To Assess Safety and Efficacy of Myoblast Implantation Into Myocardium Post Myocardial Infarction
MARVEL
A Multicenter Study to Assess the Safety and Cardiovascular Effects of Myocell™ Implantation by a Catheter Delivery System in Congestive Heart Failure Patients Post Myocardial Infarction(s)
1 other identifier
interventional
170
1 country
33
Brief Summary
This study injects a person's own stem cells into heart muscle tissue after a person has one or more heart attacks. The purpose of the study is whether the stem cells will improve a patient's heart performance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 6, 2007
CompletedFirst Posted
Study publicly available on registry
September 10, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedJuly 21, 2017
July 1, 2017
11.4 years
September 6, 2007
July 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
6-minute walk test
6 months
Quality of Life Questionnaire
6 months
Secondary Outcomes (1)
Hospitalization occurrences
12 months
Study Arms (3)
Low Dose
ACTIVE COMPARATORPatient will undergo biopsy. Skeletal myoblasts will be cultured in growth media.
High Dose
ACTIVE COMPARATORPatient will undergo biopsy. Skeletal myoblasts will be cultured in growth media.
Control
PLACEBO COMPARATORPatient will undergo biopsy of muscle tissue and biopsy tissue will be sent to lab.
Interventions
Patient will receive injections of cultured, expanded skeletal myoblasts into the myocardium at a dose of 400 million cells.
After the cell culture period of time has passed, patient's myocardium will be injected with the transport media alone. Patient will not receive any cultured myoblasts during these injections.
Eligibility Criteria
You may qualify if:
- Chronic CHF, New York Heart Association (NYHA) Class II-IV;
- Stable and on optimal medical management for greater or equal to 60 days as follows:
- systolic and diastolic hypertension controlled in accordance with contemporary guidelines;
- patient stabilized on maximum tolerated dose of beta blockers;
- patient stabilized on maximum tolerated dose of angiotensin concerting enzyme (ACE) inhibitors;
- patients intolerant of ACE inhibitors should be stabilized on angiotensin receptor blockers (ARB);
- fluid control with diuretics and a salt restricted diet;
- patients with sever symptoms of heart failure (Class III-IV) lacking contraindications to aldosterone antagonism and not on both ACE inhibitors and ARBs have been considered for such therapy.
- Age 18-80;
- Left ventricular ejection fraction (LVEF) at screening of less than or equal to 35 percent by multiple gaited acquisition scan (MUGA);
- Need or feasibility for revascularization has been ruled out by previous coronary angiogram or ruled out to the satisfaction of the investigator via previous conventional stress study completed within 1 year of screening. The need or feasibility for revascularization will be reassessed at screening using dobutamine stress echocardiography (DSE);
- Defined region of mycardial dysfunction related to previous MI involving the anterior, later, posterior or inferior walls including the apical septum (excluding the basal septum) assessed by a large area of akinesia in the left ventricle (using DSE at screening);
- B-type natriuretic peptide (BNP) or NT pro-BNP is above the upper limit of normal.
You may not qualify if:
- Non-pregnant women who are not postmenopausal, surgically sterile or not practicing an acceptable method of contraception. A female patient of child bearing potential, with a positive serum or urine pregnancy test at screening visit #1. Females refusing to exercise a reliable form of contraception;
- Myocardial wall thickness of \<6 mm (millimeters) in the akinetic myocardial region to be injected (using DSE at screening)
- Inability to undergo a surgical biopsy of the skeletal muscle for culture of myoblasts, including any significant myopathy;
- Patient will require revascularization within six months;
- Patients on continuous or intermittent intravenous drug therapy;
- Not fitted, or fitted within less than 90 days prior to screening visit #1, with an implantable cardioverter defibrillator (ICD);
- Sustained ventricular tachycardia (VT), automatic implantable cardiodefibrillator (AICD) firing, or ventricular fibrillation (VF) within 90 days prior to screening visit #1;
- Inability to perform a 6 minute walk test due to physical limitations other than HF including:
- Severe peripheral vascular disease, including aortic aneurysms, leading to limited claudication;
- Severe pulmonary disease or chronic obstructive pulmonary disease (COPD) limiting exercise, dependence on chronic oral steroid therapy or previously requiring mechanical ventilation;
- Stroke or transient ischemic attack leading to limitations in lower extremities or occurring within 180 days prior to screening visit #1;
- MI, unstable angina or percutaneous coronary intervention (PCI) within 90 days prior to screening;
- having undergone CABG surgery within 150 days prior to screening visit #1;
- Active myocarditis, constrictive pericarditis, restrictive, hypertrophic or congenital cardiomyopathy;
- Hemodynamically significant severe primary valvular heart disease, unless corrected by a properly functional prosthetic valve;
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bioheart, Inc.lead
Study Sites (33)
Cardiology, P.C.
Birmingham, Alabama, 35211, United States
University of Alabama
Birmingham, Alabama, 35294, United States
Mercy Gilbert Medical Center
Gilbert, Arizona, 85297, United States
Arizona Heart Institute
Phoenix, Arizona, 85006, United States
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Scripps Green Hospital
La Jolla, California, 92037, United States
UCSD Medical Center
La Jolla, California, 92103, United States
Jim Moran Heart and Vascular Research Institute
Fort Lauderdale, Florida, 33317, United States
University of Florida
Gainesville, Florida, 32610, United States
University of Florida Shands
Jacksonville, Florida, 32209, United States
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
Florida Hospital Center Cardiovascular Center
Orlando, Florida, 32803, United States
Emory/Crawford Long
Atlanta, Georgia, 30308, United States
St. Joseph's Research Institute/ACRI
Atlanta, Georgia, 30342, United States
RUSH University Medical Center
Chicago, Illinois, 60612, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
Our Lady of Lourdes Medical Center
Camden, New Jersey, 08103, United States
Gagnon Heart Hospital
Morristown, New Jersey, 07962, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Columbia University Medical Center
New York, New York, 10032, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
The Lindner Center
Cincinnati, Ohio, 45219, United States
University Hospital, Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Stern Cardiology
Germantown, Tennessee, 38138, United States
Texas Heart Institute
Houston, Texas, 77030, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 6, 2007
First Posted
September 10, 2007
Study Start
September 1, 2007
Primary Completion
February 1, 2019
Last Updated
July 21, 2017
Record last verified: 2017-07