Angioblast CHF

Title:   Angioblast CHF – A Phase II Dose-escalation Study to Assess the Feasibility and Safety of Transendocardial Delivery of Three Different Doses of Allogeneic Mesenchymal Precursor Cells (MPCs)/Revascor™ in Subjects with Heart Failure.

Study Sponsor: Angioblast Systems, Inc   Principal Investigator: Timothy D. Henry, MD

Study Status: CLOSED TO ENROLLMENT

Study Synopsis: This study involves an investigational study procedure of injecting allogeneic (donor) stem cells into the heart muscle of people with heart failure to see if it may improve the function of their heart. Mesenchymal precursor cells (MPCs) are one type of stem cells produced from the bone marrow. Revascor™ is a special solution derived from adult bone marrow cells that are processed so they can be injected into the heart. Allogeneic means that the cells come from a donor and are not the study subject’s own cells. Research has shown that this type of cells will not likely be rejected when introduced into the body. When these special MPCs cells are injected into damaged heart muscle, they may improve heart muscle function.

The purpose of this study is to determine the safety and feasibility of injecting Revascor™ into the heart of patients with heart failure. The study will compare three different doses of Revascor™ versus placebo (no cells are injected) and  determine the effect of Revascor™ on heart structure and function.

A total of 60 subjects at up to 10 study sites will be asked to participate in this study. Your participation in this study is expected to last up to 3 years. The first year you will have testing done at specified times, and for the following 1½ to 3 years you will be contacted by telephone to see how you are feeling.

How do I qualify? We will consider patients with either ischemic (caused by blockages) or non-ischemic (no blockages or unknown cause) heart failure. Study specific screening tests are done to determine if you qualify.

Who do I contact for more information? Susan Jagger, RN BSN or contact research at 612.863.3980

Inclusion Criteria

1. NYHA ≥ 2.
2. Age >20 and <80.
3. Cardiomyopathy of ischemic or idiopathic etiology.
4. Subject is not a candidate for either percutaneous intervention or cardiac surgery as determined by both an interventional cardiologist and a cardiac surgeon.
5. LVEF < 40% via 2-D Echocardiogram within 28 days of study procedure.
6. On stable maximal, tolerable dosages of heart failure therapies including betablockers, ace inhibitors and/or diuretics with no interruption or change in medical therapy for at least 28 days prior to study enrollment.
7. LV wall thickness ≥ 8mm at target site by echo within 28 days of study procedure.
8. If the subject or partner is of childbearing potential, he or she must be willing to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening and for a period of at least 16 weeks after procedure.
9. Female subjects of childbearing potential must have a negative serum pregnancy test at screening.
10. Willing and able to understand, sign, and date the Informed Consent Form (ICF).
11. Must be willing to return for required follow-up visits.
12. Must be able to follow postoperative management program.

Exclusion Criteria

1. AMI in past 30 days.
2. Discharge of subject’s ICD within 28 days of study procedure.
3. Sustained VT as demonstrated by QRS complexes wider than 120 msec, lasting >3secs, and >100 bpm documented in screening ECG or 24 hour Holter monitoring..
4. Unstable angina.
5. LV thrombus by echocardiogram or angiogram with 28 days prior to and up to the time of cell injection.
6. Aortic stenosis as determined by echocardiography as valve area less than 1 cm2 that prohibits NOGA catheter access to LV.
7. Cardiogenic shock defined as the need for intravenous inotropic support, an intraaortic balloon pump, or mechanical circulatory support at the time of cell injections.
8. Chronic AF or AF at the time of cell injections.
9. Unprotected left main coronary artery disease >50%.
10. Ischemic or hemorrhagic stroke as diagnosed by CT/MRI events within the last 3 months prior to enrollment.
11. Bleeding diathesis disorder such as abnormal coagulation profile precluding performing of mapping/injection procedure.
12. Serum glucose level > 400 mg/dl within 28 days of study procedure.
13. Serum glucose level 300 to 400 mg/dl and presence of urine ketones within 28 days of study procedure.
14. Creatinine level ≥ 2.5 mg/dL within 28 days of study procedure.
15. Hematocrit ≤ 32% within 28 days of study procedure.
16. White Blood Cell count > 12 x 106/mm3 within 28 days of study procedure.
17. Platelet count ≤100 x106/mm3 within 28 days of study procedure.
18. Total bilirubin >3 mg/dL, albumin <2.8 g/dL, aspartate aminotransferase (AST) ≥ 2.5x the upper limit of normal, gamma glutamyltranspeptidase (GGT) ≥ 1.5x the upper limit of normal within 28 days of study procedure.
19. Presence of ≥ 20% anti-HLA antibody titers and/or having antibody specificities to donor HLA antigens.
20. A known hypersensitivity to dimethyl sulfoxide (DMSO), murine and/or bovine products.
21. History of cancer prior to screening (excluding basal cell carcinoma).
22. Acute or chronic infectious disease, including but not limited to human immunodeficiency virus (HIV).
23. Any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.
24. Treatment and/or an uncompleted follow-up treatment of any investigational. Therapy within 6 months before procedure and intent to participate in any other investigational drug or cell therapy study during the 3-year follow-up period of this study.
25. Active participation in other research therapy for cardiovascular repair/regeneration.
26. Prior recipient of stem precursor cell therapy for cardiac repair.