Jeyaraman N, Shrivastava S, Rangarajan RV, Nallakumarasamy A, Ramasubramanian S, Devadas AG, Rupert S, Jeyaraman M. Challenges in the clinical translation of stromal vascular fraction therapy in regenerative medicine. World J Stem Cells 2025; 17(6): 103775 [DOI: 10.4252/wjsc.v17.i6.103775]
Corresponding Author of This Article
Madhan Jeyaraman, Department of Orthopaedics, ACS Medical College and Hospital, Dr MGR Educational and Research Institute, Velappanchavadi, Chennai 600077, Tamil Nadu, India. madhanjeyaraman@gmail.com
Research Domain of This Article
Cell & Tissue Engineering
Article-Type of This Article
Review
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (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: http://creativecommons.org/licenses/by-nc/4.0/
World J Stem Cells. Jun 26, 2025; 17(6): 103775 Published online Jun 26, 2025. doi: 10.4252/wjsc.v17.i6.103775
Challenges in the clinical translation of stromal vascular fraction therapy in regenerative medicine
Naveen Jeyaraman, Sandeep Shrivastava, Ravi Velamoor Rangarajan, Arulkumar Nallakumarasamy, Swaminathan Ramasubramanian, Avinash Gandi Devadas, Secunda Rupert, Madhan Jeyaraman
Naveen Jeyaraman, Sandeep Shrivastava, Arulkumar Nallakumarasamy, Department of Orthopaedics, Datta Meghe Institute of Higher Education and Research, Wardha 442004, Maharashtra, India
Naveen Jeyaraman, Ravi Velamoor Rangarajan, Arulkumar Nallakumarasamy, Swaminathan Ramasubramanian, Avinash Gandi Devadas, Madhan Jeyaraman, Department of Regenerative Medicine, Mother Cell Regenerative Centre, Tiruchirappalli 620017, Tamil Nadu, India
Secunda Rupert, Department of Regenerative Medicine and Research, Government Stanley Hospital, Chennai 600001, 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 study; Jeyaraman N and Nallakumarasamy A analyzed the articles for review; Jeyaraman N, Nallakumarasamy A, and Ramasubramanian S wrote the manuscript; Shrivastava S, Rangarajan RV, Devadas AG, Rupert S, and Jeyaraman M finalized the manuscript.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
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, Department of Orthopaedics, ACS Medical College and Hospital, Dr MGR Educational and Research Institute, Velappanchavadi, Chennai 600077, Tamil Nadu, India. madhanjeyaraman@gmail.com
Received: December 3, 2024 Revised: March 13, 2025 Accepted: May 7, 2025 Published online: June 26, 2025 Processing time: 208 Days and 1.2 Hours
Abstract
Stromal vascular fraction (SVF) therapy is a promising regenerative medicine strategy derived from adipose tissue, containing a heterogeneous mix of cells, including adipose-derived stem, endothelial, and immune cells. Despite its potential in treating conditions like osteoarthritis, chronic wounds, and myocardial ischemia, significant challenges impede its clinical translation. Key obstacles include biological variability in SVF composition, unclear mechanisms of action, regulatory ambiguities, and the technical difficulty of ensuring standardized and scalable isolation methods. Furthermore, patient-specific factors, ethical concerns, and the need for comprehensive efficacy assessment complicate clinical application. Addressing these challenges requires advancements in technology, regulatory flexibility, interdisciplinary collaboration, and personalized therapeutic approaches. Innovations such as automated isolation systems, advanced biomaterials, and CRISPR-based gene editing are potential solutions to improve the therapeutic reliability of SVF. A structured roadmap, including preclinical research, regulatory approval, and post-market surveillance, is proposed to advance SVF therapies from the laboratory to clinical practice. Future directions should focus on large-scale clinical trials, biomarker development, real-world evidence generation, and standardization of protocols to enhance the safety, efficacy, and accessibility of SVF, ultimately realizing its potential as a versatile therapeutic in regenerative medicine.
Core Tip: Stromal vascular fraction (SVF) therapy, derived from adipose tissue and containing a mix of cells, shows promise in treating conditions like osteoarthritis and chronic wounds. However, challenges such as biological variability, unclear mechanisms, regulatory issues, and scalability hinder clinical translation. Addressing these challenges requires technological advancements, regulatory flexibility, and interdisciplinary collaboration. Innovations like automated isolation, advanced biomaterials, and CRISPR-based editing could enhance reliability. A structured roadmap, including preclinical research and large-scale trials, is essential to advance SVF therapies. Future efforts should focus on standardizing protocols and generating real-world evidence to maximize the potential of SVF in regenerative medicine.