Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration (ALLSTAR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Capricor Inc.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Capricor Inc.
ClinicalTrials.gov Identifier:
NCT01458405
First received: October 20, 2011
Last updated: July 14, 2014
Last verified: June 2014
  Purpose

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

  Eligibility

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

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).
  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 ClinicalTrials.gov identifier: NCT01458405

Locations
United States, California
Scripps Recruiting
La Jolla, California, United States, 92037
Contact: Heather Catchpole    858-554-5258    catchpole.heather@scrippshealth.org   
Principal Investigator: Richard A Schatz, MD         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Tracey S Early, BS, MA, CCRP    310-423-1231    tracey.early@cshs.org   
Principal Investigator: Timothy D Henry, MD         
Principal Investigator: Raj Makkar, MD         
United States, Florida
University of Florida - Shands Hospital Recruiting
Gainesville, Florida, United States, 32610
Contact: Sarah Long, RN    352-273-8932    sarah.long@medicine.ufl.edu   
Principal Investigator: Carl Pepine, MD         
United States, Illinois
Prairie Heart - St. John's Hospital Recruiting
Springfield, Illinois, United States, 62712
Contact: Lauren McNeil    217-492-9100 ext 142    lmcneil@prairieresearch.com   
Contact: Amy Woolfolk    217-492-9011 ext 152    awoolfolk@prairieresearch.com   
Principal Investigator: Frank Aguirre, MD         
United States, Indiana
St. Vincents Medical Group, Inc. Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Jill Gall, RN    317-586-2616    jmgall@stvincent.org   
Principal Investigator: James Hermiller, MD         
United States, Massachusetts
UMass Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Lori Thompson, RN    508-856-7385    lori.thompson@umassmed.edu   
Principal Investigator: Jeffrey Rade, MD         
United States, Minnesota
Metropolitan Heart and Vascular Institute / Mercy Hospital Recruiting
Cood Rapids, Minnesota, United States, 55433
Contact: Shelly Bloch, RN    763-236-9347    shelly.bloch@mhvi.com   
Contact: Bloch         
Principal Investigator: Jeffery Chambers, MD         
Minneapolis Heart Institute Foundation Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Jane Fox, RN, CCRC    612-863-6289    jane.fox@allina.com   
Principal Investigator: Jay Traverse, MD         
United States, Ohio
The Christ Hospital / Lindner Research Center Recruiting
Cincinnati, Ohio, United States, 45129
Contact: Ngoc (Teresa) Tran, RN, BSN    513-585-1777    LindnerMD@thechristhospital.com   
Contact: Tran         
Principal Investigator: Dean J Kereiakes, MD         
United States, Texas
Austin Heart Recruiting
Austin, Texas, United States, 78756
Contact: Janet Hatch       Janet.Hatch@HCAHealthcare.com   
Contact: Paige Musick       mailto:Paige.Musick@HCAHealthcare.com   
Principal Investigator: Roger Gammon, MD         
Sponsors and Collaborators
Capricor Inc.
Investigators
Study Director: Katherine A Beattie, BAN, CCRC Capricor Inc.
  More Information

No publications provided

Responsible Party: Capricor Inc.
ClinicalTrials.gov Identifier: NCT01458405     History of Changes
Other Study ID Numbers: 1002-01, RC3HL103356-01
Study First Received: October 20, 2011
Last Updated: July 14, 2014
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:
Myocardial Ischemia
Infarction
Myocardial Infarction
Ventricular Dysfunction, Left
Ventricular Dysfunction
Anterior Wall Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014