Clinical Trials Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Stem Cells. Jun 26, 2024; 16(6): 641-655
Published online Jun 26, 2024. doi: 10.4252/wjsc.v16.i6.641
Safety and efficiency of Wharton’s Jelly-derived mesenchymal stem cell administration in patients with traumatic brain injury: First results of a phase I study
Serdar Kabatas, Erdinç Civelek, Osman Boyalı, Gülseli Berivan Sezen, Omer Ozdemir, Yeliz Bahar-Ozdemir, Necati Kaplan, Eyüp Can Savrunlu, Erdal Karaöz
Serdar Kabatas, Erdinç Civelek, Osman Boyalı, Omer Ozdemir, Department of Neurosurgery, University of Health Sciences Turkey, Gaziosmanpaşa Training and Research Hospital, Istanbul 34360, Türkiye
Serdar Kabatas, Center for Stem Cell & Gene Therapy Research and Practice, University of Health Sciences Turkey, Istanbul 34255, Türkiye
Gülseli Berivan Sezen, Department of Neurosurgery, University of Health Sciences, Gaziosmanpaşa Training and Research Hospital, Istanbul 34255, Türkiye
Yeliz Bahar-Ozdemir, Department of Physical Medicine and Rehabilitation, Health Sciences University Sultan Abdulhamid Han Training and Research Hospital, Istanbul 34668, Türkiye
Necati Kaplan, Department of Neurosurgery, Istanbul Rumeli University, Çorlu Reyap Hospital, Tekirdağ 59860, Türkiye
Eyüp Can Savrunlu, Department of Neurosurgery, Nevşehir State Hospital, Nevşehir 50300, Türkiye
Erdal Karaöz, Center for Regenerative Medicine and Stem Cell Research & Manufacturing (LivMedCell), Liv Hospital, Istanbul 34340, Türkiye
Erdal Karaöz, Department of Histology and Embryology, Istinye University, Faculty of Medicine, Istanbul 34010, Türkiye
Erdal Karaöz, Center for Stem Cell and Tissue Engineering Research and Practice, Istinye University, Istanbul 34340, Türkiye
Author contributions: Kabatas S and Civelek E contributed to the concept of this study; Kabatas S, Boyalı O, and Savrunlu EC designed the study; Kabatas S, Civelek E, and Karaöz E were involved in the supervision of this article; Kabatas S, Civelek E, Sezen GB, Kaplan N, and Savrunlu EC participated in the analysis and/or interpretation of this manuscript; Kabatas S, Civelek E, Boyalı O, Sezen GB, Ozdemir O, and Bahar-Ozdemir Y contributed to the literature search related to this study; Kabatas S, Civelek E, Sezen GB, Kaplan N, Bahar-Ozdemir Y, Savrunlu EC, and Karaöz E were involved in manuscript writing; Kabatas S, Civelek E, and Ozdemir O contributed to the critical reviews.
Institutional review board statement: The present study was approved by the medical ethics committee of the authors’ institution (protocol number: 56733164-203-E.12.19).
Clinical trial registration statement: Due to local legal restrictions, separate permission was obtained from the Turkish Ministry of Health for each patient included in the study, and therefore clinical trial registration could not be obtained.
Informed consent statement: Written informed consent was obtained from the patients 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: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Serdar Kabatas, MD, Full Professor, Department of Neurosurgery, University of Health Sciences Turkey, Gaziosmanpaşa Training and Research Hospital, Karayolları Mahallesi, Osmanbey Caddesi 616. Sokak No. 10, Gaziosmanpaşa, Istanbul 34360, Türkiye. kabatasserdar@hotmail.com
Received: January 15, 2024
Revised: February 26, 2024
Accepted: May 9, 2024
Published online: June 26, 2024
Processing time: 161 Days and 16.5 Hours
Core Tip

Core Tip: Traumatic brain injury (TBI) is a disease that particularly affects the young population and causes serious neurological deficits. Current treatment options do not provide the hoped-for improvement in patients. For this reason, many studies are being conducted on new treatment options for TBI. In our phase I study, we present data showing that mesenchymal stem cell applications can be a safe and effective treatment option in this patient group.