Clinical Trials Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Mar 26, 2024; 12(9): 1585-1596
Published online Mar 26, 2024. doi: 10.12998/wjcc.v12.i9.1585
Allogeneic mesenchymal stem cells may be a viable treatment modality in cerebral palsy
Osman Boyalı, Serdar Kabatas, Erdinç Civelek, Omer Ozdemir, Yeliz Bahar-Ozdemir, Necati Kaplan, Eyüp Can Savrunlu, Erdal Karaöz
Osman Boyalı, Serdar Kabatas, Erdinç Civelek, Omer Ozdemir, Department of Neurosurgery, University of Health Sciences Turkey, Gaziosmanpaşa Training and Research Hospital, Istanbul 34360, Turkey
Serdar Kabatas, Center for Stem Cell & Gene Therapy Research and Practice, University of Health Sciences Turkey, Istanbul 34360, Turkey
Yeliz Bahar-Ozdemir, Department of Physical Medicine and Rehabilitation, Health Sciences University Sultan Abdulhamid Han Training and Research Hospital, Istanbul 34668, Turkey
Necati Kaplan, Department of Neurosurgery, Istanbul Rumeli University, Çorlu Reyap Hospital, Tekirdağ 59860, Turkey
Eyüp Can Savrunlu, Department of Neurosurgery, Nevşehir State Hospital, Nevşehir 50300, Turkey
Erdal Karaöz, Center for Regenerative Medicine and Stem Cell Research & Manufacturing (LivMedCell), Liv Hospital, Istanbul 34340, Turkey
Erdal Karaöz, Department of Histology and Embryology, Istinye University, Faculty of Medicine, İstanbul 34010, Turkey
Erdal Karaöz, Center for Stem Cell and Tissue Engineering Research and Practice, Istinye University, Istanbul 34340, Turkey
Author contributions: Boyali O, Civelek E, and Kabatas S contributed to concept; Osman Boyali, Kabatas S, and Savrunlu EC contributed to design; Boyali O, Kabatas S, and Karaoz E contributed to supervision; Civelek E, Kabatas S, Savrunlu EC, and Kaplan N contributed to analysis and/or interpretation; Boyali O, Kabatas S, Civelek E, Savrunlu EC, Ozdemir O, and Ozdemir YB contributed to literature search; Boyali O, Civelek E, Kabatas S, Kaplan N, Savrunlu EC, Ozdemir YB, and Karaoz E contributed to writing; Boyali O, Civelek E, Kabatas S, and Ozdemir O contributed to critical reviews.
Institutional review board statement: The present study was approved by the medical ethics committee of the authors' institution, No. 56733164-203-E.3178.
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: All study participants or their legal guardian provided informed written consent regarding personal and medical data collection prior to study enrolment.
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: Osman Boyalı, MD, Neurosurgeon, Department of Neurosurgery, University of Health Sciences Turkey, Gaziosmanpaşa Training and Research Hospital, Karayolları Mahallesi, Osmanbey Caddesi 616. Sokak No. 10 Gaziosmanpaşa, Istanbul 34360, Turkey. drosmanboyali@gmail.com
Received: November 29, 2023
Peer-review started: November 29, 2023
First decision: December 12, 2023
Revised: January 11, 2024
Accepted: February 28, 2024
Article in press: February 28, 2024
Published online: March 26, 2024
Processing time: 116 Days and 8.3 Hours
ARTICLE HIGHLIGHTS

Cerebral palsy (CP) describes a group of nonprogressive disorders affecting movement, posture, and motor functions. It occurs in early childhood and persists until the end of life. Currently, the treatment of CP involves numerous modalities, such as various surgical treatments (selective dorsal rhizotomy, selective peripheral neurotomy, etc.), pharmacotherapies for generalized spasticity, Botox A for focal spasticity, and antiepileptics for epilepsy.

Research motivation

Current modalities can only provide partial symptom relief, which warrants research into new methods. One novel option for treating CP is mesenchymal stem cell therapy.

Research objectives

We aimed to investigate the efficacy and safety of mesenchymal stem cell therapy in CP cases.

Research methods

Our sample consisted of four patients who were unable to stand or walk without external support. All cases received allogeneic mesenchymal stem cell therapy six times as 1 × 106/kg intrathecally, intravenously, and intramuscularly using umbilical cord-derived mesenchymal stem cells. We monitored the patients before and after the treatment using the Wee Functional Independence Measure, the Gross Motor Function Classification System, the Manual Ability Classification Scale, and the Modified Ashworth Scale.

Research results

Spasticity measures showed significant improvement in both sides after the intervention. There was no significant change in motor functions or cognitive functions. Gross motor function and manual ability measures differed statistically significantly at 12 months after treatment compared to baseline values.

Research conclusions

In light of our findings, umbilical cord-derived mesenchymal stem cell therapy shows positive effects on spasticity and partial improvement in motor functions.

Research perspectives

In this study, we demonstrated that allogeneic mesenchymal stem cell application via intrathecal, intramuscular and intravenous routes is safe and effective in cerebral palsy patients. The effectiveness of this treatment protocol should be evaluated at a higher level of evidence by conducting randomized, double-blind, case-control studies with a high number of participants in the future.