Autologous bone marrow mononuclear cell transplant plus rehabilitation for children with brain-injury cerebral palsy
A Randomized Controlled Trial Evaluating the Efficacy and Safety of Autologous Bone Marrow-Derived Mononuclear Cell Transplantation Combined With Rehabilitation in Children With Sequelae of Hypoxic-Ischemic Encephalopathy or Intracranial Hemorrhage
Researchers will test whether giving children aged 12–72 months with cerebral palsy from hypoxic-ischemic injury or intracranial hemorrhage an intrathecal transplant of their own bone marrow mononuclear cells combined with rehabilitation improves function compared with rehabilitation alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 6 Months to 18 Years |
| Sex | All |
| Sponsor | National Children's Hospital, Vietnam Academic / other |
| Locations | 1 site (Hanoi, Hanoi) |
| Trial ID | NCT07527104 on ClinicalTrials.gov |
What this trial studies
Children aged 12–72 months with cerebral palsy caused by hypoxic-ischemic brain injury or intracranial hemorrhage and GMFCS III–V are enrolled and assigned to an intervention group receiving autologous bone marrow aspiration, intrathecal mononuclear cell transplantation, and a standardized rehabilitation program, or to a control group receiving the same rehabilitation alone. The phase II interventional protocol focuses on safety and preliminary efficacy with scheduled follow-up assessments to compare neurological and motor outcomes between groups. Key procedures include bone marrow collection under anesthesia, processing to isolate mononuclear cells, intrathecal injection of autologous cells, and guided rehabilitation sessions. The study also aims to develop a standardized technical protocol for the transplantation approach.
Who should consider this trial
Good fit: Ideal candidates are children aged 12 to 72 months with cerebral palsy due to hypoxic-ischemic encephalopathy or intracranial hemorrhage, at GMFCS levels III–V, who can undergo bone marrow aspiration and participate in rehabilitation, with informed parental consent.
Not a fit: Children with cerebral palsy from other causes, those with milder disability (GMFCS I–II), or those with contraindications to anesthesia, bone marrow aspiration, or intrathecal procedures are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could offer additional neuroregenerative benefit and improve motor function and daily activities for children who do not fully recover with rehabilitation alone.
How similar studies have performed: Small early-phase studies and case series of autologous bone marrow mononuclear cell transplantation in pediatric cerebral palsy have reported preliminary safety and some functional gains, but larger controlled trials remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children diagnosed with cerebral palsy * Age from 12 months to 72 months * Cerebral palsy caused by hypoxic-ischemic brain injury or intracranial hemorrhage * Gross Motor Function Classification System (GMFCS) level III to V * Completed required laboratory tests according to the study protocol * Written informed consent obtained from the child's parent or legal guardian Exclusion Criteria: * Children with acute infection at the time of screening or enrollment * Children with severe coagulopathy or contraindications to bone marrow aspiration * Children with severe systemic diseases (e.g., severe cardiac, hepatic, or renal failure) * Children with contraindications to anesthesia or intrathecal transplantation procedures * Children with a history of malignancy * Children who are unable to participate in or complete the rehabilitation program * Parents or legal guardians who do not provide informed consent
Where this trial is running
Hanoi, Hanoi
- Vietnam National Children's Hospital — Hanoi, Hanoi, Vietnam (Recruiting)
Study contacts
- Study coordinator: Dat Huu Tran
- Email: drtrandat1986@gmail.com
- Phone: +84987836686
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.