Autologous bone marrow mononuclear cell transplant plus rehabilitation for children with brain-injury cerebral palsy
Official title: 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
Run by National Children's Hospital, Vietnam · NCT07527104 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 6 Months to 18 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | National Children's Hospital, Vietnam Academic / other |
| Locations | 1 site (Hanoi, Hanoi) |
| Status | Recruiting |
| Started | December 15, 2025 |
| Main results expected | December 1, 2027 |
| Study ends | April 1, 2028 |
| Registry record updated | April 14, 2026 |
| Trial ID | NCT07527104 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Vietnam National Children's Hospital
Hanoi, Hanoi, Vietnam Recruiting
Study contacts
- Study coordinator: Dat Huu Tran
- Email: drtrandat1986@gmail.com
- Phone: +84987836686
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.