Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure (CONCERT-HF)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02501811 |
Recruitment Status :
Completed
First Posted : July 17, 2015
Last Update Posted : October 27, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ischemic Cardiomyopathy | Biological: Mesenchymal Stem Cells (MSC) Biological: c-kit+ cells Biological: Placebo (Plasmalyte A) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 125 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase II, Randomized, Placebo-Controlled Study of the Safety, Feasibility, and Efficacy of Autologous Mesenchymal Stem Cells and C-kit+ Cardiac Stem Cells, Alone or in Combination, Administered Transendocardially in Subjects With Ischemic Heart Failure |
Study Start Date : | October 2015 |
Actual Primary Completion Date : | June 25, 2020 |
Actual Study Completion Date : | July 22, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Mesenchymal Stem Cells (MSC)
Target dose of 150 million MSCs
|
Biological: Mesenchymal Stem Cells (MSC)
15 transendocardial injections of 0.4ml MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure) |
Experimental: c-kit+ cells
Target dose of 5 million c-kit+ cells
|
Biological: c-kit+ cells
15 transendocardial injections of 0.4ml c-kit+ cells administered to the left ventricle via NOGA Myostar injection catheter (single procedure) |
Experimental: Combination Cells (MSC and c-kit+ cells)
Target dose of 150 million MSCs and 5 million c-kit+ cells
|
Biological: Mesenchymal Stem Cells (MSC)
15 transendocardial injections of 0.4ml MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure) Biological: c-kit+ cells 15 transendocardial injections of 0.4ml c-kit+ cells administered to the left ventricle via NOGA Myostar injection catheter (single procedure) |
Placebo Comparator: Placebo (Plasmalyte A)
Plasmalyte A
|
Biological: Placebo (Plasmalyte A)
15 transendocardial injections of 0.4ml placebo administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
Other Name: Plasmalyte A |
- Left Ventricular Ejection Fraction (LVEF) [ Time Frame: Assessed as a trajectory (baseline, 6 months, and 12 months) ]Change in left ventricular ejection fraction as assessed via cardiac MRI
- Left Ventricular Ejection Fraction (LVEF) [ Time Frame: Baseline to 6 months ]Change in left ventricular ejection fraction as assessed via cardiac MRI
- Left Ventricular Ejection Fraction (LVEF) [ Time Frame: Baseline to 12 months ]Change in left ventricular ejection fraction as assessed via cardiac MRI
- Global Strain (HARP MRI) [ Time Frame: Assessed as a trajectory (baseline, 6 months, and 12 months) ]Change in global circumferential strain as assessed via cardiac MRI
- Global Strain (HARP MRI) [ Time Frame: Baseline to 6 months ]Change in global circumferential strain as assessed via cardiac MRI
- Global Strain (HARP MRI) [ Time Frame: Baseline to 12 months ]Change in global circumferential strain as assessed via cardiac MRI
- Regional Strain (HARP MRI) [ Time Frame: Assessed as a trajectory (baseline, 6 months, and 12 months) ]Change in regional longitudinal strain as assessed via cardiac MRI
- Regional Strain (HARP MRI) [ Time Frame: Baseline to 6 months ]Change in regional longitudinal strain as assessed via cardiac MRI
- Regional Strain (HARP MRI) [ Time Frame: Baseline to 12 months ]Change in regional longitudinal strain as assessed via cardiac MRI
- Left Ventricular End Diastolic Volume Index (LVEDVI) [ Time Frame: Assessed as a trajectory (baseline, 6 months, and 12 months) ]Change in left ventricular end diastolic volume index as measured via cardiac MRI
- Left Ventricular End Diastolic Volume Index (LVEDVI) [ Time Frame: Baseline to 6 months ]Change in left ventricular end diastolic volume index as measured via cardiac MRI
- Left Ventricular End Diastolic Volume Index (LVEDVI) [ Time Frame: Baseline to 12 months ]Change in left ventricular end diastolic volume index as measured via cardiac MRI
- Left Ventricular End Systolic Volume Index (LVESVI) [ Time Frame: Assessed as a trajectory (baseline, 6 months, 12 months) ]Change in left ventricular end systolic volume index as assessed via cardiac MRI
- Left Ventricular End Systolic Volume Index (LVESVI) [ Time Frame: Baseline to 6 months ]Change in left ventricular end systolic volume index as assessed via cardiac MRI
- Left Ventricular End Systolic Volume Index (LVESVI) [ Time Frame: Baseline to 12 months ]Change in left ventricular end systolic volume index as assessed via cardiac MRI
