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Safety and Effectiveness of Cord Blood Stem Cell Infusion for the Treatment of Cerebral Palsy in Children

NCT01072370 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2022-10-07

No results posted yet for this study

Summary

The purpose of this study is to test the safety and effectiveness of a cord blood infusion in children who have motor disability due to cerebral palsy (CP). The subjects will be children whose parents have saved their infant's cord blood, who have non-progressive motor disability, and whose parents intend to have a cord blood infusion.

Conditions

  • Cerebral Palsy

Interventions

BIOLOGICAL

Cord Blood Infusion

red-cell depleted, mononuclear cell enriched cord blood unit prepared for infusion

BIOLOGICAL

Intravenous Sham

intravenous infusion of 5% dextrose, ¼ normal saline solution

Sponsors & Collaborators

  • Augusta University

    lead OTHER

Principal Investigators

  • James E Carroll, M.D. · Augusta University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
1 Year
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2019-02-28
Completion
2019-02-28

Countries

  • United States

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 NCT01072370 on ClinicalTrials.gov