surajpatel
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India,
2021-06-02 09:30
(1851 d 19:56 ago)

Posting: # 22387
Views: 3,673
 

 Registration with CTRI [Regulatives / Guidelines]

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Hi all,

We are planning to conduct a clinical trial with human embryonic stem cells (hESCs) for macular degeneration in Indian population. Will Institutional Review Board approval and CTRI registration alone will be suffice to initiate the clinical trial.

Suraj
 
drgunasakaran1
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2021-06-02 13:39
(1851 d 15:47 ago)

@ surajpatel
Posting: # 22388
Views: 2,936
 

 Registration with CTRI

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Dear Mr Suraj,

❝ Will Institutional Review Board approval and CTRI registration alone will be suffice to initiate the clinical trial.


Stem cell proposals should be reviewed and approved by the institutional committee for stem cell research (IC-SCR) before being submitted to the EC for consideration, in accordance with the National Guidelines for Stem Cell Research (2017).

Since Human Embryonic Stem Cells falls under the Category of Restricted Research, approval from National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) also required along with DCGI approval & CTRI Registration before initiation of clinical trials.
—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
 
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