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Article History

Received: 24 August 2022

Accepted: 17 March 2023

First Online: 1 April 2023

Declarations

:

: This study was approved by the Subject Expert Committee of Indian FDA and institutional ethics committees of all participating sites. Details of the same are given below, Title of the approved project: A label extension, single-arm, multi-centric, phase III study to assess efficacy and safety of stempeucel® (Adult human bone marrow derived, cultured, pooled, allogenic mesenchymal stromal cells) in patients with critical limb ischemia due to atherosclerotic peripheral arterial disease. Hospital Name: Vijaya Hospital, Chennai; Name of the Ethics Committee: Institutional Ethics Committee of Vijaya Institute of Clinical and Medical Research; Approval No.: EC/LTR/2018/018; Approval date: 25 May 2018. Hospital Name: M S Ramaiah Hospital, Bangalore; Name of the Ethics Committee: Ethics Committee M S Ramaiah Medical College and Hospital; Approval No.: NA; Approval date: 22 May 2018. Hospital Name: Krishna Institute of Medical Sciences (KIMS), Hyderabad; Name of the Ethics Committee: KIMS Ethics Committee, KIMS Hospitals; Approval No.: KIMS/EC/2018/22-1. Approval date: 27 Jun 2018. Hospital Name: GSVM Medical College, Kanpur; Name of the Ethics Committee: Ethics Committee GSVM Medical College Kanpur; Approval No.: 68/EC notification (Meeting/Approval/Au/2018); Approval date: 11 Sep 2018. Hospital Name: Health Point Hospital, Kolkata; Name of the Ethics Committee: Health Point Ethics Committee; Approval No.: HP/EC/17-18/023; Approval date: 16 Nov 2018. Hospital Name: Sri Jayadeva Institute of Cardiology, Bangalore; Name of the Ethics Committee: Sri Jayadeva Institute Ethics Committee; Approval No.: NA; Approval date: 28 Dec 2018. Hospital Name: All India Institute of Medical Sciences (AIIMS), New Delhi; Name of the Ethics Committee: Institutional Ethics Committee AIIMS, New Delhi; Approval No.: IEC-221/05.04.2019, RP-01/2019; Approval date: 11 Jun 2019.

: Written informed consent for publication was obtained from the participants of study.

: The authors Pawan Kumar Gupta, Shivshankar P, Raviraja N S, Samatha Bhat, Pachaiyappan Vishwanathan, Suresh Kannan, Jijy Abraham, Hema Boggarapu, Manjuprasad M S and Udaykumar K are permanent employees of Stempeutics Research Pvt. Ltd., where the commercial study drug stempeucel® is being manufactured. The remaining authors have no competing interest to declare.