Human Umbilical Cord Blood Infusion in Patients with Cerebral Palsy

StemCyte International, Ltd.

Status and phase: Begins enrollment in 7 months; Phase 1

Conditions: Cerebral Palsy

Treatments: Biological: hUCB

Study type: Interventional

Funder types: Industry

Identifiers

NCT06377982

SCCP001

Details and patient eligibility

About

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

Full description

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

Enrollment: 12 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 2 patient groups

hUCB treatment

Experimental group

Description:

Human cord blood infusion

Treatment:

Biological: hUCB

Placebo treatment

No Intervention group

Description:

Placebo infusion