Evaluating Bone Marrow Cell Transplant for Treating Cerebral Palsy From Brain Hypoxia
Recruiting
Phase 2
Interventional Study
Autism Spectrum Disorder
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 – 10
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 58 (estimated)
- Sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology · Other
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About This Trial
This clinical trial aims to evaluate the effectiveness of autologous bone marrow mononuclear cell transfusion in treating cerebral palsy caused by cerebral hypoxia.
The key questions the study seeks to answer are:
* What is the safety profile in terms of adverse events (AE) and serious adverse events (SAE) observed over the 9 months following the first transplantation?
* How does autologous bone…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age from 1 to 10 years, both genders;
* Gross Motor Function Classification System (GMFCS): levels II to V;
* Spastic cerebral palsy due to brain hypoxia.
Exclusion Criteria:
* Coagulation disorders;
* Severe health conditions such as cachexia, heart failure, lung, liver, or…
Contacts