Human Umbilical Cord Blood Infusion in Patients with Cerebral Palsy
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
1 other identifier
interventional
12
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2025
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2024
CompletedFirst Posted
Study publicly available on registry
April 22, 2024
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
February 27, 2025
February 1, 2025
2 years
April 17, 2024
February 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
safety-TEAE
Frequency and incidence of treatment-emergent adverse events (TEAEs).
From screening to 56 weeks
Study Arms (2)
hUCB treatment
EXPERIMENTALHuman cord blood infusion
Placebo treatment
NO INTERVENTIONPlacebo infusion
Interventions
Eligibility Criteria
You may qualify if:
- Male or female underage at the time of screening.
- With a confirmed diagnosis of CP
- non-progressive motor disability
- brain dysfunction
You may not qualify if:
- Judged by the Investigator to be not suitable/eligible for study participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2024
First Posted
April 22, 2024
Study Start
September 1, 2025
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
December 1, 2028
Last Updated
February 27, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share