NCT06377982
Not yet recruiting
Phase 1
A Phase I, Randomized, Double-blind, Placebo-controlled Clinical Study to Assess the Safety and Efficacy of Allogeneic Human Umbilical Cord Blood Infusion in Children with Cerebral Palsy
StemCyte Taiwan Co., Ltd.0 sites12 target enrollmentSeptember 2025
Overview
- Phase
- Phase 1
- Intervention
- hUCB
- Conditions
- Cerebral Palsy
- Sponsor
- StemCyte Taiwan Co., Ltd.
- Enrollment
- 12
- Primary Endpoint
- safety-TEAE
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
A phase I, randomized, double-blind, placebo-controlled clinical study to assess the safety and efficacy of allogeneic human umbilical cord blood infusion in children with cerebral palsy
Detailed Description
This is a phase I study to evaluate the safety and efficacy in hUCB treatment on the patients with cerebral palsy (CP).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female underage at the time of screening.
- •With a confirmed diagnosis of CP
- •non-progressive motor disability
- •brain dysfunction
Exclusion Criteria
- •Judged by the Investigator to be not suitable/eligible for study participation.
Arms & Interventions
hUCB treatment
Human cord blood infusion
Intervention: hUCB
Outcomes
Primary Outcomes
safety-TEAE
Time Frame: From screening to 56 weeks
Frequency and incidence of treatment-emergent adverse events (TEAEs).
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