Clinical Trials Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Stem Cells. Jan 26, 2024; 16(1): 19-32
Published online Jan 26, 2024. doi: 10.4252/wjsc.v16.i1.19
Effects of exosomes from mesenchymal stem cells on functional recovery of a patient with total radial nerve injury: A pilot study
Erdinç Civelek, Serdar Kabatas, Eyüp Can Savrunlu, Furkan Diren, Necati Kaplan, Demet Ofluoğlu, Erdal Karaöz
Erdinç Civelek, Department of Neurosurgery, University of Health Sciences, Gaziosmanpaşa Training and Research Hospital, Gaziosmanpaşa 34255, Istanbul, Turkey
Serdar Kabatas, Furkan Diren, Department of Neurosurgery, University of Health Sciences Turkey, Gaziosmanpaşa Training and Research Hospital, Gaziosmanpaşa 34255, Istanbul, Turkey
Serdar Kabatas, Center for Stem Cell & Gene Therapy Research and Practice, University of Health Sciences Turkey, Gaziosmanpaşa 34255, Istanbul, Turkey
Eyüp Can Savrunlu, Department of Neurosurgery, Nevşehir State Hospital, Nevşehir 50300, Turkey
Necati Kaplan, Department of Neurosurgery, Istanbul Rumeli University, Çorlu Reyap Hospital, Çorlu 59860, Tekirdağ, Turkey
Demet Ofluoğlu, Department of Physical Medicine and Rehabilitation, Ofluoğlu Klinik, Göztepe 34728, Istanbul, Turkey
Erdal Karaöz, Liv Hospital, Center for Regenerative Medicine and Stem Cell Research & Manufacturing (LivMedCell), Beşiktaş 34340, Istanbul, Turkey
Erdal Karaöz, Department of Histology and Embryology, Istinye University, Faculty of Medicine, Zeytinburnu 34010, Istanbul, Turkey
Erdal Karaöz, Istinye University, Center for Stem Cell and Tissue Engineering Research and Practice, Beşiktaş 34340, Istanbul, Turkey
Author contributions: Civelek E, Kabatas S, and Karaöz E concepted this study and contributed to the supervision of this article; Civelek E, Kabatas S, Savrunlu EC, and Diren F designed this study; Civelek E, Kabatas S, Savrunlu EC, Diren F, Kaplan N, and Ofluoğlu D participated in the analysis and/or interpretation of this manuscript; Civelek E, Kabatas S, Savrunlu EC, Diren F, and Ofluoğlu D took part in the literature search; Civelek E, Kabatas S, Savrunlu EC, Diren F, and Karaöz E wrote the manuscript; Civelek E, Kabatas S, Savrunlu EC, and Ofluoğlu D contributed to the critical reviews of this article.
Institutional review board statement: The present study was approved by the medical ethics committee of the authors’ institution (protocol number: 56733164-203-E.5863).
Clinical trial registration statement: Our study is a pilot study, not a randomized controlled study. Therefore, the study was not registered. We aim for this study to be a pioneer for the randomized studies we will conduct in the future. We will register the randomized controlled studies we will conduct through the system prior the enrollment.
Informed consent statement: There is human subject in this article and written informed consents were obtained from the patient for their anonymized information to be published in this article and before the stem cell therapies.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: No additional data are available.
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:
Corresponding author: Erdinç Civelek, MD, Full Professor, Department of Neurosurgery, University of Health Sciences, Gaziosmanpaşa Training and Research Hospital, Karayolları Mahallesi, Osmanbey Caddesi 616. Sokak No. 10, Gaziosmanpaşa 34255, Istanbul, Turkey.
Received: October 23, 2023
Peer-review started: October 23, 2023
First decision: November 13, 2023
Revised: November 30, 2023
Accepted: January 5, 2024
Article in press: January 5, 2024
Published online: January 26, 2024
Research background

Poor functional outcome after surgery is a great challenge in peripheral nerve injury (PNI). Surgical treatments fail to address the complexity of the events that occur following a PNI. There is a clear clinical need to find new approaches. Exosomas from Wharton’s jelly-derived mesenchymal stem cells (WJ-MSCs). have the ability to accelerate the improvement of nerve regeneration.

Research motivation

The therapeutic results of exosome application in PNI require investigation.

Research objectives

This study aimed to determine the effects of treatment of peripheral nerve damage with sural autograft and perioperative exosome application.

Research methods

The patient, with total radial nerve injury, underwent a sural autograft repair followed by the per-operative subepineural application of MSC-derived exosome (WJ-MSCs). The patient was monitored for 180 d with neurological examination and electrodiagnostic testing.

Research results

Although physical therapy was not applied after the procedure, improvement in motor and sensory functions occurred in an unusually short time. The nerve exhibited re-innervation signs as evidenced by control electromyography (EMG) at the 10th wk post-injury, and a significant electrophysiological enhancement was observed in the EMG conducted at the 6th-mo follow-up, indicating ongoing regeneration.

Research conclusions

Exosomes (WJ-MSCs) can accelerate the recovery in the treatment of peripheral nerve damage and lead to the improvement in functional outcome.

Research perspectives

New strategies to improve the functional outcome after PNI treatment should be the focus of future studies which can help in increasing the chances of using exosomes clinically for the treatment of PNI.