This trial is terminated!
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More info
You can access this
clinical trial
if you have
Hypoplastic Left Heart Syndrome
and you are
under 2
years old
1
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

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.

Provided treatments

  • Biological: Autologous Umbilical Cord Blood
  • Biological: Autologous Umbilical Cord Blood

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01445041. The sponsor of the trial is Michael Cotten and it is looking for 7 volunteers for the current phase.
Official trial title:
Autologous Cord Blood Cells for Patients With HLHS: Phase I Study of Feasibility and Safety