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01.12.2017 | Research article | Ausgabe 1/2017 Open Access

BMC Pediatrics 1/2017

Outcomes of autologous bone marrow mononuclear cells for cerebral palsy: an open label uncontrolled clinical trial

Zeitschrift:
BMC Pediatrics > Ausgabe 1/2017
Autoren:
Liem Thanh Nguyen, Anh Tuan Nguyen, Chinh Duy Vu, Doan V. Ngo, Anh V. Bui
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s12887-017-0859-z) contains supplementary material, which is available to authorized users.

Abstract

Background

Stem cell therapy has emerged as a promising method for improving motor function of patients with cerebral palsy. The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cell transplantation in patients with cerebral palsy related to oxygen deprivation.

Methods

An open label uncontrolled clinical trial was carried out at Vinmec International Hospital. The intervention consisted of two administrations of stem cells, the first at baseline and the second 3 months later. Improvement was monitored at 3 months and 6 months after the first administration of stem cells, using the Gross Motor Function Measure (GMFM) and Modified Ashworth Score which measures muscle tone.

Results

No severe complications were recorded during the study. After transplantation, 12 patients encountered fever without infections and 9 patients experienced vomiting which was easily managed with medications. Gross motor function was markedly improved 3 months or 6 months after stem cell transplantation than at baseline. The post-transplantation GMFM-88 total score, each of its domains and the GMFM-66 percentile were all significantly higher (p-value < 0.001). Muscle spasticity also reduced significantly after transplantation (p-value < 0.001). The therapy was equally effective regardless of sex, age and GMFCS level (p-value > 0.05).

Conclusion

Autologous bone marrow mononuclear cell transplantation appears to be a safe and effective therapy for patients with cerebral palsy.

Trial registration

ClinicalTrials.​gov Identifier: NCT02569775. Retrospectively registered on October 15, 2015.
Zusatzmaterial
Additional file 1: Stem cell transplantation for cerebral palsy. This is a dataset file of study on autologous bone marrow mononuclear cells for cerebral palsy. The data includes demographic data, gross motor function of patients with cerebral palsy such as GMFM-88 total score, GMFM-66 percentile, and complication figures. The dataset consists of 40 observations and 44 variables (XLSX 51 kb)
12887_2017_859_MOESM1_ESM.xlsx
Literatur
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