- Infants diagnosed with hypoplastic left heart syndrome in utero
- Stem cell collection at birth; Glenn procedure at 3-6 months old
- COMIRB number
- Reimbursement for some travel costs
Phase I Safety Study of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Stage II Palliation of Hypoplastic Left Heart Syndrome
Physician researchers at Children’s Hospital Colorado want to learn more about using regenerative medicine (stem cells) as a possible treatment option for a rare congenital heart defect called hypoplastic left heart syndrome (HLHS).
Purpose of the study
The goal of this study is to determine the safety and feasibility of delivering a child’s own stem cells into their heart muscle during a specific type of heart surgery called the Glenn procedure. The Glenn procedure is one of three heart surgeries performed on children born with HLHS.
In order to qualify for this study, patients must have participated in Mayo Clinic’s umbilical cord blood collection protocol, which is separate from the current study. Stem cells collected from the cord blood will be delivered into the right side of their heart during the Glenn surgery procedure, at approximately 3 to 6 months of age. Study participants will be monitored to determine the viability and safety of using regenerative therapy to treat HLHS.
This study is a partnership between Children’s Colorado and the Todd and Karen Wanek Family Program for Hypoplastic Left Heart Syndrome at Mayo Clinic.
For questions about this study, please contact local principal investigator, James Jaggers, MD:
Learn more about the Heart Institute and the Colorado Fetal Care Center at Children’s Colorado.