Phase I Safety and Feasibility Study of Intracoronary Delivery of Autologous Bone Marrow Derived Mononuclear Cells
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 13-006427
NCT ID: NCT01708863
Sponsor Protocol Number: 13-006427
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.
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.
- 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
- 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.
Publications are currently not available
Study Results Summary
Not yet available
Supplemental Study Information
Not yet available