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| ID | Type | Description | Link |
|---|---|---|---|
| 5UM1HL087318 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This is a phase II, randomized, placebo-controlled clinical trial designed to assess feasibility, safety, and effect of autologous bone marrow-derived mesenchymal stem cells (MSCs) and c-kit+ cells both alone and in combination (Combo), compared to placebo (cell-free Plasmalyte-A medium) as well as each other, administered by transendocardial injection in subjects with ischemic cardiomyopathy.
This is a randomized, placebo-controlled clinical trial designed to evaluate the feasibility, safety, and effect of Combo, MSCs alone, and c-kit+ cells alone compared with placebo as well as each other in subjects with heart failure of ischemic etiology. Following a successful lead-in phase, a total of one hundred forty-four (144) subjects will be randomized (1:1:1:1) to receive Combo, MSCs, c-kit+ cells, or placebo. After randomization, baseline imaging, relevant harvest procedures, and study product injection, subjects will be followed up at 1 day, 1 week, 1 month, 3 months, 6 months and 12 months post study product injection. All subjects will receive study product injection (cells or placebo) using the NOGA® XP Mapping and Navigation System. Subjects will have delayed-enhanced magnetic resonance imaging (DEMRI) scans to assess scar size and LV function and structure at baseline and at 6 and 12 months post study product administration. All endpoints will be assessed at the 6 and 12 month visits which will occur 180 ±30 days and 365 ±30 days respectively from the day of study product injection (Day 0). For the purpose of the endpoint analysis and safety evaluations, the Investigators will utilize an "intention-to-treat" study population, however an as treated analysis will also be conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal Stem Cells (MSC) | Experimental | Target dose of 150 million MSCs |
|
| c-kit+ cells | Experimental | Target dose of 5 million c-kit+ cells |
|
| Combination Cells (MSC and c-kit+ cells) | Experimental | Target dose of 150 million MSCs and 5 million c-kit+ cells |
|
| Placebo (Plasmalyte A) | Placebo Comparator | Plasmalyte A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal Stem Cells (MSC) | Biological | 15 transendocardial injections of 0.4ml MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | Change in left ventricular ejection fraction as assessed via cardiac MRI | Baseline to 6 months |
| Change From Baseline in Global Strain (HARP MRI) | Change in global circumferential strain as assessed via cardiac MRI | Baseline to 6 months |
| Change From Baseline in Regional Strain (HARP MRI) | Change in regional longitudinal strain as assessed via cardiac MRI | Baseline to 6 months |
| Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVI) | Change in left ventricular end diastolic volume index as measured via cardiac MRI | Baseline to 6 months |
| Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVI) | Change in left ventricular end systolic volume index as assessed via cardiac MRI | Baseline to 6 months |
| Change From Baseline in Left Ventricular Sphericity Index | Change in left ventricular sphericity as assessed via cardiac MRI. Sphericity index is the ratio of the long and short axis measurements of the left ventricle. | Baseline to 6 months |
| Change From Baseline in Scar Size Percent (DEMRI) | Change in scar size percent as assessed via cardiac MRI |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Subjects With Events Between Randomization and Study Product Injection (SPI) That Preclude the Receipt of Product | Number and percent of subjects with events between randomization and study product injection (SPI) that preclude the subject from receiving product. Reasons include those who did not undergo harvest (n=6; death, subject withdraw, subject changed mind) and those who did not undergo SPI (n=9; death, LVAD placement, episodes of ventricular tachycardia, and cancelled procedures) |
Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Robert Simari, MD | CCTRN Steering Committee Chair | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine (Falk Cardiovascular Research Center) | Stanford | California | 94305 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23588961 | Background | Hare JM, Bolli R, Cooke JP, Gordon DJ, Henry TD, Perin EC, March KL, Murphy MP, Pepine CJ, Simari RD, Skarlatos SI, Traverse JH, Willerson JT, Szady AD, Taylor DA, Vojvodic RW, Yang PC, Moye LA; Cardiovascular Cell Therapy Research Network. Phase II clinical research design in cardiology: learning the right lessons too well: observations and recommendations from the Cardiovascular Cell Therapy Research Network (CCTRN). Circulation. 2013 Apr 16;127(15):1630-5. doi: 10.1161/CIRCULATIONAHA.112.000779. No abstract available. | |
| 19121814 |
| Label | URL |
|---|---|
| Cardiovascular Cell Therapy Research Network | View source |
Not provided
125 individuals consented, completed baseline testing, met eligibility criteria, and were randomized to study group. Reasons for failed eligibility (n=68) included investigator discretion, elevated LVEF, MRI contraindications, LV thrombus requiring anticoagulation therapy, elevated peak VO2, and other.
