Outcomes of Stem Cells for Cerebral Palsy
Phase 2
Completed
- Conditions
- Cerebral Palsy
- Interventions
- Biological: Autologous Bone Marrow Mononuclear Cells
- Registration Number
- NCT02569775
- 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 40 patients with cerebral palsy at Vinmec International Hospital, Hanoi, Vietnam.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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 Gross Motor Function Measure (GMFM)-66 Percentile 3 months and 6 months after transplantation GMFM-66 percentile
Change in Total Score of Gross Motor Function Measure (GMFM)-88 3 months and 6 months after transplantation GMFM-88
- Secondary Outcome Measures
Name Time Method Change in Muscle tone 3 months and 6 months after transplantation Muscle tone are assessed by Modified Ashworth Scale
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
Trial Locations
- Locations (1)
Vinmec International Hospital
🇻🇳Hanoi, Vietnam