ALLSTAR

Principal Investigator: Craig Selzman
Keywords: Stem Cell , Heart , Coronary Artery Disease , Ejection Fraction , ischemic heart disease Department: Cardiothoracic Division
IRB Number: 00071563 Co Investigator: Anwar  Tandar
Specialty: Cardiology, Cardiothoracic Surgery, Cardiothoracic Surgery
Sub Specialties: Heart Stem Cell Therapy
Recruitment Status: Recruiting

Contact Information

Carlyn Sander
carlyn.sander@hsc.utah.edu
8015875727

Brief Summary

Primary Objective(s):

To determine the safety profile of CAP-1002 administered by intracoronary infusion in patients with ischemic left ventricular dysfunction and a previous anterior myocardial infarction (MI).

Secondary Objective(s):

To evaluate whether administration of CAP-1002 by intracoronary infusion may result in structural cardiac or functional clinical benefits for patients with ischemic left ventricular dysfunction and a previous anterior myocardial infarction (MI).

 

Inclusion Criteria

1. History of MI within the prior 12 months due to a coronary artery event and evidenced by at
least two of the following: typical ischemic symptoms, serial ST-T changes (new ST
elevation or new left bundle block) and/or elevated troponin or CK-MB >5 times the upper
limit of normal. Also at least one of the following: development of pathological Q wave ECG
changes, imaging evidence of new loss of viable myocardium, or new regional wall motion
abnormalities.
 The following assessments will be permitted within 28 days immediately following
the subject’s MI: signing ICF, review of medical history, review of concomitant
medications, and collection of laboratory samples required for assessment of study
eligibility criteria (e.g., eGFR, HbA1c, hepatitis serology, HIV serology, LFTs,
hematocrit, WBC, and platelet count). All other screening tests, including the
subject’s cardiac MRI and CT (chest, abdomen, pelvis), must be conducted greater
than 28 days post-MI. Infusion must occur within 28 days of the first screening
procedure that is performed greater than 28 days post-MI. Relevant safety laboratory
sample collections (e.g., chemistry, hematology, urinalysis) may need to be repeated
as they must be obtained within 28 days of the subject’s infusion.
2. History of percutaneous coronary intervention (PCI), with stent placement resulting in TIMI
flow = 3, in the coronary artery supplying the infarcted, dysfunctional territory and through
which the treatment will be infused.
3. At least one historical assessment of left ventricular ejection function (LVEF) ≤0.45 as
determined by any one of the standard modalities (echocardiography, ventriculography,
nuclear imaging, CT and/or MRI). For subjects that fulfill the criteria of Recent MI (i.e.,
within 90 days of MI) at time of screening visit: assessment must be post-reperfusion after
index MI and the most recent test prior to signing informed consent. For subjects that fulfill
the criteria of Chronic MI (i.e., greater than 90 days from MI) at the time of screening visit:
assessment must be at least 21 days post-reperfusion after index MI and the most recent test
prior to signing informed consent. Note: subjects may screen as a Recent MI but be
randomized into the Chronic MI strata if the infusion date is > 90 days post-MI.
4. Left ventricular infarct size of ≥ 15% of left ventricular mass as determined by centrally read
screening MRI, with associated thinning and/or hypokinesis, akinesis, or dyskinesis, with no
large aneurysmal area in the infarcted regions. In subjects with infarcts in >1 myocardial
wall, >50% of the total LV scar should be in the infarcted regions.
5. No further revascularization clinically indicated at the time the subject is assessed for
participation in the clinical trial.
6. Ability to provide informed consent and follow-up with protocol procedures.
7. Age ≥ 18 years.

