Observational Study
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Exp Med. Sep 20, 2025; 15(3): 107323
Published online Sep 20, 2025. doi: 10.5493/wjem.v15.i3.107323
Safety and efficacy of autologous bone marrow aspirate concentrate injection for idiopathic male infertility: A comparative study
Ravi Velamoor Rangarajan, Avinash Gandi Devadas, Dhossaradhan Jayakumar Padmanapan, Naveen Jeyaraman, Swaminathan Ramasubramanian, Arulkumar Nallakumarasamy, Sathish Muthu, Madhan Jeyaraman
Ravi Velamoor Rangarajan, Avinash Gandi Devadas, Dhossaradhan Jayakumar Padmanapan, Naveen Jeyaraman, Swaminathan Ramasubramanian, Arulkumar Nallakumarasamy, Sathish Muthu, Madhan Jeyaraman, Department of Regenerative Medicine, Mother Cell Regenerative Centre, Tiruchirappalli 620017, Tamil Nadu, India
Author contributions: Ravi VR designed the research; Devadas AG and Padmanapan DJ performed data collection; Ravi VR, Ramasubramanian S, Muthu S, and Jeyaraman M finalized the manuscript; Jeyaraman N, Ramasubramanian S, Nallakumarasamy A, Muthu S, and Jeyaraman M analyzed the articles for performing review and wrote the manuscript; All of the authors read and approved the final version of the manuscript to be published.
Institutional review board statement: The study was reviewed and approved by the Ethics Committee.
Informed consent statement: All participants provided informed consent.
Conflict-of-interest statement: All authors declare no conflict of interest in publishing the manuscript.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Data sharing statement: All 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, MS, PhD, Assistant Professor, Research Associate, Department of Regenerative Medicine, Mother Cell Regenerative Centre, Vayalur, Tiruchirappalli 620017, Tamil Nadu, India. madhanjeyaraman@gmail.com
Received: March 21, 2025
Revised: March 29, 2025
Accepted: April 21, 2025
Published online: September 20, 2025
Processing time: 145 Days and 4.3 Hours
Abstract
BACKGROUND

Although limited clinical evidence exists, such as case reports of azoospermia treatment in humans using bone marrow aspirate concentrate (BMAC) injection, these findings provide a compelling foundation for exploring mesenchymal stem cell therapy in male infertility.

AIM

To evaluate the safety and efficacy of autologous BMAC injection into human testis for men with severe oligospermia or azoospermia over the existing standard of care pharmacotherapy and lifestyle modifications.

METHODS

We included patients diagnosed with male infertility of the age group between 35–45 years in this trial comparing BMAC injection therapy with pharmacotherapy and lifestyle modifications over a 6-month follow-up period. Semen analysis was used to evaluate the efficacy of the interventions analyzed.

RESULTS

We enrolled 30 patients in the trial with 10 patients in each arm of the trial. Compared to the baseline, neither the BMAC group (P = 0.139) or pharmacotherapy group (P = 0.056) nor the lifestyle modification group (P = 0.112) demonstrated a statistically significant increase in sperm count at 6 months. However, the BMAC group demonstrated a significant increase in sperm count (mean 19.2 million; P = 0.001) compared to the pharmacotherapy group (mean 3.5 million) and lifestyle modification group (mean 2.2 million) at 6 months. Significant improvement was noted in the motility grade (P < 0.001) only in the BMAC group while no changes were noted in the other groups.

CONCLUSION

This trial highlights the potential of autologous BMAC as a promising therapeutic option for male infertility. Despite the absence of significant changes within individual treatment arms, BMAC therapy demonstrated superior efficacy in improving both sperm count and motility compared to standard pharmacotherapy and lifestyle modifications. These findings underscore the potential role of regenerative medicine in addressing severe oligospermia and azoospermia, warranting further research to solidify its clinical applicability.

Keywords: Bone marrow aspirate concentrate; Male infertility; Sperm count; Motility; Regenerative medicine

Core Tip: This trial evaluated the safety and efficacy of autologous bone marrow aspirate concentrate (BMAC) therapy for male infertility in men aged 35–45 with severe oligospermia or azoospermia. Over six months, BMAC therapy showed a significant increase in sperm count and motility compared to pharmacotherapy and lifestyle modifications. These results highlight BMAC's potential as a regenerative medicine option for male infertility, warranting further research for clinical application.