Phase I Safety and Feasibility Study of Intracoronary Delivery of Autologous Bone Marrow Derived Mononuclear Cells

Overview

About this study

The objective of this study is to determine the safety and feasibility of autologous mononuclear cells (MNC) collected from bone marrow (BM) and intracoronary delivery for individuals with declining ventricle systemic pumps. This procedure has the potential to foster a new strategy for congenital heart patients. This is an open-label study of autologous MNC derived from bone marrow with a 2-year follow-up to document 1) related serious adverse events and 2) monitor changes in cardiac structure and function.

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:

Individuals with Fontan circulation with right ventricular dysfunction
Ejection fraction equal to or less than 40% despite optimal outpatient medical management for at least 3 months
Able to undergo bone marrow aspirate according to clinical consultation with hematology (INR must be maintained at or below 1.5)
Able to undergo an MRI or CT examination

Exclusion Criteria:

Individuals or parents of minors unwilling to consent to participation
Individuals with severe chronic diseases, extra-cardiac syndromes, or cancer
Females 10 years and older with positive pregnancy test or lack of effective birth control method
Individuals currently requiring IV inotropes
Individuals with bleeding disorders or history of thrombosis
Individuals not eligible for MRI and have elevated serum creatinine level (eGFR less that 45 mL/min) and therefore cannot have a CT examination
Individuals not eligible for MRI and have a prior significant reaction to intravenous contrast required for CT examination
Individuals with the following conditions within 60 days prior to procedure:
- Cardiogenic shock or extracorporeal circulation;
- New arrhythmia that required medication for control;
- Documented infection requiring treatment with antibiotics, and/or current infection being treated with antibiotics;
- Cardiac condition requiring emergency procedure;
- Cardiovascular surgery;
- Seizures or history of significant neurological injury;
- Multi-system organ failure including acute or chronic renal failure

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
Rochester, Minn. Mayo Clinic principal investigator Muhammad Qureshi, M.B.B.S.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Muhammad Qureshi, M.B.B.S.

Closed for enrollment

More information

Publications

Publications are currently not available

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