A Study to Analyze Intramyocardial Injection Mononuclear Cells during Fontan Surgical Palliation of Congenital Heart Disease


About this study

This study aims to evaluate the safety of intramyocardial delivery of autologous umbilical cord blood-derived mononuclear cells during Fontan surgical palliation and measure surrogate markers of myocardial protection within a non-randomized study design to obtain prospective data from treatment and control populations.

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:

  • Diagnosis of a congenital heart defect with functionally single right ventricle (such as HLHS, HLHS variants, unbalanced AV septal defect with RV dominance, DORV with Hypoplastic LV) undergoing Fontan surgical palliation.
  • At least 2 and less than or equal to 5 years of age at time of Fontan surgical palliation.
  • For subjects enrolling in the treatment arm, previous participation in clinical trial Umbilical Cord Blood Collection and Processing for Hypoplastic Left Heart Syndrome Patients (NCT01856049) with autologous UCB-MNC product collected and available for distribution is required.

Exclusion Criteria:

  • History of DMSO reaction (treatment arm only subjects).
  • Parent(s) or legal guardian unwilling to have their child participate or unwilling to follow the study procedures.
  • Severe chronic diseases at the discretion of the treating physician.
  • Extensive extra-cardiac syndromic features.
  • History of cancer.
  • Any of the following complications of his/her congenital heart disease:
    • Any condition requiring urgent, or unplanned interventional procedure within 15 days prior to Fontan surgical palliation, unless complete and full cardiac recovery is documented by site investigator.
    • Severe pulmonary hypertension (reported in the medical record as >70% systemic pressure).
    • Other clinical concerns as documented by a site investigator that would predict (more likely to happen than not to happen) a risk of severe complications or very poor outcome, not directly related to the stem cell product or its injection procedure, during or after Fontan surgical palliation.
  • Individuals with severe heart failure that requires heart transplantation.
  • Individuals with refractory or worsening arrhythmia.
  • Individuals with an automated implantable cardioverter defibrillator (AICD) or pacemaker.
  • Patients with prior surgical complications during the Fontan surgical palliation that resulted in or could be reasonably expected to significantly decrease cardiac function.

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

Joseph Dearani, M.D.

Closed for enrollment

Contact information:

Karen Miller CCRP

(507) 266-5510


More information


Publications are currently not available

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