Actively Recruiting

Phase 2
Age: 1Year - 10Years
All Genders
NCT06629324

Evaluating Bone Marrow Cell Transplant for Treating Cerebral Palsy From Brain Hypoxia

Led by Vinmec Research Institute of Stem Cell and Gene Technology · Updated on 2026-01-22

58

Participants Needed

2

Research Sites

119 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 marrow mononuclear cell (BM MNC) transplantation impact the gross motor function (GMFM-88) scores and Gross Motor Function Classification System (GMFCS) scores in children with cerebral palsy? * How does autologous BM MNC transplantation influence muscle tone (Modified Ashworth Scale score) and hand motor function (MACS/Mini-MACS scale) in children with cerebral palsy, 9 months post the initial transplantation? Fifty-eight selected patients, aged 1 to 10 years and diagnosed with spastic cerebral palsy due to brain hypoxia, will be randomly divided into two groups: * Group A: will receive two BM MNC infusions with the first at baseline and the second at 6 months ± 21 days (T6) via the spinal route. * Group B: will serve as the control group for the first 9 months. During this period, patients will not receive cell transplantation but will undergo a similar rehabilitation and medication regimen as Group A. After 9 months, Group B will receive two BM MNC infusions: the first at 9 months ± 21 days (T9) and the second at 15 months ± 21 days (T15) via the spinal route, with a follow-up at 18 months ± 21 days (T18) compared to baseline. * Both groups: will undergo rehabilitation for 10 days per month, three times, either at rehabilitation centers or performed by a rehabilitation technician at home. After this period, continued training will be conducted by family members. The combined medication regimen will include muscle relaxants (if muscle spasticity is present), vitamins, and neuroprotective drugs (Piracetam).

CONDITIONS

Official Title

Evaluating Bone Marrow Cell Transplant for Treating Cerebral Palsy From Brain Hypoxia

Who Can Participate

Age: 1Year - 10Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age from 1 to 10 years, both genders
  • Gross Motor Function Classification System (GMFCS) levels II to V
  • Spastic cerebral palsy caused by brain hypoxia
Not Eligible

You will not qualify if you...

  • Coagulation disorders
  • Severe health conditions such as cachexia, heart failure, lung, liver, or kidney failure, or active infections
  • Spinal injuries preventing catheter placement through the spinal cavity
  • Cancer
  • HIV positive or active viral hepatitis
  • Hemoglobin below 110 g/L

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Vinmec research Institute and Gene Technology

Hanoi, Vietnam, 100000

Actively Recruiting

2

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, Vietnam, 100000

Not Yet Recruiting

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Research Team

L

Liem T Nguyen, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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