Enrollment took place at seven CCTRN centers between November 2016 and November 2018. The main centers are located in Texas, Florida (2 locations), Minnesota, Kentucky, Indiana, and California. Recruitment methods included www.clinicaltrials.gov, local heart failure clinics, and outreach to physician cardiologists. Original sample size of 144 was capped at 125 by NHLBI following review by DSMB of cell production, interim analysis, and power calculations. Power deemed adequate at 125 subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | MSCs + CPCs | Target dose of 150 million MSCs and 5 million CPCs |
| FG001 | MSCs | Target dose of 150 million MSCs |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 14, 2018 | Oct 27, 2020 |
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| c-kit+ cells | Biological | 15 transendocardial injections of 0.4ml c-kit+ cells administered to the left ventricle via NOGA Myostar injection catheter (single procedure) |
|
| Placebo (Plasmalyte A) | Biological | 15 transendocardial injections of 0.4ml placebo administered to the left ventricle via NOGA Myostar injection catheter (single procedure) |
|
|
| Baseline to 6 months |
| Change From Baseline in Scar Tissue Mass (DEMRI) | Change in scar tissue mass as assessed via cardiac MRI | Baseline to 6 months |
| Change From Baseline in Maximal Oxygen Consumption (Peak VO2) | Change in maximal oxygen consumption (peak V02) as assessed via treadmill | Baseline to 6 months |
| Change From Baseline in Exercise Tolerance (Six Minute Walk Test) | Change in distance walked (in meters) as measured by the 6 minute walk test. Two walk tests were completed at each endpoint visit (separated by 30 minutes). The average distance of the two walk tests was used for analysis. | Baseline to 6 months |
| Change From Baseline in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Score | Change in the quality of life summary score as measured by the Minnesota Living with Heart Failure Questionnaire. Minimum and maximum scores for the scale are 0 and 105 respectively. Lower scores indicative of better outcomes. | Baseline to 6 months |
| Change From Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) | Change in N-Terminal pro-Brain Natriuretic Peptide (NT-proBNP) as measured via laboratory blood draw | Baseline to 6 months |
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF)-Trajectory | The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm. | Assessed as a trajectory (baseline, 6 months, and 12 months) |
| Change From Baseline in Global Strain (HARP MRI)-Trajectory | The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm. | Assessed as a trajectory (baseline, 6 months, and 12 months) |
| Change From Baseline in Regional Strain (HARP MRI)-Trajectory | The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm. | Assessed as a trajectory (baseline, 6 months, and 12 months) |
| Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVI)-Trajectory | The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm. | Assessed as a trajectory (baseline, 6 months, and 12 months) |
| Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVI)-Trajectory | The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm. | Assessed as a trajectory (baseline, 6 months, 12 months) |
| Change From Baseline in Left Ventricular Sphericity Index-Trajectory | Sphericity index is the ratio of the long and short axis measurements of the left ventricle. The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm. | Assessed as a trajectory (baseline, 6 months, and 12 months) |
| Change From Baseline in Scar Size Percent (DEMRI)-Trajectory | The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm. | Assessed as a trajectory (baseline, 6 months, and 12 months) |
| Change From Baseline in Scar Tissue Mass (DEMRI)-Trajectory | The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm. | Assessed as a trajectory (baseline, 6 months, and 12 months) |
| Change From Baseline in Maximal Oxygen Consumption (Peak VO2)-Trajectory | The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm. | Assessed as a trajectory (baseline, 6 months, and 12 months) |
| Change From Baseline in Exercise Tolerance (Six Minute Walk Test)-Trajectory | Two walk tests were completed at each endpoint visit (separated by 30 minutes). The average distance of the two walk tests was used for analysis. The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm. | Assessed as a trajectory (baseline, 6 months, and 12 months) |
| Change From Baseline in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Score-Trajectory | Minimum and maximum scores for the scale are 0 and 105 respectively. Lower scores indicative of better outcomes. The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The 2nd and 3rd set of results represent differences for varying slopes from the interaction model. | Assessed as a trajectory (baseline, 6 months, and 12 months) |
