Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration (ALLSTAR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Capricor Inc.
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Capricor Inc. Identifier:
First received: October 20, 2011
Last updated: March 31, 2015
Last verified: March 2015
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.

Condition Intervention Phase
Myocardial Infarction
Biological: CAP-1002 Allogeneic Cardiosphere-Derived Cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Capricor Inc.:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 274
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Biological: CAP-1002 Allogeneic Cardiosphere-Derived Cells
Single dose, intracoronary infusion of 25 Million cardiosphere-derived cells or placebo
Active Comparator: CAP-1002 Allogeneic Cardiosphere-Derived Cells Biological: CAP-1002 Allogeneic Cardiosphere-Derived Cells
Single dose, intracoronary infusion of 25 Million cardiosphere-derived cells or placebo


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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). 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 be 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 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 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 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 of planned ICD and/or pacemaker placement.
  10. Estimated glomerular filtration rate < 30 mL/min.
  11. Participation in an ongoing 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 or an inability to comply with protocol-related procedures.
  14. Pregnant/nursing women and women of child-bearing potential without use of active and highly reliable contraception.
  15. Human Immunodeficiency Virus (HIV) infection.
  16. Viral hepatitis.
  17. Uncontrolled diabetes (HbA1c>9%)
  18. 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.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01458405

  Show 25 Study Locations
Sponsors and Collaborators
Capricor Inc.
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Study Director: Andrew Hamer, MBChB FRACP Capricor Inc.
  More Information

No publications provided

Responsible Party: Capricor Inc. Identifier: NCT01458405     History of Changes
Other Study ID Numbers: 1002-01  RC3HL103356-01 
Study First Received: October 20, 2011
Last Updated: March 31, 2015
Health Authority: United States: Food and Drug Administration
United States: National Heart, Lung and Blood Institute

Keywords provided by Capricor Inc.:
Myocardial Infarction
Heart Attack
Stem cell
Left ventricular dysfunction
Congestive heart failure

Additional relevant MeSH terms:
Anterior Wall Myocardial Infarction
Myocardial Infarction
Ventricular Dysfunction
Ventricular Dysfunction, Left
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Pathologic Processes
Vascular Diseases processed this record on February 04, 2016