Cerebral Palsy Hypoxic-Ischemic Encephalopathy Intracranial HemorrhageBMMCT-CPNCT07527104
Autologous Bone Marrow Mononuclear Cell Transplantation Combined With Rehabilitation in Children With Sequelae of Hypoxic-Ischemic Encephalopathy or Intracranial Hemorrhage
A study testing Autologous Bone Marrow Mononuclear Cell Transplantation in people with Cerebral Palsy Hypoxic-Ischemic Encephalopathy Intracranial Hemorrhage, run by National Children's Hospital, Vietnam at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Cerebral Palsy Hypoxic-Ischemic Encephalopathy Intracranial Hemorrhage
- What is being tested?
- Autologous Bone Marrow Mononuclear Cell Transplantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Dec 2025to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Vietnam National Children's Hospital
Hanoi, Hanoi, 111111
DAT HUU DAT, +84-987836686, drtrandat1986@gmail.com
About this study
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
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.
Read the 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.
- Being tested
- Autologous Bone Marrow Mononuclear Cell Transplantation
- Keywords
- Bone Marrow Mononuclear Cells Autologous Transplantation Intrathecal Injection Rehabilitation Pediatric Brain Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Bone Marrow Mononuclear Cell TransplantationProcedure or surgery
Also called Rehabilitation
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.
| Study group | Role | What they receive |
|---|---|---|
| BMMNC Transplantation Plus Rehabilitation | Experimental | Participants receive autologous bone marrow mononuclear cell transplantation via intrathecal administration combined with rehabilitation. Receives: Procedure: Autologous Bone Marrow Mononuclear Cell Transplantation |
| Rehabilitation Alone | No intervention | Participants receive rehabilitation without cell transplantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 12 months
Secondary outcomes (4)
Change in GMFM score at 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.
Measured: Baseline and 3, 6, 9 months
Change in Gross Motor Function Classification System (GMFCS) level from baseline to 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.
Measured: Baseline and 12 months
Change in Manual Ability Classification System (MACS or Mini-MACS) level from baseline to 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.
Measured: Baseline and 12 months
Incidence of transplantation-related adverse events
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.
Measured: From intervention through 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start15 Dec 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy Hypoxic-Ischemic Encephalopathy Intracranial HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Children's Hospital, Vietnam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dat Tran, National Children's Hospital, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527104
- Sponsor's protocol ID
- 16/HĐ-K2ĐT
- Other IDs
- 16/HĐ-K2ĐT
- Acronym
- BMMCT-CP
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in this study will be shared after de-identification. Data will be available beginning 6 months following publication and ending 3 years after publication. Data will be shared with researchers who provide a methodologically sound proposal, for the purpose of achieving aims in the approved proposal. Proposals should be directed to the corresponding investigator. Data access will be provided after approval by the study team and institutional review board.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07527104
- Acronym / sponsor ID
- BMMCT-CP / 16/HĐ-K2ĐT
- Keywords
- Bone Marrow Mononuclear Cells Autologous Transplantation Intrathecal Injection Rehabilitation Pediatric Brain Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Children's Hospital, VietnamUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMMNC Transplantation Plus Rehabilitation | Experimental | Procedure: Autologous Bone Marrow Mononuclear Cell TransplantationParticipants receive autologous bone marrow mononuclear cell transplantation via intrathecal administration combined with rehabilitation. |
| Rehabilitation Alone | No intervention | –Participants receive rehabilitation without cell transplantation. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Bone Marrow Mononuclear Cell TransplantationAlso: RehabilitationAutologous 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. | Procedure or surgery | BMMNC Transplantation Plus Rehabilitation |
Primary outcome
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).
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in this study will be shared after de-identification. Data will be available beginning 6 months following publication and ending 3 years after publication. Data will be shared with researchers who provide a methodologically sound proposal, for the purpose of achieving aims in the approved proposal. Proposals should be directed to the corresponding investigator. Data access will be provided after approval by the study team and institutional review board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Bone Marrow Mononuclear Cell Transplantation in people with Cerebral Palsy Hypoxic-Ischemic Encephalopathy Intracranial Hemorrhage, run by National Children's Hospital, Vietnam at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DAT HUU TRAN (+84987836686, drtrandat1986@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gross Motor Function Measure (GMFM-88) total score from baseline to 12 months (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.