Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Myocardial Infarction

In brief

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.

Key facts

Study ID

NCT01458405

Run by

Capricor Inc.

People needed

135

Starts

2012-11-13

Expected to finish

2019-02-28

Last updated by the study team

2024-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cardiology, P.C. — Birmingham, Alabama, United States
• Heart Center Research — Huntsville, Alabama, United States
• Scripps — La Jolla, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of Florida - Shands Hospital — Gainesville, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Prairie Heart - St. John's Hospital — Springfield, Illinois, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• UMass Memorial Medical Center — Worcester, Massachusetts, United States
• Michigan CardioVascular Institute — Saginaw, Michigan, United States
• Metropolitan Heart and Vascular Institute / Mercy Hospital — Coon Rapids, Minnesota, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• University at Buffalo — Buffalo, New York, United States
• Lenox Hill Hospital — New York, New York, United States
• Carolinas HealthCare System — Charlotte, North Carolina, United States
• Duke University Hospital — Durham, North Carolina, United States
• NC Heart & Vascular Research — Raleigh, North Carolina, United States
• SUMMA Health System — Akron, Ohio, United States
• Lindner Center for Research and Education at the Christ Hospital — Cincinnati, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• OhioHealth Research Institute — Columbus, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• The Miriam Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.