Status:
TERMINATED
Safety and Feasibility Study of Umbilical Cord Blood Cells for Infants With Hypoplastic Left Heart Syndrome
Lead Sponsor:
Michael Cotten
Conditions:
Hypoplastic Left Heart Syndrome
Eligibility:
All Genders
Up to 2 years
Phase:
PHASE1
Brief Summary
Further study details as provided by Duke University: Purpose: To evaluate the feasibility and safety of collecting and infusing autologous umbilical cord blood (UCB) in newborn infants with hypoplas...
Detailed Description
The purpose of this pilot study is to evaluate the safety and feasibility of infusions of autologous (the patient's own)umbilical cord blood cells in neonates with hypoplastic left heart syndrome. Thi...
Eligibility Criteria
Inclusion
- Infants \> 35 weeks gestational age.
- Diagnosis: Hypoplastic Left Heart Syndrome.
- Autologous umbilical cord blood available with a minimum total nucleated cell dose of 1 x 10e7 cells/kg.
- Parental Consent.
Exclusion
- Chromosomal anomalies identified before the time of infusion.
- Chromosomal anomalies or congenital anomalies that would prohibit clinicians from initiating surgical repair of the congenital heart defect.
- Infant is determined by clinical staff to be non-viable and will not receive aggressive care. (No member on the study team will be involved in determining the viability of the neonate.)
- Autologous umbilical cord blood unit has any of the following:
- Total nuclear cell count \< 1 x 10e7.
- Positive maternal infectious serology (except CMV).
- Evidence of infectious contamination of the cord blood unit.
- Evidence of genetic disease.
- Unable to obtain parental consent.
- Mother \< 18 years old.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2016
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01445041
Start Date
September 1 2011
End Date
April 15 2016
Last Update
May 16 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke University
Durham, North Carolina, United States, 27710