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©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Exp Med. Sep 20, 2025; 15(3): 105973
Published online Sep 20, 2025. doi: 10.5493/wjem.v15.i3.105973
Published online Sep 20, 2025. doi: 10.5493/wjem.v15.i3.105973
Comparative outcome analyses of stromal vascular fraction vs nanofat in primary osteoarthritis knee: A double-blinded randomized controlled trial protocol
Naveen Jeyaraman, Sandeep Shrivastava, Arulkumar Nallakumarasamy, Department of Orthopaedics, Datta Meghe Institute of Higher Education and Research, Wardha 442004, Maharashtra, India
Naveen Jeyaraman, Arulkumar Nallakumarasamy, Swaminathan Ramasubramanian, Sathish Muthu, Madhan Jeyaraman, Department of Regenerative Medicine, Agathisha Institute of Stemcell and Regenerative Medicine, Chennai 600030, Tamil Nadu, India
Naveen Jeyaraman, Ravi Velamoor Rangarajan, Arulkumar Nallakumarasamy, Swaminathan Ramasubramanian, Madhan Jeyaraman, Department of Regenerative Medicine, Mother Cell Regenerative Centre, Tiruchirappalli 620017, Tamil Nadu, India
Naveen Jeyaraman, Sathish Muthu, Madhan Jeyaraman, Department of Orthopaedics, Orthopaedic Research Group, Coimbatore 641045, Tamil Nadu, India
Sathish Muthu, Central Research Laboratory, Meenakshi Medical College Hospital and Research Institute, Meenakshi Academy of Higher Education and Research, Kanchipuram 631552, Tamil Nadu, India
Madhan Jeyaraman, Department of Orthopaedics, ACS Medical College and Hospital, Dr MGR Educational and Research Institute, Chennai 600077, Tamil Nadu, India
Author contributions: Jeyaraman N designed the research; Jeyaraman N and Nallakumarasamy A analyzed the articles for performing review and wrote the manuscript; Shrivastava S, Ravi VR, Ramasubramanian S, Muthu S, and Jeyaraman M finalized the manuscript.
Institutional review board statement: IRB No. Plasmaart Resto Ethics Committee PR23NJS016 dated 28.10.2023.
Clinical trial registration statement: CTRI/2024/03/064076 dated 13.03.2024.
Informed consent statement: All authors consented in publishing the protocol.
Conflict-of-interest statement: No conflicts of interests in publishing the protocol.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Data sharing statement: Data is contained within the manuscript.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Madhan Jeyaraman, PhD, Assistant Professor, Postdoctoral Fellow, Department of Orthopaedics, ACS Medical College and Hospital, Dr MGR Educational and Research Institute, Velappanchavadi, Chennai 600077, Tamil Nadu, India.
Received: February 12, 2025
Revised: April 7, 2025
Accepted: May 18, 2025
Published online: September 20, 2025
Processing time: 181 Days and 14.4 Hours
Revised: April 7, 2025
Accepted: May 18, 2025
Published online: September 20, 2025
Processing time: 181 Days and 14.4 Hours
Core Tip
Core Tip: The double-blinded, randomized controlled trial at Mother Cell Regenerative Centre, Trichy, compares the efficacy and safety of stromal vascular fraction (SVF) vs nanofat in treating primary knee osteoarthritis. Over 18 months, 30 patients will receive either autologous SVF or nanofat injections. Primary outcome is pain reduction at 12 months, while secondary outcomes include functional improvement, cartilage regeneration, and monitoring adverse events. This study aims to provide clinical evidence for these regenerative therapies.