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.
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.
Eligibility
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
