Outcomes of Autologous Bone Marrow Mononuclear Cells for Cerebral Palsy: A Self-Controlled Clinical Trial

Vinmec Healthcare System1 site in 1 country30 target enrollmentNovember 5, 2015

ConditionsCerebral Palsy

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Cerebral Palsy
Sponsor: Vinmec Healthcare System
Enrollment: 30
Locations: 1
Primary Endpoint: Change in Total Score of Gross Motor Function Measure (GMFM)-88
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in patients with cerebral palsy.

Detailed Description

The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in 30 patients with cerebral palsy at Vinmec International Hospital, Hanoi, Vietnam.

Registry

clinicaltrials.gov

Start Date

November 5, 2015

End Date

April 30, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Vinmec Healthcare System

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Cerebral palsy of any types caused by oxygen deprivation.

Exclusion Criteria

•Hydrocephalus with ventricular drain
•Coagulation disorders
•Allergy to anesthetic agents
•Severe health conditions such as cancer, failure of heart, lung, liver or kidney
•Active infections

Outcomes

Primary Outcomes

Change in Total Score of Gross Motor Function Measure (GMFM)-88

Time Frame: 3 months and 6 months after transplantation

GMFM-88

Change in Gross Motor Function Measure (GMFM)-66 Percentile

Time Frame: 3 months and 6 months after transplantation

GMFM-66 percentile

Secondary Outcomes

Change in Quality of Life(3 months and 6 months after transplantation)
Change in Denver Developmental Score(3 months and 6 months after transplantation)
Number of adverse events(Through study completion, an average of 6 months)
Change in Muscle tone(3 months and 6 months after transplantation)