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

NCT07527104 | Recruiting DMC

• 1 other identifier: 16/HĐ-K2ĐT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy Hypoxic-Ischemic Encephalopathy Intracranial Hemorrhage

Keywords

Bone Marrow Mononuclear Cells Autologous Transplantation Intrathecal Injection Rehabilitation Pediatric Brain Injury

Outcome Measures

Primary Outcomes (1)

• Change in Gross Motor Function Measure (GMFM-88) total score from baseline to 12 months

  Gross motor function will be assessed using the Gross Motor Function Measure (GMFM-88), a validated and standardized clinical scale for evaluating motor function in children with neurological impairment. The primary outcome is the change in GMFM-88 total score from baseline to 12 months. The change in score will be calculated and compared between the intervention group (autologous bone marrow mononuclear cell transplantation plus rehabilitation) and the control group (rehabilitation alone).

  Baseline and 12 months

Secondary Outcomes (4)

• Change in GMFM score at 3, 6, 9 months

  Baseline and 3, 6, 9 months

• Change in Gross Motor Function Classification System (GMFCS) level from baseline to 12 months

  Baseline and 12 months

• Change in Manual Ability Classification System (MACS or Mini-MACS) level from baseline to 12 months

  Baseline and 12 months

• Incidence of transplantation-related adverse events

  From intervention through 12 months follow-up

Study Arms (2)

BMMNC Transplantation Plus Rehabilitation

EXPERIMENTAL

Participants receive autologous bone marrow mononuclear cell transplantation via intrathecal administration combined with rehabilitation.

Procedure: Autologous Bone Marrow Mononuclear Cell Transplantation

Rehabilitation Alone

NO INTERVENTION

Participants receive rehabilitation without cell transplantation.

Interventions

Autologous Bone Marrow Mononuclear Cell Transplantation PROCEDURE

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.

Also known as: Rehabilitation

BMMNC Transplantation Plus Rehabilitation

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Children's Hospital, Vietnam: lead

Study Sites (1)

Vietnam National Children's Hospital

Hanoi, Hanoi, 111111, Vietnam

RECRUITING

Related Links

• Related Info

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

DAT HUU TRAN

CONTACT

+84987836686; drtrandat1986@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 14, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available beginning 6 months following publication of the primary results and ending 3 years after publication.
• Access Criteria: Access to de-identified individual participant data and supporting documents will be provided to qualified researchers who submit a methodologically sound proposal. Proposals should be directed to the corresponding investigator. Data access will be granted following review and approval by the study team and the institutional review board. A data use agreement may be required.

Locations

VN (1)