- Left Ventricular Sphericity Index [ Time Frame: Assessed as a trajectory (baseline, 6 months, and 12 months) ]Change in left ventricular sphericity as assessed via cardiac MRI
- Left Ventricular Sphericity Index [ Time Frame: Baseline to 6 months ]Change in left ventricular sphericity as assessed via cardiac MRI
- Left Ventricular Sphericity Index [ Time Frame: Baseline to 12 months ]Change in left ventricular sphericity as assessed via cardiac MRI
- Infarct/scar Volume (DEMRI) [ Time Frame: Assessed as a trajectory (baseline, 6 months, and 12 months) ]Change in infarct/scar volume as assessed via cardiac MRI
- Infarct/scar Volume (DEMRI) [ Time Frame: Baseline to 6 months ]Change in infarct/scar volume as assessed via cardiac MRI
- Infarct/scar Volume (DEMRI) [ Time Frame: Baseline to 12 months ]Change in infarct/scar volume as assessed via cardiac MRI
- Maximal Oxygen Consumption (VO2 max) [ Time Frame: Assessed as a trajectory (baseline, 6 months, and 12 months) ]Change in maximal oxygen consumption (V02 max) as assessed via treadmill
- Maximal Oxygen Consumption (VO2 max) [ Time Frame: Baseline to 6 months ]Change in maximal oxygen consumption (V02 max) as assessed via treadmill
- Maximal Oxygen Consumption (VO2 max) [ Time Frame: Baseline to 12 months ]Change in maximal oxygen consumption (V02 max) as assessed via treadmill
- Exercise Tolerance [ Time Frame: Assessed as a trajectory (baseline, 6 months, and 12 months) ]Change in exercise tolerance as assessed via the 6 minute walk test
- Exercise Tolerance [ Time Frame: Baseline to 6 months ]Change in exercise tolerance as assessed via the 6 minute walk test
- Exercise Tolerance [ Time Frame: Baseline to 12 months ]Change in exercise tolerance as assessed via the 6 minute walk test
- Minnesota Living with Heart Failure Questionnaire (MHLFQ) Score [ Time Frame: Assessed as a trajectory (baseline, 6 months, and 12 months) ]Change in Minnesota Living with Heart Failure Questionnaire (MHLFQ) score
- Minnesota Living with Heart Failure Questionnaire (MHLFQ) Score [ Time Frame: Baseline to 6 months ]Change in Minnesota Living with Heart Failure Questionnaire (MHLFQ) score
- Minnesota Living with Heart Failure Questionnaire (MHLFQ) Score [ Time Frame: Baseline to 12 months ]Change in Minnesota Living with Heart Failure Questionnaire (MHLFQ) score
- N-Terminal pro-Brain Natriuretic Peptide (NT-proBNP) [ Time Frame: Assessed as a trajectory (baseline, 6 months, and 12 months) ]Change in N-Terminal pro-Brain Natriuretic Peptide (NT-proBNP) as measured via blood draw
- N-Terminal pro-Brain Natriuretic Peptide (NT-proBNP) [ Time Frame: Baseline to 6 months ]Change in N-Terminal pro-Brain Natriuretic Peptide (NT-proBNP) as measured via blood draw
- N-Terminal pro-Brain Natriuretic Peptide (NT-proBNP) [ Time Frame: Baseline to 12 months ]Change in N-Terminal pro-Brain Natriuretic Peptide (NT-proBNP) as measured via blood draw
- Incidence of major adverse cardiac events (MACE) [ Time Frame: Baseline to 6 months ]Incidence of adjudicated events including death, hospitalization for worsening heart failure, and/or other exacerbation of heart failure (non-hospitalization)
- Incidence of major adverse cardiac events (MACE) [ Time Frame: Baseline to 12 months ]Incidence of adjudicated events including death, hospitalization for worsening heart failure, and/or other exacerbation of heart failure (non-hospitalization)
- Incidence of other significant clinical events [ Time Frame: Baseline to 6 months ]Incidence of other significant adjudicated clinical events including: non-fatal stroke, non-fatal MI, coronary artery revascularization, ventricular tachycardia/fibrillation, and pericardial tamponade
- Incidence of other significant clinical events [ Time Frame: Baseline to 12 months ]Incidence of other significant adjudicated clinical events including: non-fatal stroke, non-fatal MI, coronary artery revascularization, ventricular tachycardia/fibrillation, and pericardial tamponade
- Cumulative Days alive and out of hospital for heart failure [ Time Frame: Baseline to 12 months ]Days alive and out of hospital during the study evaluation period
- Subjects with events between randomization and study product injection (SPI) that preclude the receipt of product [ Time Frame: Randomization to SPI ]Number and percent of subjects with events between randomization and study product injection (SPI) that preclude the subject from receiving product.
