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Allogenic Umbilical Cord Blood and Erythropoietin Combination Therapy for Cerebral Palsy

NCT01193660 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2020-11-24

Study results available
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Summary

This randomized control study is aimed to determine efficacy of umbilical cord blood and erythropoietin combination therapy for children with cerebral palsy.

Conditions

  • Cerebral Palsy

Interventions

BIOLOGICAL

Umbilical Cord Blood Infusion

The subjects will be undertaken allogeneic umbilical cord blood infusion (total nucleated cells \> 3x10\^7/kg) intravenously under non-myeloablative immunosuppression (maintaining blood level of cyclosporine as 100-200ng/mL for 1 month).

DRUG

Erythropoietin Injection

Erythropoietin will be given as the schedule of twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times.

OTHER

Active Rehabilitation

All subjects should participate in active rehabilitation. They received two physical and occupational therapy sessions per day. Post discharge, each participant continued to receive rehabilitation therapy at least 3 days per week for additional 5 months.

OTHER

Placebo Umbilical Cord Blood

Placebo Umbilical Cord Blood will be given except the Experimental arm. Placebo Umbilical Cord Blood was made using peripheral blood. Participants and Investigators maintained as blind.

OTHER

Placebo Erythropoietin

Placebo Erythropoietin containing Normal Saline

Sponsors & Collaborators

  • Sung Kwang Medical Foundation

    lead OTHER

Principal Investigators

  • Minyoung Kim, MD, PhD · CHA University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Months
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01193660 on ClinicalTrials.gov