Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:10/12/2018
Start Date:November 13, 2012
End Date:July 2, 2021

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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 a 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.


Inclusion Criteria

1. 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 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.

2. History of percutaneous coronary intervention (PCI), with stent placement resulting in
TIMI flow = 3, in the coronary artery supplying the infarcted, dysfunctional territory
and through which the treatment will be infused.

3. 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 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 the most recent test prior to or during the screening period.

- For subjects 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: 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 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.

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 patent graft
(arterial or saphenous vein graft) attached to the coronary artery to be infused.

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 ICD and/or pacemaker placement where study imaging site has not been trained and
certified specifically for this protocol to conduct cardiac MRI in subjects 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.

10. Estimated glomerular filtration rate < 30 mL/min.

11. Participation in an on-going 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.

14. 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).

15. Human Immunodeficiency Virus (HIV) infection.

16. Viral hepatitis.

17. Uncontrolled diabetes (HbA1c>9%).

18. Abnormal liver function (SGPT/ALT > 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.
We found this trial at
32
sites
Huntsville, Alabama 35801
Principal Investigator: Alejandro Vasquez, MD
Phone: 256-519-8285
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Timothy D Henry, MD
Phone: 310-423-1231
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Saurabh Gupta, MD
Phone: 503-494-2004
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Amit Patel, MD
University of Utah Research is a major component in the life of the U benefiting...
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Creighton W Don, MD
Phone: 206-616-6768
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Akron, Ohio 44304
Principal Investigator: Kevin Silver, MD
Phone: 330-253-8195
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Austin, Texas 78756
Principal Investigator: Roger Gammon, MD
Phone: 512-206-3603
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Birmingham, Alabama 35211
Principal Investigator: Farrell Mendelsohn, MD
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Buffalo, New York 14215
Principal Investigator: Vijay Iyer, MD
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Burlington, Vermont 05405
Principal Investigator: Matthew Watkins, MD
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Charlotte, North Carolina 28203
Principal Investigator: Glen Kowalchuk, MD
Phone: 704-355-4794
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Gary Schaer, MD
Phone: 312-942-8239
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Cincinnati, Ohio 45219
Principal Investigator: Dean Kereiakes, MD
Phone: 513-585-1777
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Vincent Pompili, MD
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Columbus, Ohio 43214
Principal Investigator: Carlos Sanchez, MD
Phone: 614-566-5768
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Durham, North Carolina 27705
Principal Investigator: Thomas Povsic, MD
Phone: 919-681-3821
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Gainesville, Florida 32608
Principal Investigator: Carl Pepine, MD
Phone: 352-273-8932
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Houston, Texas 77030
Principal Investigator: H. Vernon Anderson, MD
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Kansas City, Kansas
Principal Investigator: Buddhadeb Dawn, MD
Phone: 913-588-5687
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La Jolla, California 92037
Principal Investigator: Richard A Schatz, MD
Phone: 858-554-5258
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Lexington, Kentucky
859) 257-9000
Principal Investigator: Ahmed Abdel-Latif, MD
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Milwaukee, Wisconsin 53215
Principal Investigator: Tanvir Bajwa, MD
Phone: 414-649-3490
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Minneapolis, Minnesota 55407
Principal Investigator: Jay Traverse, MD
Phone: 612-863-6289
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New York, New York 10021
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Catalin Toma, MD
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164 Summit Ave
Providence, Rhode Island 02906
(401) 793-2500
Principal Investigator: Paul Gordon, MD
Phone: 401-793-5554
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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Raleigh, North Carolina 27610
Principal Investigator: James Zidar, MD
Phone: 919-757-5380
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Saginaw, Michigan 48601
Principal Investigator: Safwan Kassas, MD
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Seattle, Washington 98122
Principal Investigator: Paul Huang, MD
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Springfield, Illinois 62712
Principal Investigator: Frank Aguirre, MD
Phone: 217-492-9100
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Worcester, Massachusetts 01605
Principal Investigator: Jeffrey Rade, MD
Phone: 508-856-5094
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