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Autologous Bone Marrow Mononuclear Cell Transplantation Combined With Rehabilitation in Children With Sequelae of Hypoxic-Ischemic Encephalopathy or Intracranial Hemorrhage
Sponsor: National Children's Hospital, Vietnam
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.
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
Key Details
Gender
All
Age Range
6 Months - 18 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-12-15
Completion Date
2028-04-01
Last Updated
2026-04-14
Healthy Volunteers
No
Interventions
Autologous Bone Marrow Mononuclear Cell Transplantation
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)
Vietnam National Children's Hospital
Hanoi, Hanoi, Vietnam