Outcomes of Autologous Bone Marrow Mononuclear Cells for Cerebral Palsy: A Self-Controlled Clinical Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in Total Score of Gross Motor Function Measure (GMFM)-88
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Stem cell transplantation
2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 3 months afterward
Intervention: Autologous Bone Marrow Mononuclear Cells (Biological)
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)