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NCT06377982 | Not yet recruiting | Cerebral Palsy


Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy
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

Condition or disease

Cerebral Palsy

Intervention/treatment

hUCB

Phase

Phase 1

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 Type : Interventional
Estimated Enrollment : 12 participants
Masking : Double
Primary Purpose : Treatment
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
Actual Study Start Date : September 2024
Estimated Primary Completion Date : September 2026
Estimated Study Completion Date : December 2026
Arm Intervention/treatment

Experimental: hUCB treatment

Human cord blood infusion

No Intervention: Placebo treatment

Placebo infusion

Ages Eligible for Study: 1 Year to 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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.

Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy

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Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy

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