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

July 20, 2017 updated by: Bioheart, Inc.

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama
      • Birmingham, Alabama, United States, 35211
        • Cardiology, P.C.
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Mercy Gilbert Medical Center
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Hospital
      • Phoenix, Arizona, United States, 85006
        • Arizona Heart Institute
    • California
      • La Jolla, California, United States, 92037
        • Scripps Green Hospital
      • La Jolla, California, United States, 92103
        • UCSD Medical Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33317
        • Jim Moran Heart and Vascular Research Institute
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Jacksonville, Florida, United States, 32209
        • University of Florida Shands
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine
      • Orlando, Florida, United States, 32803
        • Florida Hospital Center Cardiovascular Center
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory/Crawford Long
      • Atlanta, Georgia, United States, 30342
        • St. Joseph's Research Institute/ACRI
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Our Lady of Lourdes Medical Center
      • Morristown, New Jersey, United States, 07962
        • Gagnon Heart Hospital
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Lindner Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44106
        • University Hospital, Case Western Reserve University
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Stern Cardiology
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Heart Institute
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Biological: MyoCell
Patient will receive injections of cultured, expanded skeletal myoblasts into the myocardium at a dose of 800 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 400 million cells.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
6-minute walk test
Time Frame: 6 months
6 months
Quality of Life Questionnaire
Time Frame: 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Hospitalization occurrences
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bioheart, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2007

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2007

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2007

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BMI-WW-02-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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