ClinicalTrials.gg
Status unknownNCT00526253MARVELUpdated Jul 21, 2017

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

A Phase 2/3 interventional study of MyoCell and MyoCell in Congestive Heart Failure, sponsored by Bioheart, Inc.. Status unknown at 33 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-07-21.

Sponsored by Bioheart, Inc. · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Congestive Heart Failure

Keywords

  • Congestive Heart Failure
  • CHF
  • Heart Disease
  • Heart Attack
  • Stem Cell
  • Myoblast
  • Bioheart
03

In context

Heart Failure

5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.

This study's planned enrollment of 170 is above the median of 72 across 3,790 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Bioheart, Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
170 participants (estimated)

Study arms

  • Active comparator
    Low Dose

    Patient will undergo biopsy. Skeletal myoblasts will be cultured in growth media.

    Biological: MyoCell

  • Active comparator
    High Dose

    Patient will undergo biopsy. Skeletal myoblasts will be cultured in growth media.

    Biological: MyoCell

  • Placebo comparator
    Control

    Patient will undergo biopsy of muscle tissue and biopsy tissue will be sent to lab.

    Procedure: Hypothermosol

Interventions

  • BiologicalMyoCell

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

  • BiologicalMyoCell

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

  • ProcedureHypothermosol

    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.

06

What researchers measure

Primary outcomes

  1. 6-minute walk test

    Time frame: 6 months

  2. Quality of Life Questionnaire

    Time frame: 6 months

Secondary outcomes

  1. Hospitalization occurrences

    Time frame: 12 months

07

Study locations

33 sites
  • 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
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00526253
Lead sponsor
Bioheart, Inc.
First posted
Sep 10, 2007
Start date
Sep 2007
Primary completion
Feb 2019 (estimated)
Last update
Jul 21, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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