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

Vinmec Research Institute of Stem Cell and Gene Technology25 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cerebral Palsy

Interventions

Stem cell transplantationCOMBINATION_PRODUCT

Transplantation of Autologous Bone Marrow Mononuclear Cells

Eligibility

Sex: ALLMin age: 1 YearMax age: 15 Years

Medical Language ↔ Plain English

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

Locations (1)

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, Vietnam

Outcomes

Primary Outcomes

GMFM-88 and GMFM-66 Percentile

Change in Total Score of Gross Motor Function Measure GMFM-88 and GMFM-66 Percentile

Time frame: Time Frame: Baseline and 6 months after transplantation

Secondary Outcomes

Change in Muscle tone

Muscle tone are assessed by Modified Ashworth Scale

Time frame: Time Frame: Baseline and 6 months after transplantation

Number of adverse events

Examples of adverse events to look for: fever, infections, vomit, epilepsy

Time frame: Through study completion, an average of 6 months

Data from ClinicalTrials.gov

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