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NCT06377982 Clinical Trial

Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:
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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06377982
Other study ID # SCCP001
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date September 2024
Est. completion date December 2026

Study information
Verified date April 2024
Source StemCyte International, Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Description:

This is a phase I study to evaluate the safety and efficacy in hUCB treatment on the patients with cerebral palsy (CP).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 12
Est. completion date December 2026
Est. primary completion date September 2026
Accepts healthy volunteers No
Gender All
Age group 1 Year to 18 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• hUCB
hUCB

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
StemCyte Taiwan Co., Ltd.

Outcome
Type Measure Description Time frame Safety issue
Primary safety-TEAE Frequency and incidence of treatment-emergent adverse events (TEAEs). From screening to 56 weeks
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