The Transendocardial Autologous Cells (hMSC) or (hMSC) and (hCSC) in Ischemic Heart Failure Trial.
NCT ID: NCT02503280
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2025-03-01
2032-03-31
Brief Summary
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Following the Pilot Phase of five (5) Fifty (50) patients scheduled to undergo cardiac catheterization and meeting all inclusion/exclusion criteria will be evaluated at baseline.
Patients will be randomized in a 2:2:1 ratio to one of three Treatment Strategies.
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Detailed Description
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A total of 55 subjects participating, with 5 in the pilot phase and 50 in the randomized phase.
Patients with chronic ischemic left ventricular dysfunction and heart failure secondary to MI scheduled to undergo cardiac catheterization.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A - Autologous hMSCs
Autologous hMSCs: 40 million cells/ml delivered in 0.5 ml injection volumes times 10 injections for a total of 2 x 10\^8 (200 million) hMSCs. The Biosense Webster MyoStar NOGA Injection Catheter System will be used in the delivery of the study drug.
Autologous hMSCs
Autologous hMSCs: 40 million cells/ml delivered in 0.5 ml injection volumes times 10 injections for a total of 2 x 10\^8 (200 million) hMSCs.
Biosense Webster MyoStar NOGA Injection Catheter System
Biosense Webster MyoStar NOGA Injection Catheter System will be used to administer the study drug
Group B - Autologous Human C-Kit CSCs II
Autologous hMSCs PLUS autologous C-Kit hCSCs: Mixture of 39.8 million hMSCs and 0.2 million C-Kit hCSCs/ml delivered in 0.5 ml injection volumes times 10 injections for a total of 1.99 x 10\^8 (199 million) hMSCs and 1 million C-Kit hCSCs.The Biosense Webster MyoStar NOGA Injection Catheter System will be used in the delivery of the study drug.
Autologous Human C-Kit CSCs II
Autologous hMSCs PLUS autologous C-Kit hCSCs: Mixture of 39.8 million hMSCs and 0.2 million C-Kit hCSCs/ml delivered in 0.5 ml injection volumes times 10 injections for a total of 1.99 x 10\^8 (199 million) hMSCs and 1 million C-Kit hCSCs.
Biosense Webster MyoStar NOGA Injection Catheter System
Biosense Webster MyoStar NOGA Injection Catheter System will be used to administer the study drug
Placebo
Placebo (ten 0.5 ml injections of phosphate-buffered saline \[PBS\] and 1% human serum albumin \[HSA\]).The Biosense Webster MyoStar NOGA Injection Catheter System will be used in the delivery of the study drug.
Placebo
Placebo (ten 0.5 ml injections of phosphate-buffered saline \[PBS\] and 1% human serum albumin \[HSA\]).
Biosense Webster MyoStar NOGA Injection Catheter System
Biosense Webster MyoStar NOGA Injection Catheter System will be used to administer the study drug
Interventions
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Autologous hMSCs
Autologous hMSCs: 40 million cells/ml delivered in 0.5 ml injection volumes times 10 injections for a total of 2 x 10\^8 (200 million) hMSCs.
Autologous Human C-Kit CSCs II
Autologous hMSCs PLUS autologous C-Kit hCSCs: Mixture of 39.8 million hMSCs and 0.2 million C-Kit hCSCs/ml delivered in 0.5 ml injection volumes times 10 injections for a total of 1.99 x 10\^8 (199 million) hMSCs and 1 million C-Kit hCSCs.
Placebo
Placebo (ten 0.5 ml injections of phosphate-buffered saline \[PBS\] and 1% human serum albumin \[HSA\]).
Biosense Webster MyoStar NOGA Injection Catheter System
Biosense Webster MyoStar NOGA Injection Catheter System will be used to administer the study drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Be ≥ 21 and \< 90 years of age.
2. Provide written informed consent.
3. Have a diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI) as defined by the following: Screening MRI must show an area of akinesis, dyskinesis, or severe hypokinesis associated with evidence of myocardial scarring based on delayed hyperenhancement following gadolinium infusion.
4. Been treated with appropriate maximal medical therapy for heart failure or post-infarction left ventricular dysfunction. For beta-blockade, the patient must have been on a stable dose of a clinically appropriate beta-blocker for 3 months. For angiotensin-converting enzyme inhibition, the patient must have been on a stable dose of a clinically appropriate agent for 1 month.
5. Be a candidate for cardiac catheterization.
6. Have an ejection fraction ≤ 50% by gated blood pool scan, two-dimensional echocardiogram, cardiac MRI, or left ventriculogram within the prior six months and not in the setting of a recent ischemic event.
Exclusion Criteria
1. Have a baseline glomerular filtration rate \< 50 ml/min1.73m2.
2. Have a known, serious radiographic contrast allergy.
3. Have a mechanical aortic valve or heart constrictive device.
4. Have a documented presence of aortic stenosis (aortic stenosis graded as ≥ +2 equivalent to an orifice area of 1.5cm2 or less).
5. Have a documented presence of moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥+2).
6. Require coronary artery revascularization. Patients who require or undergo revascularization procedures should undergo these procedures a minimum of 3 months in advance of treatment within this study. In addition, patients who develop a need for revascularization following enrollment will be submitted for this therapy without delay.
7. Evidence of a life-threatening arrhythmia (nonsustained ventricular tachycardia ≥ 20 consecutive beats or complete heart block) or QTc interval \> 550 ms on screening ECG.
8. AICD firing in the past 60 days prior to the procedure.
9. Have unstable angina within 2 weeks of the planned procedure.
10. Have a hematologic abnormality as evidenced by hematocrit \< 25%, white blood cell \< 2,500/ul or platelet values \< 100,000/ul without another explanation.
11. Have liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the ULN.
12. Have a coagulopathy = (INR \> 1.3) not due to a reversible cause (i.e., Coumadin). Patients on Coumadin will be withdrawn 5 days before the procedure and confirmed to have an INR \< 1.3. Patients who cannot be withdrawn from Coumadin will be excluded from enrollment
13. Have known allergies to penicillin or streptomycin.
14. Have a contra-indication to performance of an MRI scan.
15. Be an organ transplant recipient.
16. Have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma.
17. Have a non-cardiac condition that limits lifespan to \< 1 year.
18. Have a history of drug or alcohol abuse within the past 24 months.
19. Be on chronic therapy with immunosuppressant medication, such as corticosteroids or TNFα antagonists.
20. Be serum positive for HIV, hepatitis BsAg or hepatitis C.
21. Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.
22. Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female patients must undergo a blood or urine pregnancy test at screening and within 36 hours prior to injection.
21 Years
89 Years
ALL
No
Sponsors
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Joshua M Hare
OTHER
Responsible Party
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Joshua M Hare
ISCI Director, Chief Science Officer, Senior Assoc. Dean, Louis Lemberg Professor of Medicine
Principal Investigators
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Joshua M Hare, MD
Role: PRINCIPAL_INVESTIGATOR
ISCI / University of Miami Miller School of Medicine
Locations
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ISCI / University of Miami
Miami, Florida, United States
Countries
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Related Links
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Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine
Other Identifiers
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20120203
Identifier Type: -
Identifier Source: org_study_id
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