Autologous Bone Marrow Mononuclear Cell Transplantation Combined With Rehabilitation in Children With Sequelae of Hypoxic-Ischemic Encephalopathy or Intracranial Hemorrhage
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Autologous Bone Marrow Mononuclear Cell Transplantation.
- Who it may be relevant to
- Registry conditions: Cerebral Palsy Hypoxic-Ischemic Encephalopathy Intracranial Hemorrhage. Basic parameters: 6 months — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Vietnam
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Detailed description
Neurological sequelae following hypoxic-ischemic brain injury and intracranial hemorrhage in children remain a major clinical challenge with limited effective treatment options. Rehabilitation is the current standard of care but often results in incomplete recovery. Autologous bone marrow mononuclear cell transplantation has emerged as a promising therapeutic approach due to its potential neuroregenerative and neuroprotective effects. This phase II study aims to evaluate the safety and preliminary efficacy of combining autologous bone marrow mononuclear cell transplantation with rehabilitation compared to rehabilitation alone. The study will also contribute to the development of a standardized technical protocol for this intervention.
Interventions
- Procedure 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 adve
Primary outcome measures
- Change in Gross Motor Function Measure (GMFM-88) total score from baseline to 12 months [Time frame: Baseline and 12 months]
Secondary outcome measures (4)
- Change in GMFM score at 3, 6, 9 months [Time frame: Baseline and 3, 6, 9 months]
- Change in Gross Motor Function Classification System (GMFCS) level from baseline to 12 months [Time frame: Baseline and 12 months]
- Change in Manual Ability Classification System (MACS or Mini-MACS) level from baseline to 12 months [Time frame: Baseline and 12 months]
- Incidence of transplantation-related adverse events [Time frame: From intervention through 12 months follow-up]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Vietnam · 1 center
- Vietnam National Children's Hospital — Hanoi
Identifiers
NCT: NCT07527104 · 16/HĐ-K2ĐT · 16/HĐ-K2ĐT