- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02503280
The Transendocardial Autologous Cells (hMSC) or (hMSC) and (hCSC) in Ischemic Heart Failure Trial. (TAC-HFT-II)
A Phase I/II, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Transendocardial Injection of Autologous Human Cells (Mesenchymal or the Combination of MSC and Cardiac Stem Cells) in Patients With Chronic Ischemic Left Ventricular Dysfunction and Heart Failure Secondary to Myocardial Infarction.
Before initiating the full randomized study, a Pilot Safety Phase will be performed. In this phase the composition of cells administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested. The randomized portion of the study will be conducted after a full review of the safety data from the pilot Phase by the Data safety monitoring board.
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.
Study Overview
Status
Detailed Description
A Phase I/II, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Transendocardial Injection of Autologous Human Cells (Mesenchymal or the combination of MSC and Cardiac Stem Cells) in Patients With Chronic Ischemic Left Ventricular Dysfunction and Heart Failure Secondary to Myocardial Infarction.
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.
Study Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Florida
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Miami, Florida, United States, 33136
- ISCI / University of Miami
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
In order to participate in this study, a patient MUST:
- Be ≥ 21 and < 90 years of age.
- Provide written informed consent.
- 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.
- 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.
- Be a candidate for cardiac catheterization.
- 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:
In order to participate in this study, a patient MUST NOT:
- Have a baseline glomerular filtration rate < 50 ml/min1.73m2.
- Have a known, serious radiographic contrast allergy.
- Have a mechanical aortic valve or heart constrictive device.
- Have a documented presence of aortic stenosis (aortic stenosis graded as ≥ +2 equivalent to an orifice area of 1.5cm2 or less).
- Have a documented presence of moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥+2).
- 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.
- Evidence of a life-threatening arrhythmia (nonsustained ventricular tachycardia ≥ 20 consecutive beats or complete heart block) or QTc interval > 550 ms on screening ECG.
- AICD firing in the past 60 days prior to the procedure.
- Have unstable angina within 2 weeks of the planned procedure.
- Have a hematologic abnormality as evidenced by hematocrit < 25%, white blood cell < 2,500/ul or platelet values < 100,000/ul without another explanation.
- Have liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the ULN.
- 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
- Have known allergies to penicillin or streptomycin.
- Have a contra-indication to performance of an MRI scan.
- Be an organ transplant recipient.
- 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.
- Have a non-cardiac condition that limits lifespan to < 1 year.
- Have a history of drug or alcohol abuse within the past 24 months.
- Be on chronic therapy with immunosuppressant medication, such as corticosteroids or TNFα antagonists.
- Be serum positive for HIV, hepatitis BsAg or hepatitis C.
- Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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: 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.
Other Names:
Biosense Webster MyoStar NOGA Injection Catheter System will be used to administer the study drug
Other Names:
|
Experimental: 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.
|
Biosense Webster MyoStar NOGA Injection Catheter System will be used to administer the study drug
Other Names:
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.
Other Names:
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Placebo Comparator: 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.
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Biosense Webster MyoStar NOGA Injection Catheter System will be used to administer the study drug
Other Names:
Placebo (ten 0.5 ml injections of phosphate-buffered saline [PBS] and 1% human serum albumin [HSA]).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of any treatment emergent serious adverse events (TE-SAEs)
Time Frame: One Month post-catheterization
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Incidence (at one month post-catheterization) of any treatment-emergent serious adverse events (TE-SAEs), defined as the composite of: death, non-fatal MI, stroke, hospitalization for worsening heart failure, cardiac perforation, pericardial tamponade, sustained ventricular arrhythmias (characterized by ventricular arrhythmias lasting longer than 15 seconds or with hemodynamic compromise), or atrial fibrillation.
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One Month post-catheterization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Emergent adverse event rates
Time Frame: At 6 Month and 12 Month visit
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Rate of adverse events occurring ad
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At 6 Month and 12 Month visit
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Ectopic tissue formation
Time Frame: At 6 Month and 12 Month visit
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Ectopic tissue formation (as identified from MRI scans of the chest, abdomen, & pelvis).
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At 6 Month and 12 Month visit
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48-hour ambulatory electrocardiogram (ECG) recordings.
Time Frame: At 6 Month and 12 Month visit
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Electrocardiogram (ECG) recordings measured over 48 Hours
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At 6 Month and 12 Month visit
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Hematology value changes post-catheterization
Time Frame: At 6 Month and 12 Month visit
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Hematology value changes will be observed at the 6 month and 12 month visit post-catheterization.
