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History of Changes for Study: NCT01458405
Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration (ALLSTAR)
Latest version (submitted April 4, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 21, 2011 None (earliest Version on record)
2 July 10, 2012 Study Design, Study Status, Contacts/Locations, Outcome Measures, Study Identification, Eligibility, Arms and Interventions, Conditions, Study Description and Oversight
3 October 26, 2012 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 November 13, 2012 Contacts/Locations and Study Status
5 August 7, 2013 Contacts/Locations, Study Status and Eligibility
6 December 13, 2013 Contacts/Locations, Study Status and Eligibility
7 February 17, 2014 Contacts/Locations and Study Status
8 April 1, 2014 Contacts/Locations and Study Status
9 June 23, 2014 Contacts/Locations and Study Status
10 July 14, 2014 Contacts/Locations and Study Status
11 March 31, 2015 Contacts/Locations, Study Status and Eligibility
12 March 18, 2016 Contacts/Locations, Study Status, Eligibility, Study Design, Sponsor/Collaborators and Study Identification
13 June 8, 2016 Contacts/Locations and Study Status
14 September 9, 2016 Contacts/Locations, Study Status and Outcome Measures
15 September 13, 2016 Outcome Measures and Study Status
16 February 1, 2017 Recruitment Status, Study Status and Contacts/Locations
17 June 16, 2018 Study Status and Contacts/Locations
18 October 5, 2018 Study Status
19 October 8, 2018 Arms and Interventions and Study Status
20 April 4, 2019 Recruitment Status, Study Status, Study Design and Contacts/Locations
Comparison Format:

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Study NCT01458405
Submitted Date:  October 21, 2011 (v1)

Open or close this module Study Identification
Unique Protocol ID: ALLO CDC 001
Brief Title: Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration (ALLSTAR)
Official Title: Phase II Study of the Safety and Efficacy of Intracoronary Delivery of Cardiosphere-Derived Stem Cells in Patients With Ischemic Left Ventricular Dysfunction and a Recent Myocardial Infarction
Secondary IDs: RC3HL103356-01 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: October 2011
Overall Status: Not yet recruiting
Study Start:
Primary Completion:
Study Completion:
First Submitted: October 20, 2011
First Submitted that
Met QC Criteria:
October 21, 2011
First Posted: October 24, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 21, 2011
Last Update Posted: October 24, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Capricor Inc.
Responsible Party: Sponsor
Collaborators: National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study is to determine whether Allogeneic Cardiosphere-Derived Cells (CAP-1002) is effective in decreasing infarct size in patients with a recent myocardial infarction.
Detailed Description:
Open or close this module Conditions
Conditions: Myocardial Infarction
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model:
Number of Arms: 2
Masking: (masked roles unspecified)
Enrollment:
Open or close this module Arms and Interventions
Arms Assigned Interventions
Placebo Comparator: Placebo Biological: CAP-1002 Allogeneic Cardiosphere-Derived Cells
Active Comparator: CAP-1002 Allogeneic Cardiosphere-Derived Cells Biological: CAP-1002 Allogeneic Cardiosphere-Derived Cells
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Infarct size assessed by MRI
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Myocardial infarction due to coronary artery atherosclerotic disease and evidenced by typical ischemic symptoms, serial ST-T or Q wave ECG changes, and serum troponin I rise to > 99th percentile of the upper reference limit within 12 weeks of enrollment with at least one of the following: symptoms of ischemia, ECG changes indicative of new ischemia (new ST-T changes or new left bundle branch block), development of pathological Q waves on the ECG, imaging evidence of new loss of viable myocardium, or new regional wall motion abnormalities.
  2. Prescreening left ventricular ejection fraction of ≥ 0.25 and ≤ 0.40 as determined by clinically-indicated assessment of cardiac function (echo, gated blood pool scan, x-ray contrast ventriculography, CT and/or MRI) one day or more following successful reperfusion.
  3. An area of regional dysfunction, i.e. hypokinetic, akinetic, or dyskinetic, as assessed by echocardiography, left ventriculography, or MRI.
  4. History of angioplasty and stent placement, with resultant TIMI flow > 2, in the artery supplying the infarcted, dysfunctional territory and through which the CDCs will be infused.
  5. Left ventricular ejection fraction of ≥ 0.25 and ≤ 0.45 and infarct size of ≥ 17% of left ventricular mass as determined by screening MRI.
  6. No further revascularization clinically indicated at the time the patient is assessed for participation in the clinical trial. This will be determined by a cardiologist who is not an investigator in the clinical trial. No further revascularization may be indicated by no arteries with a significant stenosis, the location and extent of any stenosis may not be suitable for angioplasty, the distal vessels may not be suitable for placement of bypass grafts, and/or the patient declines angioplasty or bypass surgery.
  7. Ability to provide informed consent and follow-up with protocol procedures.
  8. Age > 18 years.

Exclusion Criteria:

  1. Measurable anti-HLA antibody levels (PRA > 0%).
  2. Diagnosed or suspected myocarditis.
  3. History of cardiac tumor, or cardiac tumor demonstrated on baseline MRI.
  4. Contraindications to MRI, including prior ICD placement, estimated glomerular filtration rate < 50 mL/min (or GFR <30 mL/min during a prior protocol-mandated MRI study), known reaction to gadolinium, claustrophobia, pacemaker, ear implant, and cochlear implant. History of possible presence of ferromagnetic material including programmable shunt, shrapnel, penile prosthesis, intra-uterine device, bullets, tattoos, artificial limb, blood vessel coil, and tissue expander may require special screening.
  5. Non-cardiovascular disease with expected life expectancy of < 3 years.
  6. Requirement for chronic immunosuppressive therapy.
  7. Participation in an on-going protocol studying an experimental drug or device.
  8. Diagnosis of right ventricular arrhythmogenic cardiomyopathy.
  9. Patients with occlusion or > 50% stenosis of the infarct-related artery at screening or before administration of CDCs.
  10. Current alcohol or drug abuse because of anticipated difficulty in complying with protocol-related procedures.
  11. Pregnant or child-bearing potential without use of effective contraception. Men intending to "father" children are also excluded.
  12. Human Immunodeficiency Virus infection.
  13. Viral hepatitis.
  14. Uncontrolled diabetes and/or hemoglobin A1C > 8.5%.
  15. Abnormal liver function (SGPT > 3 times the upper reference range) and/or hematology (hematocrit < 25%, WBC < 3000, platelets < 100,000) studies without a reversible, identifiable cause.
  16. Sustained ventricular tachycardia not associated with the index myocardial infarction (> 48 hours after the MI onset) or a new acute ischemic episode.
  17. Non-sustained ventricular tachycardia > 10 seconds not associated with the index myocardial infarction (> 48 hours after the MI onset) or a new acute ischemic episode.
  18. Ventricular fibrillation not associated with a new acute ischemic episode.
  19. Symptomatic ventricular tachyarrhythmia complicating the index myocardial infarction.
  20. New York Heart Association Class 4 congestive heart failure.
  21. Canadian Cardiovascular Society Angina Class 3 or 4.
  22. Inability to rule out cancer based on screening chest/abdominal/pelvic (body) CT scan.
  23. Any prior transplant.
  24. Known hypersensitivity to dimethyl sulfoxide (DMSO).
Open or close this module Contacts/Locations
Study Officials: Rachel Smith, PhD
Study Director
Capricor Inc.
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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