Human Umbilical Cord Blood Infusion in Patients with Cerebral Palsy

NCT ID: NCT06377982

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2028-12-31

Brief Summary

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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

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

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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hUCB treatment

Human cord blood infusion

Group Type EXPERIMENTAL

hUCB

Intervention Type BIOLOGICAL

hUCB

Placebo treatment

Placebo infusion

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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hUCB

hUCB

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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StemCyte Taiwan Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Ying Chieh Bobo Chen, PhD

Role: CONTACT

02-26013013 Ext809

Other Identifiers

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SCCP001

Identifier Type: -

Identifier Source: org_study_id

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