- Subjects who have a failed bone marrow aspiration procedure [ Time Frame: During bone marrow aspiration procedure ]Number and percent of subjects who do not successfully undergo bone marrow aspiration
- Subjects who have a failed endomyocardial biopsy procedure [ Time Frame: During endomyocardial biopsy procedure ]Number and percent of subjects who do not successfully undergo endomyocardial biopsy procedure
- Subject MSC products which failed release criteria [ Time Frame: Harvest to Study Product Injection Procedure ]Number and percent of subjects who have MSC products which failed release criteria
- Subject c-kit+ products which failed release criteria [ Time Frame: Harvest to SPI procedure ]Number and percent of subjects who have c-kit+ products which failed release criteria
- Subjects who receive less than 15 injections during SPI [ Time Frame: During SPI procedure ]Number and percent of subjects who received less than 15 injections during SPI
- Subjects who have at least one cardiac MRI endpoint measure that is uninterpretable [ Time Frame: Baseline to 12 months ]Number and percent of subjects who have at least one cardiac MRI endpoint measure that is uninterpretable due to issues related to the device, including, but not limited to, inability to undergo the procedure

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years to 79 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Be ≥ 21 and <80 years of age
- Have documented coronary artery disease (CAD) with evidence of myocardial injury, LV dysfunction, and clinical evidence of HF
- Have a "detectable" area of myocardial injury defined as ≥ 5% LV involvement (infarct volume) and any subendocardial involvement by cMRI
- Have an EF ≤ 40% by cMRI
- Be receiving guideline-driven medical therapy for heart failure at stable and tolerated doses for ≥ 1 month prior to consent. For beta-blockade "stable" is defined as no greater than a 50% reduction in dose or no more than a 100% increase in dose.
- Be a candidate for cardiac catheterization
- Have NYHA class I, II, or III heart failure symptoms
- If a female of childbearing potential, be willing to use one form of birth control for the duration of the study, and undergo a pregnancy test at baseline and within 36 hours prior to injection
Exclusion Criteria:
- Indication for standard-of-care surgery (including valve surgery, placement of left-ventricular assist device, or imminent heart transplantation), coronary artery bypass grafting (CABG) procedure, and/or percutaneous coronary intervention (PCI) for the treatment of ischemic and/or valvular heart disease. Subjects who require or undergo PCI should undergo these procedures a minimum of 3 months in advance of randomization. Subjects who require or undergo CABG should undergo these procedures a minimum of 4 months in advance of randomization. In addition, subjects who develop a need for revascularization following enrollment should undergo revascularization without delay. Indication for imminent heart transplantation is defined as a high likelihood of transplant prior to collection of the 12 month study endpoint. Candidates cannot be UNOS status 1A or 1B, and they must have documented low probability of being transplanted
- Valvular heart disease including 1) mechanical or bioprosthetic heart valve; or 2) severe (any valve) insufficiency/regurgitation within 12 months of consent
- Aortic stenosis with valve area ≤ 1.5 cm2
- History of ischemic or hemorrhagic stroke within 90 days of consent
- History of a left ventricular remodeling surgical procedure utilizing prosthetic material
-
Presence of a pacemaker and/or implantable cardioverter-defibrillator (ICD) generator with any of the following limitations/conditions:
- manufactured before the year 2000
- leads implanted < 6 weeks prior to consent
- non-transvenous epicardial, or abandoned leads
- subcutaneous ICDs
- leadless pacemakers
- any other condition that, in the judgment of device-trained staff, would deem an MRI contraindicated
- Pacemaker-dependence with an ICD (Note: pacemaker-dependent candidates without an ICD are not excluded)
