Umbilical Cord Blood Therapy for Cerebral Palsy

MinYoung Kim, M.D.

Status and phase: Completed; Phase 2

Conditions: Cerebral Palsy

Treatments: Other: Placebo Umbilical Cord Blood; Biological: Umbilical Cord Blood Infusion; Other: Active Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT01528436

CPUCBRCT

Details and patient eligibility

About

This randomized controlled study aims to evaluate the efficacy of umbilical cord blood therapy for children with cerebral palsy.

Full description

Cerebral palsy is a disorder of movement and posture resulted from a non-progressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability.

Many experimental animal studies have revealed that umbilical cord blood is useful to repair neurological injury in brain.

On the basis of many experimental studies, umbilical cord blood is suggested as a potential therapy for cerebral palsy.

Enrollment: 37 patients

Sex: All

Ages: 6 months to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cerebral Palsy with abnormal muscle tone
• Gross Motor Function Classification System (GMFCS): I, II, III, IV, V
• Willing to comply with all study procedure

Exclusion criteria

• Medical instability including pneumonia or renal function at enrollment
• Presence of known genetic disease
• Presence of drug hypersensitivity which is related to this study remedy
• Poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up
• Decision by the principal investigator when there are unexpected events including brain surgery, that may affect the outcome

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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37 participants in 2 patient groups

Umbilical Cord Blood and Rehabilitation

Experimental group

Description:

Allogeneic Umbilical Cord Blood infusion and Active Rehabilitation

Treatment:

Other: Active Rehabilitation

Biological: Umbilical Cord Blood Infusion

Placebo Umbilical Cord Blood and Rehabilitation

Active Comparator group

Description:

Placebo Umbilical Cord Blood infusion and Active Rehabilitation

Treatment:

Other: Active Rehabilitation

Other: Placebo Umbilical Cord Blood