Vietnam National Children's Hospital
Hanoi, 111111, Vietnam
Location status: Recruiting
Recruiting
NCT Number: NCT07527104
Autologous Bone Marrow Mononuclear Cell Transplantation Combined With Rehabilitation in Children With Sequelae of Hypoxic-Ischemic Encephalopathy or Intracranial Hemorrhage
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
6 month–18 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Autologous Bone Marrow Mononuclear Cell Transplantation
ProcedureAutologous 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.
Other names: Rehabilitation
Primary outcomes
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Change in Gross Motor Function Measure (GMFM-88) total score from baseline to 12 months
Time frame: Baseline and 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).
Secondary outcomes
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Change in GMFM score at 3, 6, 9 months
Time frame: Baseline and 3, 6, 9 months
Gross motor function will be assessed using the Gross Motor Function Measure (GMFM-88), a standardized clinical tool for children with cerebral palsy and related neurological impairment. The change in GMFM-88 total score from baseline to 3, 6,9 months will be calculated and compared between the intervention and control groups.
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Change in Gross Motor Function Classification System (GMFCS) level from baseline to 12 months
Time frame: Baseline and 12 months
Gross motor function classification will be assessed using the Gross Motor Function Classification System (GMFCS), which categorizes motor function based on self-initiated movement abilities, particularly sitting and mobility. Changes in GMFCS level from baseline to 12 months will be evaluated and compared between the intervention and control groups.
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Change in Manual Ability Classification System (MACS or Mini-MACS) level from baseline to 12 months
Time frame: Baseline and 12 months
Manual ability will be assessed using the Manual Ability Classification System (MACS) or Mini-MACS depending on the child's age. Changes in manual ability level from baseline to 12 months will be evaluated and compared between the intervention and control groups.
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Incidence of transplantation-related adverse events
Time frame: From intervention through 12 months follow-up
Adverse events related to bone marrow aspiration, anesthesia, intrathecal transplantation, and follow-up will be recorded. These include local pain at the aspiration site, low back pain after transplantation, fever, irritability, vomiting, rash, and other procedure-related complications. The incidence and severity of adverse events will be monitored and summarized throughout the study.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
National Children's Hospital, Vietnam
Other
Registry information
Official study 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
Acronym: BMMCT-CP
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Apr 14, 2026
- Registry last updated
- Apr 14, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.