Prospective Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Orthop. May 18, 2024; 15(5): 457-468
Published online May 18, 2024. doi: 10.5312/wjo.v15.i5.457
Efficacy of stromal vascular fraction for knee osteoarthritis: A prospective, single-centre, non-randomized study with 2 years follow-up
Madhan Jeyaraman, Naveen Jeyaraman, Tarun Jayakumar, Swaminathan Ramasubramanian, Rajni Ranjan, Saurabh Kumar Jha, Ashim Gupta
Madhan Jeyaraman, Naveen Jeyaraman, Department of Orthopaedics, ACS Medical College and Hospital, Dr MGR Educational and Research Institute, Chennai, Tamil Nadu 600077, India
Madhan Jeyaraman, Saurabh Kumar Jha, Department of Biotechnology, School of Engineering and Technology, Sharda University, Greater Noida, Uttar Pradesh 201310, India
Madhan Jeyaraman, Ashim Gupta, Department of Orthopaedics and Regenerative Medicine, South Texas Orthopaedic Research Institute, Laredo, TX 78045, United States
Tarun Jayakumar, Department of Orthopaedics, KIMS-Sunshine Hospital, Hyderabad, Telangana 500032, India
Swaminathan Ramasubramanian, Department of Orthopaedics, Government Medical College, Omandurar Government Estate, Chennai, Tamil Nadu 600002, India
Rajni Ranjan, Department of Orthopaedics, School of Medical Sciences and Research, Sharda University, Greater Noida, Uttar Pradesh 201306, India
Saurabh Kumar Jha, Department of Zoology, Kalindi College, University of Delhi, New Delhi 110008, India
Ashim Gupta, Department of Orthopaedics and Regenerative Medicine, Regenerative Orthopaedics, Noida 201301, Uttar Pradesh, India
Ashim Gupta, Department of Orthopaedics and Regenerative Medicine, Future Biologics, Lawrenceville, GA 30043, United States
Ashim Gupta, Department of Orthopaedics and Regenerative Medicine, BioIntegrate, Lawrenceville, GA 30043, United States
Co-corresponding authors: Madhan Jeyaram and Saurabh Kumar Jha.
Author contributions: Jeyaraman M and Jha SK contributed to conceptualization; Jeyaraman M, Jeyaraman N, and Ranjan R contributed to patient screening, acquired clinical data, performed the desired investigation and follow-up; Jeyaraman M, Jayakumar T, and Ramasubramanian S contributed to manuscript writing; Gupta A contributed to manuscript revision; Jeyaraman M, Gupta A, and Jha SK contributed to proofreading; Jha SK contributed to administration. All the authors have read and approved the final manuscript. Jeyaraman M and Jha SK have played important and indispensable roles in the experimental design, data interpretation and manuscript preparation as the co-corresponding authors. The collaboration between Jeyaraman M and Jha SK is crucial for the publication of this manuscript and other manuscripts still in preparation.
Institutional review board statement: The study was conducted following the Declaration of Helsinki and approved by the Ethics Committee of the School of Medical Sciences and Research, Sharda University (Ref no. SU/SMS&R/76-A/2021/113).
Informed consent statement: All study participants, or their legal guardian, provided written consent prior to study enrollment.
Conflict-of-interest statement: All authors of this manuscript having no conflicts of interest to disclose.
Data sharing statement: The data is contained within the manuscript.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
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, Chennai, Tamil Nadu 600077, India. madhanjeyaraman@gmail.com
Received: January 23, 2024
Revised: March 21, 2024
Accepted: April 18, 2024
Published online: May 18, 2024
Abstract
BACKGROUND

Current osteoarthritis (OA) treatments focus on symptom relief without addressing the underlying disease process. In regenerative medicine, current treatments have limitations. In regenerative medicine, more research is needed for intra-articular stromal vascular fraction (SVF) injections in OA, including dosage optimization, long-term efficacy, safety, comparisons with other treatments, and mechanism exploration.

AIM

To compare the efficacy of intra-articular SVF with corticosteroid (ICS) injections in patients with primary knee OA.

METHODS

The study included 50 patients with Kellgren-Lawrence grades II and III OA. Patients were randomly assigned (1:1) to receive either a single intra-articular SVF injection (group A) or a single intra-articular ICS (triamcinolone) (group B) injection. Patients were followed up at 1, 3, 6, 12, and 24 months. Visual analog score (VAS) and International Knee Documentation Committee (IKDC) scores were administered before the procedure and at all follow-ups. The safety of SVF in terms of adverse and severe adverse events was recorded. Statistical analysis was performed with SPSS Version 26.0, IBM Corp, Chicago, IL, United States.

RESULTS

Both groups had similar demographics and baseline clinical characteristics. Follow-up showed minor patient loss, resulting in 23 and 24 in groups A and B respectively. Group A experienced a notable reduction in pain, with VAS scores decreasing from 7.7 to 2.4 over 24 months, compared to a minor reduction from 7.8 to 6.2 in Group B. This difference in pain reduction in group A was statistically significant from the third month onwards. Additionally, Group A showed significant improvements in knee functionality, with IKDC scores rising from 33.4 to 83.10, whereas Group B saw a modest increase from 36.7 to 45.16. The improvement in Group A was statistically significant from 6 months and maintained through 24 months.

CONCLUSION

Our study demonstrated that intra-articular administration of SVF can lead to reduced pain and improved knee function in patients with primary knee OA. More adequately powered, multi-center, double-blinded, randomised clinical trials with longer follow-ups are needed to further establish safety and justify its clinical use.

Keywords: Knee osteoarthritis, Adipose tissue, Stromal vascular fraction, Regenerative medicine, Orthobiologics

Core Tip: The clinical study presents a comprehensive analysis of the efficacy of stromal vascular fraction (SVF) in managing knee osteoarthritis, highlighting its superiority over corticosteroid injections in reducing pain and improving joint function. The research emphasizes the need for standardizing SVF therapy protocols to enhance its clinical application.