Bone Marrow Cell Transplant Tested for Cerebral Palsy From Brain Oxygen Loss
Tests bone marrow cell infusions in children aged 1 to 10 with spastic cerebral palsy.
Plain-language title generated from the registry record
Registry title: Evaluating Bone Marrow Cell Transplant for Treating Cerebral Palsy From Brain Hypoxia
Key facts
- Where
- Hanoi, VietnamSee the 2 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 10 years old?
Source: NCT06629324, who can take part
Where in Vietnam
- Vinmec research Institute and Gene TechnologyHanoi, VietnamTaking people
- Vinmec Research Institute of Stem Cell and Gene TechnologyHanoi, VietnamNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vinmec Research Institute of Stem Cell and Gene Technology
- Trial code
- NCT06629324
- Record updated
- 22 January 2026
- Original description
This clinical trial aims to evaluate the effectiveness of autologous bone marrow mononuclear cell transfusion in treating cerebral palsy caused by cerebral hypoxia.Read full original descriptionShow less
Evaluation of the Efficacy of Autologous Bone Marrow-Derived Mononuclear Cell Transplantation in the Treatment of Cerebral Palsy Due to Brain Hypoxia: A Phase II Randomized Clinical Trial
This clinical trial aims to evaluate the effectiveness of autologous bone marrow mononuclear cell transfusion in treating cerebral palsy caused by cerebral hypoxia.
The key questions the study seeks to answer are:
* What is the safety profile in terms of adverse events (AE) and serious adverse events (SAE) observed over the 9 months following the first transplantation? * How does autologous bone marrow mononuclear cell (BM MNC) transplantation impact the gross motor function (GMFM-88) scores and Gross Motor Function Classification System (GMFCS) scores in children with cerebral palsy? * How does autologous BM MNC transplantation influence muscle tone (Modified Ashworth Scale score) and hand motor function (MACS/Mini-MACS scale) in children with cerebral palsy, 9 months post the initial transplantation?
Fifty-eight selected patients, aged 1 to 10 years and diagnosed with spastic cerebral palsy due to brain hypoxia, will be randomly divided into two groups:
* Group A: will receive two BM MNC infusions with the first at baseline and the second at 6 months ± 21 days (T6) via the spinal route. * Group B: will serve as the control group for the first 9 months. During this period, patients will not receive cell transplantation but will undergo a similar rehabilitation and medication regimen as Group A. After 9 months, Group B will receive two BM MNC infusions: the first at 9 months ± 21 days (T9) and the second at 15 months ± 21 days (T15) via the spinal route, with a follow-up at 18 months ± 21 days (T18) compared to baseline. * Both groups: will undergo rehabilitation for 10 days per month, three times, either at rehabilitation centers or performed by a rehabilitation technician at home. After this period, continued training will be conducted by family members. The combined medication regimen will include muscle relaxants (if muscle spasticity is present), vitamins, and neuroprotective drugs (Piracetam).
Inclusion: Age from 1 to 10 years, both genders; Gross Motor Function Classification System (GMFCS): levels II to V; Spastic cerebral palsy due to brain hypoxia.
Exclusion: Coagulation disorders; Severe health conditions such as cachexia, heart failure, lung, liver, or kidney failure; or active infections; Cancer; HIV positive, active viral hepatitis; Hemoglobin below 110 g/L; Spinal injuries prevent the placement of a catheter through the spinal cavity.