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New treatment option for Cerebral Palsy Hypoxic-Ischemic Encephalopathy Intracranial Hemorrhage
Official title Autologous Bone Marrow Mononuclear Cell Transplantation Combined With Rehabilitation in Children With Sequelae of Hypoxic-Ischemic Encephalopathy or Intracranial Hemorrhage
ClinicalTrials.gov ID: NCT07527104
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 18
You may be able to join 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
You likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hanoi, Hanoi, Vietnam
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hanoi, Hanoi, Vietnam. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.