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NCT Number: NCT06377982

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

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hUCB

Biological

hUCB

Primary outcomes

  1. safety-TEAE

    Time frame: From screening to 56 weeks

    Frequency and incidence of treatment-emergent adverse events (TEAEs).

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Chieh Bobo Chen, PhD

CONTACT

[email protected]

02-26013013 Ext809

Sponsors and collaborators

Lead sponsor

StemCyte Taiwan Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 22, 2024
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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