Improvement in Gross Motor Function and Muscle Tone in Children With Cerebral Palsy Related to Neonatal Icterus

Phase 2

Completed

• Conditions: Cerebral Palsy
• Interventions: Combination Product: Stem cell transplantation

• Registration Number: NCT03123562
• Lead Sponsor: Vinmec Research Institute of Stem Cell and Gene Technology

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of stem cells for cerebral palsy related to neonatal icterus

Detailed Description

The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in 25 patients with cerebral palsy related to neonatal icterus at Vinmec International Hospital, Hanoi, Vietnam

Study Timeline

• Study Start: 2014-04-01
• Primary Completion: 2016-09-30
• Study Completion: 2016-10-31
• Study First Submitted: 2017-04-17
• Study First Submitted QC: 2017-04-17
• Study First Posted: 2017-04-21
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-22
• Last Update Posted: 2017-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Cerebral palsy of any types caused by neonatal icterus

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	Stem cell transplantation	Stem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward

Primary Outcome Measures

Name	Time	Method
GMFM-88 and GMFM-66 Percentile	Time Frame: Baseline and 6 months after transplantation	Change in Total Score of Gross Motor Function Measure GMFM-88 and GMFM-66 Percentile

Secondary Outcome Measures

Name	Time	Method
Number of adverse events	Through study completion, an average of 6 months	Examples of adverse events to look for: fever, infections, vomit, epilepsy
Change in Muscle tone	Time Frame: Baseline and 6 months after transplantation	Muscle tone are assessed by Modified Ashworth Scale

Trial Locations

Locations (1)

Vinmec Research Institute of Stem Cell and Gene Technology; 🇻🇳 Hanoi, Vietnam