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
Abstract
BACKGROUND

Cerebral palsy (CP) describes a group of disorders affecting movement, balance, and posture. Disturbances in motor functions constitute the main body of CP symptoms. These symptoms surface in early childhood and patients are affected for the rest of their lives. Currently, treatment involves various pharmacotherapies for different types of CP, including antiepileptics for epilepsy and Botox A for focal spasticity. However, none of these methods can provide full symptom relief. This has prompted researchers to look for new treatment modalities, one of which is mesenchymal stem cell therapy (MSCT). Despite being a promising tool and offering a wide array of possibilities, mesenchymal stem cells (MSCs) still need to be investigated for their efficacy and safety.

AIM

To analyze the efficacy and safety of MSCT in CP patients.

METHODS

Our sample consists of four CP patients who cannot stand or walk without external support. All of these cases received allogeneic MSCT six times as 1 × 106/kg intrathecally, intravenously, and intramuscularly using umbilical cord-derived MSCs (UC-MSC). We monitored and assessed the patients pre- and post-treatment using the Wee Functional Independence Measure (WeeFIM), Gross Motor Function Classification System (GMFCS), and Manual Ability Classification Scale (MACS) instruments. We utilized the Modified Ashworth Scale (MAS) to measure spasticity.

RESULTS

We found significant improvements in MAS scores after the intervention on both sides. Two months: Right χ2 = 4000, P = 0.046, left χ2 = 4000, P = 0.046; four months: Right χ2 = 4000, P = 0.046, left χ2 = 4000, P = 0.046; 12 months: Right χ2 = 4000, P = 0.046, left χ2 = 4000, P = 0.046. However, there was no significant difference in motor functions based on WeeFIM results (P > 0.05). GMFCS and MACS scores differed significantly at 12 months after the intervention (P = 0.046, P = 0.046). Finally, there was no significant change in cognitive functions (P > 0.05).

CONCLUSION

In light of our findings, we believe that UC-MSC therapy has a positive effect on spasticity, and it partially improves motor functions.

Keywords: Cerebral palsy; Mesenchymal stem cell; Transplantation; Wharton’s jelly; Muscle spasticity

Core Tip: Cerebral palsy (CP) describes a group of non-progressive disorders affecting movement, balance, posture, and motor function. Research suggests that stem cell therapy may be a new treatment option in CP. We monitored four CP patients who underwent mesenchymal stem cell therapy (MSCT) for 12 months and analyzed treatment efficacy. MSCT resulted in significantly improved Modified Ashworth Scale, Gross Motor Function Classification System, and Manual Ability Classification System scores.