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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorNational Children's Hospital, Vietnam

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Autologous Bone Marrow Mononuclear Cell Transplantation

Treatment groups

60 Participants
are divided into 2 treatment groups