We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    MARVEL bioheart
Previous Study | Return to List | Next Study

To Assess Safety and Efficacy of Myoblast Implantation Into Myocardium Post Myocardial Infarction (MARVEL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00526253
Recruitment Status : Unknown
Verified July 2017 by Bioheart, Inc..
Recruitment status was:  Active, not recruiting
First Posted : September 10, 2007
Last Update Posted : July 21, 2017
Information provided by:
Bioheart, Inc.

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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Biological: MyoCell Procedure: Hypothermosol Phase 2 Phase 3

Detailed Description:
Autologous myoblasts are harvested from a patient's skeletal muscle tissue. The myoblasts are isolated and expanded in culture in a closed system. When a sufficient number of cells are estimated they are taken from culture, packaged in a suspension and sent to the patient's interventionalist. The interventionalist uses an injection catheter via femoral artery to inject the myoblasts directly into the myocardium.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : September 2007
Estimated Primary Completion Date : February 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Low Dose
Patient will undergo biopsy. Skeletal myoblasts will be cultured in growth media.
Biological: MyoCell
Patient will receive injections of cultured, expanded skeletal myoblasts into the myocardium at a dose of 400 million cells.

Active Comparator: High Dose
Patient will undergo biopsy. Skeletal myoblasts will be cultured in growth media.
Biological: MyoCell
Patient will receive injections of cultured, expanded skeletal myoblasts into the myocardium at a dose of 800 million cells.

Placebo Comparator: Control
Patient will undergo biopsy of muscle tissue and biopsy tissue will be sent to lab.
Procedure: Hypothermosol
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.

Primary Outcome Measures :
  1. 6-minute walk test [ Time Frame: 6 months ]
  2. Quality of Life Questionnaire [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Hospitalization occurrences [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Eligible patients must meet ALL of the following inclusion criteria during the screening/enrollment visit #1 and prior to being randomized into the study. Screening/enrollment visit #1 is defined to start the date the ICF is signed by the patient:

  1. Chronic CHF, New York Heart Association (NYHA) Class II-IV;
  2. Stable and on optimal medical management for greater or equal to 60 days as follows:

    1. systolic and diastolic hypertension controlled in accordance with contemporary guidelines;
    2. patient stabilized on maximum tolerated dose of beta blockers;
    3. patient stabilized on maximum tolerated dose of angiotensin concerting enzyme (ACE) inhibitors;
    4. patients intolerant of ACE inhibitors should be stabilized on angiotensin receptor blockers (ARB);
    5. fluid control with diuretics and a salt restricted diet;
    6. 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.
  3. Age 18-80;
  4. Left ventricular ejection fraction (LVEF) at screening of less than or equal to 35 percent by multiple gaited acquisition scan (MUGA);
  5. 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);
  6. 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);
  7. B-type natriuretic peptide (BNP) or NT pro-BNP is above the upper limit of normal.

Exclusion Criteria:

  1. 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;
  2. Myocardial wall thickness of <6 mm (millimeters) in the akinetic myocardial region to be injected (using DSE at screening)
  3. Inability to undergo a surgical biopsy of the skeletal muscle for culture of myoblasts, including any significant myopathy;
  4. Patient will require revascularization within six months;
  5. Patients on continuous or intermittent intravenous drug therapy;
  6. Not fitted, or fitted within less than 90 days prior to screening visit #1, with an implantable cardioverter defibrillator (ICD);
  7. Sustained ventricular tachycardia (VT), automatic implantable cardiodefibrillator (AICD) firing, or ventricular fibrillation (VF) within 90 days prior to screening visit #1;
  8. Inability to perform a 6 minute walk test due to physical limitations other than HF including:

