Intramyocardial Injection of Autologous UCB-MNC During Fontan Surgery for SRV Dependent CHD (NCT04907526) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Intramyocardial Injection of Autologous UCB-MNC During Fontan Surgery for SRV Dependent CHD
United States30 participantsStarted 2021-06-01
Plain-language summary
Researchers want to better understand what happens to the heart when the autologous (from one's own body) stem cells are injected directly into muscle of the right side of the heart during the Fontan (Stage III) surgery. They want to see if there are changes in the electrical activity, the structure, and the function of the heart following this stem cell-based therapy. Researchers will compare the results from people who receive the stem cells to the results from people who do not receive the stem cells.
Who can participate
Age range2 Years – 5 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of a congenital hear defect with functionally single right ventricle (such as HLHS, HLHS variants, unbalanced AV septal defect with R 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 intervention 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, …