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Congestive Heart FailurePhase 1NCT00054678

MYOHEART™ (Myogenesis Heart Efficiency and Regeneration Trial)

A Phase 1 study testing MyoCell™ and MyoCath™ in people with Congestive Heart Failure and Coronary Artery Disease, run by Bioheart, Inc. at 5 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The MyoCell™ implantation using the MyoCath™ delivery catheter system may have the potential to add a new dimension to the management of post-infarct deterioration of cardiac function in subjects with congestive heart failure. Read more about this study

Who is it for?
Ages 30 to 80 years
What is being tested?
MyoCell™ and MyoCath™
Type of treatment
Medical device
How many people
20 participants
Where
5 sitesUnited States
Study dates
Feb 2003to Oct 2007
Phase
Phase 1
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 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Defined region of myocardial dysfunction related to previous myocardial infarction(s) involving the anterior, lateral, posterior or inferior walls, > 12 weeks (84 days) old at the scheduled time of MyoCell™ implantation
  • Patients who have had prior placement of an Implantable Cardioverter Defibrillator (ICD) which must be in place at least one month (30 days) prior to MyoCell™ implantation
  • New York Heart Association (NYHA) Symptom Class II or III on optimal medical therapy
  • Age > 30 and < 80 years old
  • Need for revascularization has been ruled out by coronary angiogram or noninvasive stress testing within six months (180 days) of screening
  • Able to undergo surgical biopsy of the skeletal muscle and successful culture of the harvested myoblasts Target region wall thickness > 6 mm by Echocardiography
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  • Left ventricular ejection fraction > 20% and < 40% by Radionuclide Ventriculography or Left Ventricular Angiography at screening
  • Able to give written informed consent
  • Able to walk a minimum distance of 300 meters during the 6-minute walk test

Who cannot join

  • Myocardial infarction within 12 weeks (84 days) prior to investigational procedure
  • New York Heart Association Symptom Class I or IV
  • Coronary Artery Bypass Grafting (CABG) within 3 months (90 days) prior to scheduled MyoCell™ implantation
  • Percutaneous Coronary Intervention (PCI) within 6 months (180 days) prior to MyoCell™ implantation
  • Canadian Heart Classification of angina > Class II or unstable angina
  • Any cardiac valve replacement
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  • Heart failure secondary to valvular disease
  • Aortic stenosis greater than mild degree
  • Left ventricular or atrial mural thrombus
  • Chronic pulmonary disease
  • Atherosclerosis and/or tortuosity of the aorta, iliac or femoral arteries of a degree which, in the judgment of the principal investigator, would impede or preclude the safe retrograde passage of the 8FR MyoCath™ delivery catheter
  • History of severe radiocontrast reaction
  • Known sensitivity to gentamicin sulfate and/or amphotericin-B
  • Previous angiogenic therapy and/or myocardial laser therapy
  • Exposure to any investigational drug or procedure within 1 month prior to study entry
  • The use or expected use of antineoplastic drugs or history of cancer within 5 years, except for basal cell carcinoma of the skin
  • Skeletal muscle disease, either primary (i.e., myopathy) or secondary (i.e., ischemic) or any underlying myopathy such as myasthenia gravis, muscular dystrophy, etc. as determined by a board certified pathologist examining sample of patients muscle biopsy
  • Serum creatinine > 2.5 mg/dL or end stage renal disease
  • Prostate Specific Antigen (PSA) suggestive of carcinoma of the prostate (i.e., > 4.0 ng/mL)
  • Carcinoembryonic Antigen (CEA) >5.0 ng/mL or end stage renal disease
  • Active infectious disease and/or who are known to have tested positive for HIV, HTLV, HBV-sAg, HCV, CMV and/or syphilis. If the panel includes antibodies to the HBc and HBV-sAg, then an expert will be consulted as to patient eligibility based on the patient's infectious status
  • Females who are pregnant or nursing
  • Females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
  • Morbid obesity - more than 100 pounds over ideal body weight or Body Mass Index (BMI) > 40
  • Any illness which might affect patient's survival over the study 12 month follow-up period*
  • Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
  • No written Informed Consent or unable to provide informed consent

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • American CardioVascular Research Institute

    Atlanta, Georgia, 30342

  • Cleveland Clinic Heart Center

    Cleveland, Ohio, 44195

  • Minneapolis Heart Institute / Abbot Northwestern

    Minneapolis, Minnesota, 55407

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • SPONSOR: Bioheart, Inc

    Sunrise, Florida, 33325

Other trials in United States

About this study

Official title: A Phase I, Open-Label, Non-Randomized, Dose Escalation, Multi Center Study to Assess the Safety and Cardiovascular Effects of Autologous Skeletal Myoblast Implantation by a Transendocardial Catheter Delivery System in Congestive Heart Failure Patients Post Myocardial Infarction(s) With Previous Placement of ICD

The MyoCell™ implantation using the MyoCath™ delivery catheter system may have the potential to add a new dimension to the management of post-infarct deterioration of cardiac function in subjects with congestive heart failure. Based on pre-clinical studies, implantation of autologous skeletal myoblasts may lead to replacement of non-functioning myocardial scar with functioning muscle and improvement in myocardial performance. Preliminary data in human subjects suggest skeletal myoblast implantation at the time of CABG may lead to the same effects. In principal, myoblast implantation by catheter delivery may offer the same therapeutic benefit. The present clinical study is to be conducted primarily to evaluate the safety of MyoCell™ implantation using the MyoCath™ delivery system and secondarily to evaluate the effect on regional myocardial function post treatment.

