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Safety and Feasibility Study of Umbilical Cord Blood Cells for Infants With Hypoplastic Left Heart Syndrome
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 hypoplastic left heart syndrome (HLHS). Study Rationale and Hypotheses: The major goal of this study is to determine whether infusion of autologous UCB cells in neonates with hypoplastic left heart syndrome is feasible and safe. The rationale for the study and for the potential benefit of UCB is based upon the following hypotheses: 1. Infants with HLHS have significant neural injury evidenced from both prenatal and early antenatal brain MRI findings and infusion of UCB cells may lessen neural injury. Although the exact mechanism is unknown, UCB cell infusion may ameliorate neural injury via paracrine and anti-inflammatory effects that enhance post injury repair and may promote endogenous functional compensation of other cortical areas resulting in significant clinical improvements. 2. UCB cells may also enhance cardiac function, minimize scar formation, and reverse detrimental remodeling after cardiac injury.
Details
| Lead sponsor | Michael Cotten |
|---|---|
| Phase | PHASE1 |
| Status | TERMINATED |
| Enrolment | 7 |
| Start date | Thu Sep 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Fri Apr 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Hypoplastic Left Heart Syndrome
Interventions
- Autologous Umbilical Cord Blood
- Autologous Umbilical Cord Blood
Countries
United States