapy shows promising treatment options for many untreatable diseases such as spinal cord injury, heart failure, retinal and macular degeneration, and diabetes type 1. In these diseases, stem cells helped to revert to normal functioning. According to the National Guidelines for Stem Cell Research 2013 and the New Drugs and Clinical Trials Rules 2019, stem cells are considered a drug, not a therapy. Therefore, rigorous clinical trials are required for marketing authorization. On this ground, we tried to show trends and analyses of clinical trials registered at the Clinical Trials Registry of India (CTRI) database. Using this database,, no study has been reported yet on stem cells.
| Methods|| |
In the CTRI database (www.ctri.nic.in), a primary search was conducted on May 31, 2021, using the keyword “stem cell”. We found that 161 clinical trials were registered between the period June 2008 and May 31, 2022. After scrutiny, we considered only interventional 61 clinical trials for further analysis. It is sorted based on interventional, observational, and stem cells used as a therapeutic agent or a drug in the trials. For the analysis, a dataset was prepared using the following components: registration number, study title, registration year, nature of registration, recruitment status, study type phase of the trial, target disease, type of stem cell used, primary sponsor, study duration, and sample size. During this analysis, we use standard definitions provided by “ClinicalTrials.gov.” In addition, we also considered those trials where data are missing or not provided and recorded as separate categories for the analysis.
| Results|| |
The clinical trials were registered as prospectively (49%), retrospectively (39%), and 24% of trials did not mention registration type. Only 39% of trials were registered as randomized clinical trials and 15% as nonrandomized clinical trials. Meanwhile, the trials for single-arm study (44%) got more attention than others. Phase 1 (49%), Phase 2 (24%), Phase 3 (10%), and Phase 4 (1%) were registered, whereas 15% of the studies did not mention the type of Phase. The status of patient recruitment of the clinical trials is as follows: (1) clinical trials were not yet recruited 15%, (2) open for recruitment 21%, (3) closed for recruitment 10%, (4) completed their recruitment 15%, (5) terminated trials 20%, and (6) 19% of trials did not mention any record regarding recruitment status.
In these trials, autologous stem cells (46%) were used more than allogeneic stem cells (49%). The contribution of bone marrow-derived stem cells (70%) is much higher than any other kind of stem cell source. The musculoskeletal disorders (31%) were used as targeted diseases for the clinical trials than other kinds of diseases such as cardiovascular disorders (18%), dental disorders (3%), diabetes and kidney disorders (7%), digestive disorders (7%), eye disorders (5%), hematological disorders (7%), neurological and mental disorders (8%), reproductive system disorders (3%), and respiratory disorders (11%). Moreover, the private bodies (64%) acted as primary sponsors in comparison with public bodies (31%) and individuals acting as primary sponsors (5%).
| Discussion|| |
Among selected 61 interventional clinical trials, single-armed trials (44%) were mostly prioritized instead of randomized clinical trials (39%). More trials were found in the Phase 1 level than in others. This indicates that the conditions for conducting clinical trials may face obstacles at the financial, regulation, ethical, institutional, and research integrity levels. The patient recruitment status for the trials was critical because only 15% of trials completed their recruitment, and the remaining trials were in the process of recruitment. India is far behind in implementing induced pluripotent stem cells technology in the medical field, and only one observational trial was registered (CTRI/2019/11/022000).
We missed some important information about the trials during analyses which are not available (or not recorded) on the CTRI database. A similar data missing problem was also found at ClinicalTrials.gov., For future perspectives, there is a need for a comprehensive policy statement from the government regarding the promotion of stem cells as a drug which ensures support and promotes stem cell research and therapy in India.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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