Read the detailed description

A very promising approach to reversal or stabilization of the post-infarct remodeling process is the direct injection of regenerative cells into the myocardial infarct scar. Such cell-based therapy for cardiac repair is called "cellular cardiomyoplasty".

The MyoCell™ implantation using the MyoCath™ delivery catheter system may have the potential to add a new dimension to the management of post-infarct deterioration of cardiac function in subjects with congestive heart failure. MyoCath™ is Bioheart's proprietary catheter delivery system being developed by Bioheart to facilitate MyoCell™ delivery into the myocardium via the retrograde catheterization of the left ventricular cavity. Based on pre-clinical studies, implantation of autologous skeletal myoblasts may lead to replacement of non-functioning myocardial scar with functioning muscle and improvement in myocardial performance. Preliminary data in human subjects suggest skeletal myoblast implantation at the time of CABG or via the endoventricular approach may lead to the same effects. In principle, myoblast implantation by catheter delivery may offer the same therapeutic benefit.

The present clinical study is to be conducted primarily to:

  1. Assess the safety and effect on myocardial function of MyoCell™ (autologous skeletal myoblast) using a dose escalation methodology following implantation into myocardial scar tissue of subjects with congestive heart failure who have experienced previous myocardial infarction(s) and have had an implantable cardioverter defibrillator (ICD) previously implanted. Safety endpoints will be the evaluation of the nature and frequency of Adverse Events during the 12-month period following MyoCell™ treatment.
  2. To assess the safety and feasibility of using the transendocardial injection catheter (MyoCath™) as a system for delivering MyoCell™ into myocardial scar tissue of subjects with congestive heart failure who have experienced previous myocardial infarction(s) and have an implantable cardioverter defibrillator (ICD) previously implanted. Catheter performance will be assessed at the time of the implantation using clinical evaluation questionnaires. Safety endpoints will be the evaluation of the nature and frequency of Adverse Events from the time of implantation to the Day 14 follow-up visit.

If a patient meets the baseline enrollment criteria, approximately 5-10 grams of skeletal muscle is obtained from the subject's leg muscle for myoblast isolation and expansion in vitro (MyoCell™) at a specified off site cGMP culture laboratory. The expanded myoblast cells, MyoCell™ will be implanted into the akinetic myocardial scar in the region of a previous infarct utilizing Bioheart's MyoCath™ transendocardial delivery catheter system. The MyoCath™ endoventricular device is expected to deliver the MyoCell™ autologous skeletal myoblast cells into the scarred myocardial region by steering a catheter which contains a retractable hypodermic needle to the targeted sites for implantation.

This will be a dose escalation study with 4 cohort groups consisting of 5 patients each. A report of the 1 month safety data from each cohort will be presented to the Data Safety Monitoring Board for permission to go to the next higher dosage. In the first cohort of this dose escalation study, 2 injections will be performed; for the second cohort, 6 injections; for the third cohort, 18 injections; and for the fourth cohort, 27 injections, depending on the size of the infarct scar, so as to inject the entire myocardial infarct scar akinetic area.

The entire study is expected to be completed during the first half of 2007, including completed enrollment as well as 12-month follow-up of the last subject.

Being tested
MyoCell™, MyoCath™
Keywords
Myocardial infarction, Heart disease, Endoventricular, Cardiovascular, Interventional, ICD, Heart failure, Implantable Cardioverter Defibrillator
Medical subject headings
Heart Failure, Coronary Artery Disease, Myocardial Infarction, Heart Diseases

What participants receive

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

  • MyoCell™Drug

  • MyoCath™Device

What is being measured

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

  1. To assess the safety of Myocel following implantation into myocardial scar tissue of subjects with congestive heart failure who have experienced previous MI.

Timeline

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

  1. First posted7 Feb 2003 (estimated)
  2. Study startFeb 2003
  3. Study completionOct 2007 (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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00054678
Sponsor's protocol ID
BMI-US-01-002
Other IDs
Version G
Status last verified
Oct 2007
First submitted
6 Feb 2003
Last updated
15 Oct 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MyoCell™ and MyoCath™ in people with Congestive Heart Failure and Coronary Artery Disease, run by Bioheart, Inc. at 5 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 9 inclusion and 27 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 15 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

To assess the safety of Myocel following implantation into myocardial scar tissue of subjects with congestive heart failure who have experienced previous MI.. 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 NCT00054678.

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 15 Oct 2007.

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