Umbilical Cord Blood Therapy for Cerebral Palsy

M

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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