Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration (ALLSTAR)

This study is currently recruiting participants.
Verified April 2014 by Capricor Inc.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Capricor Inc.
ClinicalTrials.gov Identifier:
NCT01458405
First received: October 20, 2011
Last updated: April 1, 2014
Last verified: April 2014

October 20, 2011
April 1, 2014
October 2012
October 2015   (final data collection date for primary outcome measure)
Infarct size assessed by MRI [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

The primary safety endpoint is the proportion of patients that experience active myocarditis possibly attributable to treatment accompanied by the presence of circulating antibodies specific to the CAP-1002 CDC donor, death due to ventricular tachycardia or ventricular fibrillation, sudden unexpected death, or a major adverse cardiac event (MACE).

The primary efficacy endpoint is relative percentage improvement in infarct size assessed by MRI for the CAP-1002 group compared to the placebo group at Months 6 and 12 post-infusion.

Infarct size assessed by MRI
Complete list of historical versions of study NCT01458405 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration
Randomized, Double-Blind, Placebo-Controlled Phase I/II Study of the Safety and Efficacy of Intracoronary Delivery of Allogeneic Cardiosphere-Derived Cells in Patients With an Anterior Myocardial Infarction and Ischemic Left Ventricular Dysfunction

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Myocardial Infarction
Biological: CAP-1002 Allogeneic Cardiosphere-Derived Cells
Single dose, intracoronary infusion of 25 Million cardiosphere-derived cells or placebo
  • Placebo Comparator: Placebo
    Intervention: Biological: CAP-1002 Allogeneic Cardiosphere-Derived Cells
  • Active Comparator: CAP-1002 Allogeneic Cardiosphere-Derived Cells
    Intervention: Biological: CAP-1002 Allogeneic Cardiosphere-Derived Cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
274
December 2015
October 2015   (final data collection date for primary outcome measure)

Inclusion Criteria

  1. History of anterior MI within the prior 4 weeks to 12 months due to coronary artery atherosclerotic disease and evidenced by typical ischemic symptoms, serial ST-T changes (new ST elevation or new left bundle block) and elevated troponin or CK-MB >5 times the upper limit of normal with at least one of the following, based on standardly accepted definition of acute MI: development of pathological Q wave ECG changes, imaging evidence of new loss of viable myocardium, or new regional wall motion abnormalities.
  2. History of percutaneous coronary intervention (PCI), with stent placement resulting in TIMI flow = 3, in the left anterior descending 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, ventriculogram, nuclear imaging, CT and/or MRI). Recent MI: assessment must be post-reperfusion after index MI and be the most recent test prior to signing informed consent. Chronic MI: assessment must be at least 21 days post-reperfusion after index MI and the most recent test prior to signing informed consent.
  4. Left ventricular infarct size of ≥ 15% of left ventricular mass as determined by screening MRI, with associated thinning and/or hypokinesis, akinesis, or dyskinesis, with no large aneurysmal area in the anterior/anterolateral/anteroseptal regions . In subjects with infarcts in >1 myocardial wall, >50% of the total LV scar should be in the anterior/anterolateral/anteroseptal 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. Subjects with a history of coronary artery bypass surgery, and a graft (left internal mammary artery or saphenous vein graft) attached to the left anterior descending coronary artery.
  2. Diagnosed or suspected myocarditis.
  3. History of cardiac tumor, or cardiac tumor demonstrated on screening MRI.
  4. History of previous stem cell therapy.
  5. History of radiation treatment to the chest or thorax.
  6. 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.
  7. 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.
  8. Contraindications to MRI, including prior ICD and/or pacemaker placement, estimated glomerular filtration rate < 30 mL/min.
  9. Non-cardiovascular disease with life expectancy of < 3 years.
  10. Participation in an on-going protocol studying an experimental drug or device or participation in an interventional clinical trial within the last 30 days.
  11. Diagnosis of arrhythmogenic right ventricular cardiomyopathy.
  12. Current alcohol or drug abuse or an inability to comply with protocol-related procedures.
  13. Pregnant/nursing women and women of child-bearing potential without use of active and highly reliable contraception.
  14. Human Immunodeficiency Virus (HIV) infection.
  15. Viral hepatitis.
  16. Uncontrolled diabetes (HbA1c>9%)
  17. Abnormal liver function (SGPT > 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.
  18. 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.
  19. Ventricular fibrillation not associated with a new acute ischemic episode.
  20. New York Heart Association (NYHA) Class IV congestive heart failure.
  21. Evidence of tumor on screening chest/abdominal/pelvic (body) CT scan.
  22. Any prior transplant.
  23. Known hypersensitivity to dimethyl sulfoxide (DMSO)
  24. Known hypersensitivity to bovine products.
  25. Any malignancy within 5 years (except for in-situ non-melanoma skin cancer and in-situ cervical cancer).
Both
18 Years and older
No
Not Provided
United States
 
NCT01458405
1002-01, RC3HL103356-01
Yes
Capricor Inc.
Capricor Inc.
  • National Institutes of Health (NIH)
  • National Heart, Lung, and Blood Institute (NHLBI)
Study Director: Katherine A Beattie, BAN, CCRC Capricor Inc.
Capricor Inc.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP