A Study to Validate Bioengineered Cardiac Tissue in Post-Fontan Surgery Patients

Overview

About this study

The purposes of this study are to generate fibroblast cell lines from dermal punch biopsies obtained from participating subjects and to derive induced Pluripotent Stem Cells-Cardiac Lineage (iPSC-CL) cells from fibroblasts to support product/process development.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Adults ≥ 18 years of age.
Post-Fontan palliative surgery and who currently have heart failure, or are at a high risk for heart failure post Fontan surgery.
Patients with post-Fontan palliative surgery status, heart failure and able to provide informed consent.

Exclusion Criteria:

Individuals < 18 years of age.
Inability to speak English.
Inability or unwilling to provide informed consent.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Timothy Nelson, M.D., Ph.D.	Closed for enrollment	Contact information: Lori Riess CCRP (507) 538-7730 riess.lori@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Timothy Nelson, M.D., Ph.D.

Closed for enrollment

Contact information:

Lori Riess CCRP

(507) 538-7730

riess.lori@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials