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).

Study Timeline

• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-17
• Study First Posted: 2024-04-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Study Start: 2025-09
• Primary Completion: 2027-09
• Study Completion: 2028-12

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).