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Authors
Madhuri, Vrisha https://orcid.org/0000-0003-4494-222X
Ramesh, Sowmya
Sahoo, Bibhudutta
Sivadasan, Suresh Babu
Rajagopal, Karthikeyan
Kandagaddala, Madhavi
Fernandez, Francis. B.
Gibikote, Sridhar
Balasubramanian, Balakumar
Chilbule, Sanjay K.
Dinesh, Vivek Dutt
Thambaiah, Augustine
Tabasum, Aleya
Srivastava, Alok
Mathews, Vikram
John, Annie
Varma, Harikrishna
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Funding
Funding for this research was provided by:
Department of Biotechnology, Ministry of Science and Technology, India (BT/PR5424/MED/31/162/2012)
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Article History
Received: 30 July 2024
Revised: 24 February 2025
Accepted: 12 March 2025
First Online: 21 March 2025
Declarations
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: This pilot study was approved by the institutional review board, Christian Medical College, Vellore, India; IRB Min No. 7021, Institutional Committee for Stem Cell Research and Therapy (IC-SCRT) and registered in the national clinical trial registry (CTRI/2014/09/005027). The necessary approval from the Human Ethics Committee of the National Medical Research Council was obtained. The Drug Controller General of the country permitted the manufacture and use of the scaffold and cell-scaffold product in a clinical trial setting. The funding agency constituted a DSMB prior to the initiation of the trial. The trial was conducted according to the declaration of Helsinki and was consistent with good clinical practice and the applicable national laws and regulations.
: We have obtained consent trial from the child’s parent or legal guardian to participate in the clinical trial.
: We have obtained consent to publish data/photograph arising from this clinical trial from the child’s parent or legal guardian.
: The authors declare no competing interests.
