Autologous Bone Marrow Mononuclear Cell Transplantation Combined With Rehabilitation in Children With Sequelae of Hypoxic-Ischemic Encephalopathy or Intracranial Hemorrhage
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
National Children's Hospital, Vietnam
60 participants
Dec 15, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria7
- 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
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Interventions
Autologous bone marrow mononuclear cells (BMMNCs) are collected from the patient's iliac crest under sterile conditions. Bone marrow aspiration is performed under appropriate anesthesia, followed by processing to isolate mononuclear cells using density gradient centrifugation. The prepared BMMNCs are administered via intrathecal injection under aseptic conditions. The dosage of cells is determined based on body weight and viability criteria. Patients are monitored for immediate and delayed adverse events following transplantation. In addition to cell transplantation, participants receive standardized rehabilitation therapy, including physical therapy, occupational therapy, and neurodevelopmental interventions, according to institutional protocols. This combined intervention aims to enhance neurological recovery through both regenerative cellular therapy and functional rehabilitation.
Locations(1)
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NCT07527104