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At 6 Month and 12 Month visit
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Urinalysis results changes post-catheterization
Time Frame: At 6 Month and 12 Month visit
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Urinalysis results changes will be observed at the 6 month and 12 month visit post-catheterization.
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At 6 Month and 12 Month visit
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Clinical chemistry values post-catheterization
Time Frame: At 6 Month and 12 Month visit
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Clinical chemistry value changes will be observed at the 6 month and 12 month visit post-catheterization.
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At 6 Month and 12 Month visit
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Pulmonary function
Time Frame: At 6 Month and 12 Month visit
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Pulmonary function - forced expiratory volume in 1 second (FEV1) results.
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At 6 Month and 12 Month visit
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Serial troponin I values
Time Frame: Every 12 hours for the first 48 hours post-cardiac catheterization
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Serial troponin I values (every 12 hours for first 48 hours post-cardiac catheterization).
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Every 12 hours for the first 48 hours post-cardiac catheterization
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Creatine kinase-MB (CK-MB) value changes post-catheterization
Time Frame: Every 12 hours for first 48 hours post-cardiac catheterization
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CK-MB values (every 12 hours for first 48 hours post-cardiac catheterization).
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Every 12 hours for first 48 hours post-cardiac catheterization
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Post-cardiac catheterization echocardiogram.
Time Frame: Day 1 Post Echocardiogram
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Echocardiogram performed after cardiac catheterization
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Day 1 Post Echocardiogram
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Magnetic resonance imaging (MRI) measures of infarct scar size (ISS)
Time Frame: At 6 Month and 12 Month visit
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Document Infarct Scar Size (ISS) via Magnetic Resonance imaging (MRI)
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At 6 Month and 12 Month visit
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Echocardiographic measures of infarct scar size (ISS)
Time Frame: At 6 Month and 12 Month visit
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Document Infarct Scar Size (ISS) via echocardiographic procedure
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At 6 Month and 12 Month visit
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Magnetic resonance imaging (MRI) of Left Regional Ventricular Function
Time Frame: At 6 Month and 12 Month visit
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Document Left Regional Ventricular Function via Magnetic Resonance imaging (MRI)
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At 6 Month and 12 Month visit
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Echocardiographic measures of Left Regional Ventricular Function
Time Frame: At 6 Month and 12 Month visit
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Document Left Regional Ventricular Function via echocardiographic procedure
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At 6 Month and 12 Month visit
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Magnetic resonance imaging (MRI) of Global Ventricular Function
Time Frame: At 6 Month and 12 Month visit
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Document Global Ventricular Function via Magnetic Resonance imaging (MRI)
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At 6 Month and 12 Month visit
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Echocardiographic measures of Global Ventricular Function
Time Frame: At 6 Month and 12 Month visit
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Document Global Ventricular Function via echocardiographic procedure
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At 6 Month and 12 Month visit
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Tissue perfusion measured by MRI.
Time Frame: At 6 Month and 12 Month visit
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Measure Tissue Perfusion via Magnetic Resonance imaging (MRI)
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At 6 Month and 12 Month visit
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Peak oxygen consumption (Peak VO2) (by treadmill determination).
Time Frame: At 6 Month and 12 Month visit
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Peak VO2 Oxygen Consumption determined by utilizing treadmill
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At 6 Month and 12 Month visit
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Six-minute walk test.
Time Frame: At 6 Month and 12 Month visit
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Evaluate Functional Capacity via the Six Minute Walk Test
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At 6 Month and 12 Month visit
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New York Heart Association (NYHA) functional class.
Time Frame: At 6 Month and 12 Month visit
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Evaluate Functional Capacity via New York Heart Association (NYHA) Class Determination
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At 6 Month and 12 Month visit
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Minnesota Living with Heart Failure (MLHF) questionnaire.
Time Frame: At 6 Month and 12 Month visit
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Evaluate Quality Of Life Changes via Minnesota Living with Heart Failure (MLHF) Questionnaire
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At 6 Month and 12 Month visit
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Incidence of Major Adverse Cardiac Events (MACE)
Time Frame: At 6 Month and 12 Month visit
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Incidence of Major Adverse Cardiac Events (MACE), defined as the composite incidence of (1) death, (2) hospitalization for worsening HF, or (3) non-fatal recurrent MI.
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At 6 Month and 12 Month visit
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20120203
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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