- A cardiac resynchronization therapy (CRT) device implanted less than 3 months prior to consent
- Other MRI contraindications (e.g. patient body habitus incompatible with MRI)
- An appropriate ICD firing or anti-tachycardia pacing (ATP) for ventricular fibrillation or ventricular tachycardia within 30 days of consent
- Ventricular tachycardia ≥ 20 consecutive beats without an ICD within 3 months of consent, or symptomatic Mobitz II or higher degree atrioventricular block without a functioning pacemaker within 3 months of consent
- Presence of LV thrombus
- Evidence of active myocarditis
- Baseline maximal oxygen consumption (VO2 max) greater than 75% of age and gender based predictive values
- Baseline eGFR <35 ml/min/1.73m2
- Blood glucose levels (HbA1c) >10%
- Hematologic abnormality evidenced by hematocrit < 25%, white blood cell < 2,500/ul or platelet count < 100,000/ul
- Liver dysfunction evidenced by enzymes (AST and ALT) ˃ 3 times the upper limit of normal (ULN)
- Coagulopathy (INR ≥ 1.3) not due to a reversible cause (e.g., warfarin and/or Factor Xa inhibitors). Subjects who cannot be withdrawn from anticoagulation will be excluded.
- HIV and/or active hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Allergy to radiographic contrast material that cannot adequately be managed by premedication
- Known history of anaphylactic reaction to penicillin or streptomycin
- Received gene or cell-based therapy from any source within the previous 12 months
- History of malignancy within 5 years (i.e., subjects with prior malignancy must be disease free for 5 years), excluding basal cell carcinoma and cervical carcinoma in situ which have been definitively treated
- Condition that limits lifespan to < 1 year
- History of drug abuse (illegal "street" drugs except marijuana, or prescription medications not being used appropriately for a pre-existing medical condition) or alcohol abuse (≥ 5 drinks/day for ˃ 3 months), or documented medical, occupational, or legal problems arising from the use of alcohol or drugs within the past 24 months
- Participation in an investigational therapeutic or device trial within 30 days of consent
- Cognitive or language barriers that prohibit obtaining informed consent or any study elements
- Pregnancy or lactation or plans to become pregnant in the next 12 months
- Any other condition that, in the judgment of the Investigator or Sponsor, would impair enrollment, study product administration, or follow-up

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501811
United States, California | |
Stanford University School of Medicine (Falk Cardiovascular Research Center) | |
Stanford, California, United States, 94305 | |
United States, Florida | |
University of Florida-Department of Medicine | |
Gainesville, Florida, United States, 32610 | |
University of Miami-Interdisciplinary Stem Cell Institute | |
Miami, Florida, United States, 33101 | |
United States, Indiana | |
Indiana Center for Vascular Biology and Medicine | |
Indianapolis, Indiana, United States, 46202 | |
United States, Kentucky | |
University of Louisville | |
Louisville, Kentucky, United States, 40202 | |
United States, Minnesota | |
Minneapolis Heart Institute Foundation | |
Minneapolis, Minnesota, United States, 55407 | |
United States, Texas | |
Texas Heart Institute | |
Houston, Texas, United States, 77030 |
Study Chair: | Robert Simari, MD | CCTRN Steering Committee Chair |
Publications:
Responsible Party: | Barry R Davis, Professor of Biostatistics, The University of Texas Health Science Center, Houston |
ClinicalTrials.gov Identifier: | NCT02501811 |
Other Study ID Numbers: |
HSC-SPH-15-0413 5UM1HL087318 ( U.S. NIH Grant/Contract ) |
First Posted: | July 17, 2015 Key Record Dates |
Last Update Posted: | October 27, 2020 |
Last Verified: | October 2020 |
Heart Failure Ischemia Autologous Stem Cells LV dysfunction Mesenchymal Stem Cells |
c-kit+ Cells Combination Cell Therapy LV function Functional status |
Heart Failure Cardiomyopathies Heart Diseases Cardiovascular Diseases |
Plasma-lyte 148 Ophthalmic Solutions Pharmaceutical Solutions |