    1. Severe peripheral vascular disease, including aortic aneurysms, leading to limited claudication;
    2. Severe pulmonary disease or chronic obstructive pulmonary disease (COPD) limiting exercise, dependence on chronic oral steroid therapy or previously requiring mechanical ventilation;
    3. Stroke or transient ischemic attack leading to limitations in lower extremities or occurring within 180 days prior to screening visit #1;
  9. MI, unstable angina or percutaneous coronary intervention (PCI) within 90 days prior to screening;
  10. having undergone CABG surgery within 150 days prior to screening visit #1;
  11. Active myocarditis, constrictive pericarditis, restrictive, hypertrophic or congenital cardiomyopathy;
  12. Hemodynamically significant severe primary valvular heart disease, unless corrected by a properly functional prosthetic valve;
  13. Prior aortic valve replacement;
  14. Systolic blood pressure (supine) ≤90 mmHg;
  15. Resting heart rate >100 bpm;
  16. Severe uncontrolled HF including any evidence of severe fluid overload such as peripheral edema >+2 or rales ≥1/3 the lungs' height, need for intravenous therapy for HF within 60 days of screening visit #1 or hospitalization for HF within 90 days of screening visit #1;
  17. Patient scheduled to receive cardiac resynchronization therapy (CRT) during the study;
  18. Expected to receive or received a cardiac transplant, surgical remodeling procedure, left ventricular assist device or cardiomyoplasty;
  19. Six-minute walk test (6MWT) of >400 meters or Minnesota Living With Heart Failure (MLWHF) score of <20;
  20. Hematocrit (HCT) concentration below 30% (males) or below 27% (females);
  21. Serum creatinine greater than 2.5 mg/dL (milligrams per deciliter) or end stage renal disease;
  22. Left ventricular mural thrombus;
  23. Known sensitivity to gentamicin sulfate; or severe adverse reaction to nonionic radiocontrast agents;
  24. Active infectious disease and/or known to have tested positive for human immunodeficiency virus (HIV), human t lymphotrophic virus (HTLV), hepatitis B virus (HBV), hepatitis C virus (HCV), cytomegalovirus (CMV); immunoglobulin M [IgM], and/or syphilis. If the panel includes antibodies to the HBV core antigen (HBV-cAg) and hepatitis B surface antigen (HBV-sAg), then an expert will be consulted as to patient's eligibility based on the patient's infectious status;
  25. Patients have undergone enhanced external pulsation (EECP) tratment within the last 6 months;
  26. Exposure to any previous experimental angiogenic therapy and/or myocardial laser therapy, or therapy with another investigational drug within 60 days of screening visit #1 or enrollment in any concurrent study that may confound the results of this study;
  27. Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or in the opinion of the investigator are not suitable to participate;
  28. Any illness other than CHF which might reduce life expectancy to less than 1 year from screening visit #1;
  29. Recent initiation of cardiac resynchronization therapy via placement of a bi-ventricular pacemaker or bi-ventricular AICD within 180 days of study enrollment; and

30 Unwilling and/or not able to give written informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00526253

Hide Hide 33 study locations
Layout table for location information
United States, Alabama
Cardiology, P.C.
Birmingham, Alabama, United States, 35211
University of Alabama
Birmingham, Alabama, United States, 35294
United States, Arizona
Mercy Gilbert Medical Center
Gilbert, Arizona, United States, 85297
Arizona Heart Institute
Phoenix, Arizona, United States, 85006
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
United States, California
Scripps Green Hospital
La Jolla, California, United States, 92037
UCSD Medical Center
La Jolla, California, United States, 92103
United States, Florida
Jim Moran Heart and Vascular Research Institute
Fort Lauderdale, Florida, United States, 33317
University of Florida
Gainesville, Florida, United States, 32610
University of Florida Shands
Jacksonville, Florida, United States, 32209
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Florida Hospital Center Cardiovascular Center
Orlando, Florida, United States, 32803
United States, Georgia
Emory/Crawford Long
Atlanta, Georgia, United States, 30308
St. Joseph's Research Institute/ACRI
Atlanta, Georgia, United States, 30342
United States, Illinois
RUSH University Medical Center
Chicago, Illinois, United States, 60612
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Louisiana
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
United States, Minnesota
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
United States, New Jersey
Our Lady of Lourdes Medical Center
Camden, New Jersey, United States, 08103
Gagnon Heart Hospital
Morristown, New Jersey, United States, 07962
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
The Lindner Center
Cincinnati, Ohio, United States, 45219
University Hospital, Case Western Reserve University
Cleveland, Ohio, United States, 44106
Cleveland Clinic
Cleveland, Ohio, United States, 44195
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Stern Cardiology
Germantown, Tennessee, United States, 38138
United States, Texas
Texas Heart Institute
Houston, Texas, United States, 77030
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
United States, Wisconsin
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Bioheart, Inc.
Additional Information:
Layout table for additonal information
Responsible Party: Warren Sherman, MN, Center for Interventional Vascular Therapy
ClinicalTrials.gov Identifier: NCT00526253    
Other Study ID Numbers: BMI-WW-02-003
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Keywords provided by Bioheart, Inc.:
Congestive Heart Failure
Heart Disease
Heart Attack
Stem Cell
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases