Human Umbilical Cord Blood Infusion in Patients with Cerebral Palsy
Phase 1
Not yet recruiting
- Conditions
- Cerebral Palsy
- Interventions
- Biological: hUCB
- Registration Number
- NCT06377982
- Lead Sponsor
- StemCyte Taiwan Co., Ltd.
- 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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 12
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description hUCB treatment hUCB Human cord blood infusion
- Primary Outcome Measures
Name Time Method safety-TEAE From screening to 56 weeks Frequency and incidence of treatment-emergent adverse events (TEAEs).
- Secondary Outcome Measures
Name Time Method