Status:
TERMINATED
Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration
Lead Sponsor:
Capricor Inc.
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine whether Allogeneic Cardiosphere-Derived Cells (CAP-1002) is safe and effective in decreasing infarct size in patients with a myocardial infarction.
Eligibility Criteria
Inclusion
- Inclusion Criteria
- History of MI (STEMI or NSTEMI) 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 Creatine phosphokinase MB isoenzyme (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.
- History of percutaneous coronary intervention (PCI), with stent placement resulting in Thrombolysis in Myocardial Infarction (TIMI) flow = 3, in the coronary artery supplying the infarcted, dysfunctional territory and through which the treatment will be infused.
- At least one 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) prior to or during the screening period.
- For participants 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 or during the screening period.
- For participants 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 or during the screening period.
- Note: participants may screen as a Recent MI but be randomized into the Chronic MI strata if the infusion date is \> 90 days post-MI.
- Left ventricular infarct size of \>= 15% of left ventricular mass in the qualifying infarct-related region to be infused 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.
- No further revascularization clinically indicated at the time the participants is assessed for participation in the clinical trial.
- Ability to provide informed consent and follow-up with protocol procedures.
- Age \>= 18 years.
- Exclusion Criteria
- Participants with a history of coronary artery bypass surgery, and a patent graft (arterial or saphenous vein graft) attached to the coronary artery to be infused.
- Diagnosed or suspected myocarditis.
- History of cardiac tumor, or cardiac tumor demonstrated on screening MRI.
- History of acute coronary syndrome in the 4 weeks prior to study infusion.
- History of previous stem cell therapy.
- History of radiation treatment to the central or left side of thorax.
- 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.
- 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-vascular endothelial growth factor, or chemotherapeutic agents within 3 months prior to enrollment.
- Prior implantable cardioverter defibrillator (ICD) and/or pacemaker placement where study imaging site has not been trained and certified specifically for this protocol to conduct cardiac MRI in participants 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.
- Estimated glomerular filtration rate \< 30 mL/min.
- Participation in an on-going protocol studying an experimental drug or device, or participation in an interventional clinical trial within the last 30 days.
- Diagnosis of arrhythmogenic right ventricular cardiomyopathy.
- Current alcohol or drug abuse.
- 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).
- Human Immunodeficiency Virus (HIV) infection.
- Viral hepatitis.
- Uncontrolled diabetes (HbA1c\>9%).
- Abnormal liver function (Serum Glutamic Pyruvic Transaminase/Alanine aminotransferase \> 3 times the upper reference range) and/or abnormal hematology (hematocrit \< 25%, White Blood Cell \< 3000 µl, platelets \< 100,000 µl) studies without a reversible, identifiable cause.
- 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.
- Ventricular fibrillation not associated with a new acute ischemic episode.
- New York Heart Association (NYHA) Class IV congestive heart failure.
- Evidence of tumor on screening chest/abdominal/pelvic (body) CT scan.
- Any prior transplant.
- Known hypersensitivity to dimethyl sulfoxide (DMSO).
- Known hypersensitivity to bovine products.
- Any malignancy within 5 years (except for in-situ non-melanoma skin cancer and in-situ cervical cancer) of signing the informed consent form.
- Any condition or other reason that, in the opinion of the Investigator or Medical Monitor, would render the participants unsuitable for the study.
Exclusion
Key Trial Info
Start Date :
November 13 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2019
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT01458405
Start Date
November 13 2012
End Date
February 28 2019
Last Update
April 9 2024
Active Locations (32)
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1
Cardiology, P.C.
Birmingham, Alabama, United States, 35211
2
Heart Center Research
Huntsville, Alabama, United States, 35801
3
Scripps
La Jolla, California, United States, 92037
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048