 

Exclusion Criteria

  1. 1. Subjects with a history of coronary artery bypass surgery, and a graft (arterial or saphenous
    vein graft) attached to the coronary artery to be infused.
    2. Diagnosed or suspected myocarditis.
    3. History of cardiac tumor, or cardiac tumor demonstrated on screening MRI.
    4. History of acute coronary syndrome in the 4 weeks prior to study infusion.
    5. History of previous stem cell therapy.
    6. History of radiation treatment to the central or left side of thorax.
    7. Current or history (within the previous 5 years) of systematic auto-immune or connective
    tissue disease including, but not limited to, giant cell myocarditis, cardiac or systemic
    sarcoidosis, Dressler’s syndrome, chronic recurrent or persistent pericarditis.
    8. History of or current treatment with immunosuppressive , anti-inflammatory, or other agents
    to treat manifestations of systemic immunologic reactions, including chronic systemic
    corticosteroids, biologic agents targeting the immune system, anti-tumor and anti-neoplastic
    drugs, anti-VEGF, or chemotherapeutic agents within 3 months prior to enrollment.
    9. Prior ICD and/or pacemaker placement where study imaging site has not been trained and
    certified specifically for this protocol to conduct cardiac MRI in subjects with ICD and/or
    pacemaker placement.
    a. Presence of a pacemaker and/or ICD generator with any of the following
    limitations/conditions are excluded:
    i. Manufactured before the year 2000,
    ii. Leads implanted < 6 weeks prior to signing informed consent,
    iii. Non-transvenous epicardial, abandoned, or no-fixation leads,
    iv. Subcutaneous ICDs,
    v. Leadless pacemakers,
    vi. Any other condition that, in the judgement of device-trained staff, would
    deem an MRI contraindicated.
    b. Pacemaker dependence with an ICD (Note: pacemaker-dependent candidates
    without an ICD are not excluded).
    c. A cardiac resynchronization therapy (CRT) device implanted < 3 months prior to
    signing informed consent.
    10. Estimated glomerular filtration rate < 30 mL/min.
    11. Participation in an on-going protocol studying an experimental drug or device, or
    participation in an interventional clinical trial within the last 30 days.
    12. Diagnosis of arrhythmogenic right ventricular cardiomyopathy.
    13. Current alcohol or drug abuse.
    14. Pregnant/nursing women and women of child-bearing potential that do not agree to use at
    least two forms of active and highly reliable method(s) of contraception. Acceptable methods
    of contraception include contraceptive pills, depo-progesterone injections, a barrier
    contraceptive such as a condom with or without spermicide cream or gel, diaphragms or
    cervical cap with or without spermicide or gel, or an intrauterine device (IUD).
    15. Human Immunodeficiency Virus (HIV) infection.
    16. Viral hepatitis.
    17. Uncontrolled diabetes (HbA1c>9%).
    18. Abnormal liver function (SGPT/ALT > 3 times the upper reference range) and/or abnormal
    hematology (hematocrit < 25%, WBC < 3000 μl, platelets < 100,000 μl) studies without a
    reversible, identifiable cause.
    CAP-1002 Allogeneic Cardiosphere-Derived Cells
    Clinical Trial Protocol: 1002-01
    Capricor, Inc
    05 June 2015
    Confidential Page 33 of 91 Amendment 7.1
    19. Sustained ventricular tachycardia (VT) or non-sustained ventricular tachycardia > 30 beats,
    not associated with the acute phase of a previous MI (> 48 hours after the MI onset) or a new
    acute ischemic episode.
    20. Ventricular fibrillation not associated with a new acute ischemic episode.
    21. New York Heart Association (NYHA) Class IV congestive heart failure.
    22. Evidence of tumor on screening chest/abdominal/pelvic (body) CT scan.
    23. Any prior transplant.
    24. Known hypersensitivity to dimethyl sulfoxide (DMSO).
    25. Known hypersensitivity to bovine products.
    26. Any malignancy within 5 years (except for in-situ non-melanoma skin cancer and in-situ
    cervical cancer) of signing the ICF.
    27. Any condition or other reason that, in the opinion of the Investigator or Medical Monitor,
    would render the subject unsuitable for the study.