View Clinical Trial (Medical Research Study)
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)in Subjects With Heart Failure - NCT00721045-77030(Clinical Trial 233091)
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Houston |
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State:
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TX |
| Zip Code: |
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77030 |
| Conditions: |
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Heart Failure |
| Purpose: |
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This is a dose-ranging clinical study to evaluate the feasibility, safety, and tolerability
of 3 different doses of immunoselected, culture expanded, nucleated, allogeneic MPCs in
subjects who have cardiomyopathy of both ischemic and idiopathic etiology.
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| Study summary: |
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Heart failure subjects recruited will include those who have advanced heart failure NYHA
class II to IV and a depressed ejection fraction (EF < 40%). Baseline eligibility testing
assessments will be completed within 28 days prior to cell delivery. Efficacy will be
explored at 3, 6, and 12 months.
This will be a single-blinded, dose-escalation, cohort study in 60 subjects allocated
sequentially to 1 of 3 cohorts A, B, or C. Forty-five subjects will be randomized to receive
transendocardial delivery of MPC treatment, and 15 subjects will be randomized to receive
standard-of-care treatment without MPC administration. The fifteen subjects randomized to
receive standard of care without needle injection will serve as the study's control
population and will undergo mock mapping and verbal injection scripts. |
| Criteria: |
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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 >30 secs,
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. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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