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Ischemic CardiomyopathyPhase 2CAuSMIc IINCT00626314

Study to Assess the Efficacy and Safety of Transplanting Autologous Skeletal Myoblasts, Into Infarcted Heart, Using an Catheter Delivery System

A Phase 2 study testing myoblast in people with Ischemic Cardiomyopathy, run by Mytogen, Inc. at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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 purpose of this study is to evaluate the safety and effectiveness of injecting myoblasts (grown from your own skeletal muscle), using a catheter device, directly into the damaged heart muscle for treatment of severe heart failure. Read more about this study

Who is it for?
Ages 21 to 75 years
Conditions the study is for
Ischemic Cardiomyopathy
What is being tested?
myoblast
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
165 participants
Where
1 siteUnited States
Study dates
Mar 2008to Aug 2010
Phase
Phase 2
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 21 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects with ischemic cardiomyopathy and previous myocardial infarction
  • New York Heart Association Classification III - ambulatory Class IV
  • Ejection fraction < 35% as determined by any method at baseline evaluation
  • Subjects could be considered for enrollment if CRT placement has occurred greater than three months previously with no clinical improvement, CRT settings are judged to be optimized and the subject continues to meet all other inclusion criteria (inadequate-responders).
  • Documentation of ineligibility for coronary revascularization and/or valve repair/ replacement by review of recent left heart catheterization (within six months of baseline).
  • Receiving optimally tolerated doses of standard, stable pharmacotherapy, including angiotensin-converting enzyme inhibitors, unless intolerant or contra-indicated, diuretics, ß-receptor blockers for at least one month prior to enrollment
  • Severe myocardial perfusion abnormality documented by SPECT imaging, involving at least 1/3 of a vascular territory, as confirmed by core lab.

Who cannot join

  • Age < 21 years or > 75 years.
  • Significant coronary stenosis, as determined by the Investigator, which may potentially require percutaneous or surgical revascularization within 12 weeks of enrollment.
  • Recent (within 4 weeks), documented acute coronary syndrome, i.e. (Q wave or non-Q wave infarction) or hospitalization for unstable angina.
  • Documented cerebrovascular accident (stroke) or TIA within 60 days.
  • Left ventricular thrombus (mobile or mural-based) as evidenced by ventriculogram or echocardiography.
  • Clinically significant electrocardiographic abnormalities that may interfere with subject safety during the intracardiac mapping and injection procedure. Patients with right bundle branch block with basal septal infarction.
Show all 25Show fewer
  • Subjects with CRT placement within three months of enrollment or intent to insert CRT, or CRT settings not judged to be optimized
  • High grade atrioventricular block not corrected by permanent pacemaker or ICD.
  • Frequent or recurrent, ventricular tachycardia in absence of an ICD.
  • Atrial fibrillation with uncontrolled ventricular response
  • Significant uncorrected valvular disease, which results in additional hemodynamic compromise and/or would require valvular repair or replacement. Patients with severe aortic stenosis or status-post mitral or aortic mechanical valve replacement.
  • Severe peripheral vascular disease, such that femoral access would be prohibited.
  • INR > 1.5 in absence of coumadin or partial thromboplastin time (PTT) >20% above ULN, or thrombocytopenia (platelet count < 75,000).
  • Significant renal dysfunction (e.g., creatinine >2.5 mg/dL) or liver disease (e.g., serum glutamic-oxaloacetic transaminases / aspartate aminotransferase SGOT/AST or serum glutamic-pyruvic transaminases/alanine aminotransferase SGPT/ALT > 4 x upper limit of normal [ULN]).
  • Currently enrolled, or have been enrolled within 30 days, in another investigational drug or device study that has not completed the protocol required follow-up period.
  • Subjects who have received a prior investigational stem cell or angiogenic agent.
  • Subjects who have tested positive for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and/or Hepatitis C Virus (HCV).
  • History of skeletal muscle disease, e.g. family history of acute or chronic skeletal muscle disease including infectious, drug-induced, familial, autoimmune and idiopathic myopathies.
  • Creatine phosphokinase (CK) or lactate dehydrogenase elevated greater than three times normal or unexplained elevations of CK.
  • Female subjects who are pregnant or nursing or any subject with reproductive capabilities unwilling to use effective birth control for the duration of the study period.
  • Evidence of concurrent infection of any type (e.g. Elevated white blood cell count {WBC>13,000}, temperature of >38.5 C, or infiltrate on chest x-ray).
  • Any other major illness, which, in the Investigator's judgment, will interfere with the subject's ability to comply with the protocol, compromises subject safety, or interferes with the interpretation of the study results.
  • Idiopathic Cardiomyopathy, hypertrophic cardiomyopathy
  • Subjects with ventricular wall thickness in the infarct zone of < 5 mm measured by echocardiogram at baseline.
  • Patients on chronic (or chronic intermittent) IV inotropic medication. -

Trial locations and contacts

1 site in 1 country.

JEROMY BROWN contact

617-423-7999 ext. 124

JBrown@ccstrials.com

United States1 site

  • Mercy Gilbert

    Gilbert, Arizona, 85297

    NABIL DIB, MD

Other trials in United States

About this study

Official title: A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Trial to Assess the Efficacy, Safety and Tolerability of Transplanting Autologous Skeletal Myoblasts, Into Infarcted Myocardium, Using an Endomyocardial Delivery System

The purpose of this study is to evaluate the safety and effectiveness of injecting myoblasts (grown from your own skeletal muscle), using a catheter device, directly into the damaged heart muscle for treatment of severe heart failure.

Read the detailed description

Given the limited treatment options available to patients with congestive heart failure, there is a need for alternative therapies. Autologous skeletal myoblast transplantation has been demonstrated in pre-clinical studies to be a safe and effective treatment of heart failure. Initial clinical studies have shown that autologous myoblasts can be delivered into infracted myocardium by both direct epicardial and endomyocardial injection. However, autologous skeletal myoblast transplantation via percutaneous endomyocardial injection has the potential to play a significant role in such congestive heart failure patients without the need for surgical risk and general anesthesia. Thus, a Phase 2 clinical trial is proposed in order to evaluate the effectiveness of autologous myoblast delivered by endomyocardial injection for the treatment congestive heart failure.

Being tested
myoblast, sham

What participants receive

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

  • myoblastBiological

    autologous myoblast

  • shamBiological

    sham injection procedure

Study groups in NCT00626314
Study groupRoleWhat they receive
1Experimentalmyoblast
Receives: Biological: myoblast
2Sham comparatorsham injection procedure
Receives: Biological: sham

What is being measured

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

  1. Kansas City Cardiomyopathy Questionnaire

    Measured: 6 months

Secondary outcomes (1)

  1. Cardiovascular mortality

    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 posted29 Feb 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionMar 2010 (estimated)
  4. Study completionAug 2010 (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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
165 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00626314
Sponsor's protocol ID
EDAM06-5
Acronym
CAuSMIc II
Status last verified
Feb 2008
First submitted
21 Feb 2008
Last updated
29 Feb 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing myoblast in people with Ischemic Cardiomyopathy, run by Mytogen, Inc. at 1 site 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 7 inclusion and 25 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 29 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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.

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?

Contact JEROMY BROWN (617-423-7999 ext. 124, JBrown@ccstrials.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kansas City Cardiomyopathy Questionnaire (time frame: 6 months). 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 NCT00626314.

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 29 Feb 2008.

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