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A single-center, open-labeled, randomized, 6-month, parallel-group study to assess the safety and efficacy of allogeneic cultured keratinocyte sheet transplantation for deep second-degree burn wounds: rationale and design of phase I/II clinical trial

Crossref DOI link: https://doi.org/10.1186/s13063-024-08070-4

Published Online: 2024-04-01

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Farzanbakhsh, Shayan

Shahrbaf, Mohammad Amin

Madani, Hoda

Dahmardei, Mostafa

Sadri, Bahareh

Vosough, Massoud https://orcid.org/0000-0001-5924-4366
Funding

Funding for this research was provided by:

Royan Institute for Stem Cell Biology and Technology (RI.400000193)
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Article History

Received: 26 August 2023

Accepted: 20 March 2024

First Online: 1 April 2024

Declarations

:

: This study was approved by the Ethics Committee of Royan Institute (IR.ACER.ROYAN.REC. 1400.165) and registered in the Iranian Registry of Clinical Trials (IRCT, ) with identifiers IRCT20080728001031N31 and IRCT20080728001031N36 for phase I and II, respectively. All procedures will be conducted in accordance with the relevant approved regulations, guidelines, and the Declaration of Helsinki.

: N/a. Any personal data such as face images requiring consent will not be published in these studies. However, the informed consent form was uploaded.

: The authors declare that they have no competing interests.

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