CLINICAL TRIALS

Research volunteers play a key role in enabling researchers in the Todd and Karen Wanek Family Program for HLHS at Mayo Clinic, HLHS Consortium, and HeartWorks to reach their goal of finding solutions for individuals with HLHS and CHD.

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Umbilical cord blood collection

By collecting and banking your baby's umbilical cord blood with the Todd and Karen Wanek Family Program for HLHS at Mayo Clinic, you make it possible for your child to participate in future clinical trials using stems cells from your baby's own body. The goal of the clinical trials is to strengthen the heart using stem cells.

When umbilical cord blood is collected through the Todd and Karen Wanek Family Program for HLHS, it is processed with the goal of using the isolated stem cells in current or future clinical trials. Umbilical cord blood can be collected at any hospital in the United States and shipped to the HLHS program to be banked.

Contact the Todd and Karen Wanek Family Program for HLHS at HLHS@mayo.edu today to learn more or to receive your free collection kit.

Phase II umbilical cord blood clinical trial

The phase II clinical trial on umbilical cord blood is to determine if stem cells from an individual's own umbilical cord blood can be used to strengthen the right side of their heart. The study is based on the successful results of a Phase I study, and will help determine the efficacy and safety of using cell-based regenerative therapy as an additional treatment for the management of HLHS.

This study also includes a control arm for infants with HLHS who do not receive the stem cell treatment. Babies can be enrolled any time before the second stage (Glenn) surgery is scheduled, even if their stem cells were not collected.

To participate in the stem cell delivery part of this clinical trial, your baby's umbilical cord blood must be stored with the Todd and Karen Wanek Family Program for HLHS at Mayo Clinic, which can be done at no charge to you.

Genetic investigations

The goal of the Todd and Karen Wanek Family Program for HLHS' genetics clinical trial is to utilize comprehensive, family-centered genomic screening strategies — chromosomal microarray and whole-genome sequencing — to discover the genetic bases for HLHS.

Bone marrow clinical trial

The goal of the program's bone marrow clinical trial is to determine if stem cells from an individual's own bone marrow can be used to strengthen the right side of their heart. This clinical trial will help determine the safety and feasibility of using cell-based regenerative therapy for individuals with declining single right ventricles.