Evaluation of the Efficacy of Autologous Bone Marrow-Derived Mononuclear Cell Transplantation in the Treatment of Cerebral Palsy Due to Brain Hypoxia: A Phase II Randomized Clinical Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 10
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Viet Nam
Vinmec research Institute and Gene Technology
RECRUITING
Hanoi
Vinmec Research Institute of Stem Cell and Gene Technology
NOT_YET_RECRUITING
Hanoi
Contact Information
Primary
Liem T Nguyen, MD, PhD
v.liemnt@vinmec.com
800-555-5555
Time Frame
Start Date: 2024-10-15
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 58
Treatments
Active_comparator: BM MNC transplantation and Rehabilitation
Patients in group A will receive two autologous BM MNC administrations at baseline and 6 months ± 21 days (T6)
Placebo_comparator: Placebo with Rehabilitation, then BM MNC transplantation
Group B will receive BM MNCs at 9 months ± 21 days (T9) and 15 months ± 21 days (T15), with outcomes evaluated at 18 months ± 21 days (T18) compared to baseline.
Sponsors
Leads: Vinmec Research Institute of Stem Cell and Gene Technology

This content was sourced from clinicaltrials.gov