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FLT-PET Activity Change After Allogeneic Umbilical Cord Blood (UCB) Therapy in Cerebral Palsy

NCT01486732 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2013-11-19

No results posted yet for this study

Summary

This is randomized placebo-controlled trial to recognize new cell regeneration in the brain using FLT-PET.

Conditions

  • Cerebral Palsy

Interventions

BIOLOGICAL

Umbilical Cord Blood Infusion

The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.

OTHER

Active Rehabilitation

All subjects should participate in active rehabilitation. They will receive 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 2.5 months.

OTHER

Placebo Umbilical Cord Blood

Placebo Umbilical Cord Blood that resembles cord blood in appearance was designed : 1.5 to 3 ml of the subject's own blood was collected and mixed with 15 to 20 ml of albumin

Sponsors & Collaborators

  • Bundang CHA Hospital

    lead OTHER

Principal Investigators

  • Minyoung Kim, M.D., Ph.D. · CHA University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-04-30
Completion
2014-07-31

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 NCT01486732 on ClinicalTrials.gov