Outcomes of Stem Cells for Cerebral Palsy

Phase 2

Completed

• Conditions: Cerebral Palsy
• Interventions: Biological: Autologous Bone Marrow Mononuclear Cells

• Registration Number: NCT02574923
• Lead Sponsor: Vinmec Healthcare System

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.

Study Timeline

• Study First Submitted: 2015-10-09
• Study First Submitted QC: 2015-10-09
• Study First Posted: 2015-10-14
• Study Start: 2015-11-05
• Primary Completion: 2018-03-30
• Study Completion: 2018-04-30
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Cerebral palsy of any types caused by oxygen deprivation.

Exclusion Criteria

• Epilepsy
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem cell transplantation	Autologous Bone Marrow Mononuclear Cells	2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 3 months afterward

Primary Outcome Measures

Name	Time	Method
Change in Total Score of Gross Motor Function Measure (GMFM)-88	3 months and 6 months after transplantation	GMFM-88
Change in Gross Motor Function Measure (GMFM)-66 Percentile	3 months and 6 months after transplantation	GMFM-66 percentile

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life	3 months and 6 months after transplantation	Quality of life questionnaire for cerebral palsy (CPQOL)
Number of adverse events	Through study completion, an average of 6 months	Examples of adverse events to look for: anaphylaxis, allergy, respiratory distress, fever, infections, vomit, epilepsy
Change in Denver Developmental Score	3 months and 6 months after transplantation	Denver II
Change in Muscle tone	3 months and 6 months after transplantation	Muscle tone are assessed by Modified Ashworth Scale

Trial Locations

Locations (1)

Vinmec International Hospital; 🇻🇳 Hanoi, Vietnam