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Congestive Heart FailurePhase 2/3MARVELNCT00526253

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

A Phase 2/3 study testing MyoCell and Hypothermosol in people with Congestive Heart Failure, run by Bioheart, Inc. at 33 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Congestive Heart Failure
What is being tested?
MyoCell and Hypothermosol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
170 participants
Where
33 sitesUnited States
Study dates
Sep 2007to Feb 2019
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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;
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  • 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.

Who cannot join

  • 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);
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  • 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;
  • Prior aortic valve replacement;
  • Systolic blood pressure (supine) ≤90 mmHg;
  • Resting heart rate >100 bpm;
  • 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;
  • Patient scheduled to receive cardiac resynchronization therapy (CRT) during the study;
  • Expected to receive or received a cardiac transplant, surgical remodeling procedure, left ventricular assist device or cardiomyoplasty;
  • Six-minute walk test (6MWT) of >400 meters or Minnesota Living With Heart Failure (MLWHF) score of <20;
  • Hematocrit (HCT) concentration below 30% (males) or below 27% (females);
  • Serum creatinine greater than 2.5 mg/dL (milligrams per deciliter) or end stage renal disease;
  • Left ventricular mural thrombus;
  • Known sensitivity to gentamicin sulfate; or severe adverse reaction to nonionic radiocontrast agents;
  • 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;
  • Patients have undergone enhanced external pulsation (EECP) tratment within the last 6 months;
  • 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;
  • 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;
  • Any illness other than CHF which might reduce life expectancy to less than 1 year from screening visit #1;
  • 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.

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

United States33 sites

  • Emory/Crawford Long

    Atlanta, Georgia, 30308

  • St. Joseph's Research Institute/ACRI

    Atlanta, Georgia, 30342

  • Cardiology, P.C.

    Birmingham, Alabama, 35211

  • University of Alabama

    Birmingham, Alabama, 35294

  • Our Lady of Lourdes Medical Center

    Camden, New Jersey, 08103

  • RUSH University Medical Center

    Chicago, Illinois, 60612

  • The Lindner Center

    Cincinnati, Ohio, 45219

  • University Hospital, Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Jim Moran Heart and Vascular Research Institute

    Fort Lauderdale, Florida, 33317

  • University of Florida

    Gainesville, Florida, 32610

  • Stern Cardiology

    Germantown, Tennessee, 38138

  • Mercy Gilbert Medical Center

    Gilbert, Arizona, 85297

  • Texas Heart Institute

    Houston, Texas, 77030

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Florida Shands

    Jacksonville, Florida, 32209

  • Scripps Green Hospital

    La Jolla, California, 92037

  • UCSD Medical Center

    La Jolla, California, 92103

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136

  • St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • Gagnon Heart Hospital

    Morristown, New Jersey, 07962

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Columbia University Medical Center

    New York, New York, 10032

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • Florida Hospital Center Cardiovascular Center

    Orlando, Florida, 32803

  • Arizona Heart Institute

    Phoenix, Arizona, 85006

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Swedish Medical Center

    Seattle, Washington, 98122

Other trials in United States

About this study

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)

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.

Read the 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.

Being tested
MyoCell, Hypothermosol
Keywords
Congestive Heart Failure, CHF, Heart Disease, Heart Attack, Stem Cell, Myoblast, Bioheart
Medical subject headings
Heart Failure, Heart Diseases, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MyoCellBiological

    Patient will receive injections of cultured, expanded skeletal myoblasts into the myocardium at a dose of 400 million cells.

  • MyoCellBiological

    Patient will receive injections of cultured, expanded skeletal myoblasts into the myocardium at a dose of 800 million cells.

  • HypothermosolProcedure or surgery

    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.

Study groups in NCT00526253
Study groupRoleWhat they receive
Low DoseActive comparatorPatient will undergo biopsy. Skeletal myoblasts will be cultured in growth media.
Receives: Biological: MyoCell
High DoseActive comparatorPatient will undergo biopsy. Skeletal myoblasts will be cultured in growth media.
Receives: Biological: MyoCell
ControlPlacebo comparatorPatient will undergo biopsy of muscle tissue and biopsy tissue will be sent to lab.
Receives: Procedure: Hypothermosol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-minute walk test

    Measured: 6 months

  2. Quality of Life Questionnaire

    Measured: 6 months

Secondary outcomes (1)

  1. Hospitalization occurrences

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionFeb 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00526253
Sponsor's protocol ID
BMI-WW-02-003
Acronym
MARVEL
Status last verified
Jul 2017
First submitted
6 Sep 2007
Last updated
21 Jul 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing MyoCell and Hypothermosol in people with Congestive Heart Failure, run by Bioheart, Inc. at 33 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-minute walk test (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00526253.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.

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