Adult Stem Cells
Adult Stem Cells

CLINICAL TRIAL

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

PURPOSE

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.

OFFICIAL TITLE

A Placebo-Controlled, Observer-Blinded, Crossover Study to Evaluate the Safety and Effectiveness of a Single, Autologous, Cord Blood Stem Cell Infusion for the Treatment of Cerebral Palsy in Children (Clinical Trial Identifier: NCT01072370)

STUDY DESIGN & DATES

Phase I & II, Randomized, Double-Blind
Study Start Date: Jan 2010
Estimated Study Completion Date: Feb 2014
Estimated Primary Completion Date: Feb 2013 (Final data collection date for primary outcome measure)

CONTACTS

Kimberly R Gray, BBA, CCRP
Phone: 706-721-3600
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

LOCATIONS

United States:  

Georgia Health Sciences University
Augusta, Georgia, United States, 30912

INVESTIGATORS

Principal Investigator: James E Carroll, M.D (706-721-3371 or  This email address is being protected from spambots. You need JavaScript enabled to view it. )

ELIGIBILITY: INCLUSION CRITERIA

Must be more than 1 year of age and less than 12 years of age at the time of screening for inclusion in the study.

Clinical evidence of a non-progressive motor disability due to brain dysfunction. The subjects will not have the ability to sit independently by one year of age or the ability to walk by 18 months of age.

Have stored umbilical cord blood with CBR that meets all selection and testing criteria

Willing to comply with all study procedures

The nucleated cells available in the cord blood sample stored at CBR must exceed 1 X 107 cells per kg body weight. (Note: Because cord blood collection has been in process for about 16 years but widely for far less than that period, the age of most subjects likely will be considerably less than 12 years of age. Due to the amount due of cord blood available for most subjects, the body weight of subjects usually will not exceed 25 kg).

The patients must be seizure-free or seizures adequately controlled. If there is a suspicion of seizures and EEG should be done prior to inclusion.

ELIGIBILITY: EXCLUSION CRITERIA

Complicating medical issues that would interfere with blood drawing, such as venous access so limited that success is unlikely

Presence of obstructive hydrocephalus

Presence of progressive neurological disease

Presence of significant defect of brain development, such as schizencephaly or agenesis of corpus callosum

Presence of known chromosomal anomaly

Presence of major congenital anomaly

Severe intrauterine growth restriction (birth weight less than 1800 grams)

Cord blood viability <60%

Positive infectious disease markers from mother's blood or cord blood at the time of collection

Evidence of illness on planned infusion date (such as but not limited to fever >38.5, vomiting, diarrhea, wheezing, or crackles)

Pregnancy

Use of immunosuppressive drugs

Evidence of known genetic disorder

Impaired hepatic or renal function

CLICK FOR FULL TRIAL ENTRY on CLINICALTRIAL.GOV

All information is © 2014 by the Cell Therapy Foundation
Adult Stem Cells
This email address is being protected from spambots. You need JavaScript enabled to view it.

* Designates sites with available clinical trials.