Autologous bone marrow cell transplant for spastic cerebral palsy from brain hypoxia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II randomized trial will enroll 58 children aged 1–10 with spastic cerebral palsy due to brain hypoxia and GMFCS levels II–V at Vinmec in Hanoi. Participants will be randomly assigned to receive autologous bone marrow mononuclear cell transplantation plus rehabilitation or a control regimen, with treatments delivered per protocol and follow-up visits over nine months after the first transplantation. Safety outcomes include monitoring adverse events and serious adverse events, and efficacy outcomes include changes in GMFM-88, GMFCS, Modified Ashworth Scale, and MACS/Mini-MACS scores. The trial builds on a Phase I safety study and aims to quantify functional gains and tone changes under standardized rehabilitation.

Why it matters

Who can join: the full rules

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 kidney failure; or active infections;
* Spinal injuries prevent the placement of a catheter through the spinal cavity;
* Cancer;
* HIV positive, active viral hepatitis;
* Hemoglobin below 110 g/L.

Where it's running

• Vinmec research Institute and Gene Technology
  Hanoi, Vietnam Recruiting
• Vinmec Research Institute of Stem Cell and Gene Technology
  Hanoi, Vietnam Not yet recruiting

Study contacts

• Principal investigator: Liem T Nguyen, MD., PhD — Vinmec Research Insitute of Stem Cell and Gene Technology
• Study coordinator: Liem T Nguyen, MD, PhD
• Email: v.liemnt@vinmec.com
• Phone: 800-555-5555

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.