Cerebral Palsy
Conditions
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).
Interventions
BIOLOGICALhUCB
hUCB
Sponsors
StemCyte Taiwan Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety-TEAE | From screening to 56 weeks | Frequency and incidence of treatment-emergent adverse events (TEAEs). |
Contacts
Primary ContactYing Chieh Bobo Chen, PhD
Outcome results
None listed