Autologous Bone Marrow Mononuclear Cell Transplantation Combined With Rehabilitation in Children With Sequelae of Hypoxic-Ischemic Encephalopathy or Intracranial Hemorrhage

Recruiting now · Not applicable

Conditions studied: Cerebral Palsy Hypoxic-Ischemic Encephalopathy Intracranial Hemorrhage

In brief

This study evaluates the safety and preliminary efficacy of autologous bone marrow mononuclear cell transplantation combined with rehabilitation in children with neurological sequelae caused by hypoxic-ischemic brain injury or intracranial hemorrhage. Participants in the intervention group will receive autologous bone marrow aspiration, mononuclear cell transplantation via intrathecal route, and rehabilitation, while the control group will receive rehabilitation alone. Outcomes will be compared between groups over follow-up time points.

Key facts

Study ID

NCT07527104

Run by

National Children's Hospital, Vietnam

People needed

60

Starts

2025-12-15

Expected to finish

2028-04-01

Last updated by the study team

2026-04-14

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Vietnam National Children's Hospital — Hanoi, Hanoi, Vietnam (enrolling)

Full record on ClinicalTrials.gov

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