Outcomes of Stem Cells for Cerebral Palsy

Vinmec Healthcare System40 enrolled

Overview

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

The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in 40 patients with cerebral palsy at Vinmec International Hospital, Hanoi, Vietnam.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cerebral Palsy

Interventions

Autologous Bone Marrow Mononuclear CellsBIOLOGICAL

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 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

Locations (1)

Vinmec International Hospital

Hanoi, Vietnam

Outcomes

Primary Outcomes

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

GMFM-88

Time frame: 3 months and 6 months after transplantation

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

GMFM-66 percentile

Time frame: 3 months and 6 months after transplantation

Secondary Outcomes

Change in Muscle tone

Muscle tone are assessed by Modified Ashworth Scale

Time frame: 3 months and 6 months after transplantation

Number of adverse events

Examples of adverse events to look for: anaphylaxis, allergy, respiratory distress, fever, infections, vomit, epilepsy

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

Data from ClinicalTrials.gov

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