| Change From Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)-Trajectory | Log transformation used. The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm. | Assessed as a trajectory (baseline, 6 months, and 12 months) |
| Participants With Major Adverse Cardiac Events (MACE) | Number of participants with adjudicated events including death, hospitalization for worsening heart failure, and/or other exacerbation of heart failure (non-hospitalization). | Baseline to End of 12 Month Visit Window, an average of 395 days following study product injection |
| Participants Experiencing Other Significant Clinical Events | Number of participants experiencing other significant adjudicated clinical events including: non-fatal stroke, non-fatal MI, coronary artery revascularization, ventricular tachycardia/fibrillation, and pericardial tamponade | Baseline to End of 12 Month Visit Window, an average of 395 days following study product injection |
| Cumulative Days Alive and Out of Hospital for Heart Failure | Days alive and out of hospital during the study evaluation period. Subjects were allotted a visit window extending 30 days past their anticipated 12-month visit. Some participants had extended 12-month visit windows due to the COVID-19 pandemic. | Baseline to End of 12 Month Visit Window, an average of 395 days following study product injection |
| Randomization to SPI, an average of 14 weeks |
| Subjects Who Have a Failed Bone Marrow Aspiration Procedure | Number and percent of subjects who do not successfully undergo bone marrow aspiration | During bone marrow aspiration procedure |
| Subjects Who Have a Failed Endomyocardial Biopsy Procedure | Number and percent of subjects who do not successfully undergo endomyocardial biopsy procedure. Note only participants who were assigned to MSC+CPC or to CPC groups had endomyocardial biopsy procedures attempted. | During endomyocardial biopsy procedure |
| Subject MSC Products Which Failed Release Criteria | Number and percent of subjects who have MSC products which failed release criteria | Harvest to Study Product Injection Procedure |
| Subject CPC Products Which Failed Release Criteria | Number and percent of subjects who have CPC products which failed release criteria | Harvest to Study Project Injection procedure |
| Subjects Who Receive Less Than 15 Injections During SPI | Number and percent of subjects who received less than 15 injections during SPI | During SPI procedure |
| Subjects Who Have at Least One Cardiac MRI Endpoint Measure That is Uninterpretable | 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 | Baseline to 12 months |
| University of Florida-Department of Medicine |
| Gainesville |
| Florida |
| 32610 |
| United States |
| University of Miami-Interdisciplinary Stem Cell Institute | Miami | Florida | 33101 | United States |
| Indiana Center for Vascular Biology and Medicine | Indianapolis | Indiana | 46202 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407 | United States |
| Texas Heart Institute | Houston | Texas | 77030 | United States |
| Background |
| Nazarian S, Halperin HR. How to perform magnetic resonance imaging on patients with implantable cardiac arrhythmia devices. Heart Rhythm. 2009 Jan;6(1):138-43. doi: 10.1016/j.hrthm.2008.10.021. Epub 2008 Oct 22. No abstract available. |
| 29703749 | Background | Bolli R, Hare JM, March KL, Pepine CJ, Willerson JT, Perin EC, Yang PC, Henry TD, Traverse JH, Mitrani RD, Khan A, Hernandez-Schulman I, Taylor DA, DiFede DL, Lima JAC, Chugh A, Loughran J, Vojvodic RW, Sayre SL, Bettencourt J, Cohen M, Moye L, Ebert RF, Simari RD; Cardiovascular Cell Therapy Research Network (CCTRN). Rationale and Design of the CONCERT-HF Trial (Combination of Mesenchymal and c-kit+ Cardiac Stem Cells As Regenerative Therapy for Heart Failure). Circ Res. 2018 Jun 8;122(12):1703-1715. doi: 10.1161/CIRCRESAHA.118.312978. Epub 2018 Apr 27. |
| 42003602 | Derived | Chacon-Alberty L, Tan X, Li M, Tang XL, Hochman-Mendez C, Bolli R. Changes in Circulating Biomarkers in Patients With Ischemic Heart Failure After Treatment With Autologous Mesenchymal Stromal Cells and c-Kit-Positive Cardiac Cells, Alone or in Combination: Results From the Cardiovascular Cell Therapy Research Network CONCERT-HF Clinical Trial. J Am Heart Assoc. 2026 May 5;15(9):e045963. doi: 10.1161/JAHA.125.045963. Epub 2026 Apr 20. |
| 34315432 | Derived | Kato Y, Kizer JR, Ostovaneh MR, Lazar J, Peng Q, van der Geest RJ, Lima JAC, Ambale-Venkatesh B. Extracellular volume-guided late gadolinium enhancement analysis for non-ischemic cardiomyopathy: The Women's Interagency HIV Study. BMC Med Imaging. 2021 Jul 27;21(1):116. doi: 10.1186/s12880-021-00649-6. |
| National Heart, Lung, and Blood Institute | View source |
| FG002 |
| CPCs |
Target dose of 5 million CPCs |
| FG003 | Placebo | Plasmalyte A |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Denominators are of those reporting
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MSCs + CPCs | Target dose of 150 million MSCs and 5 million CPCs |
| BG001 | MSCs | Target dose of 150 million MSCs |
| BG002 | CPCs | Target dose of 5 million CPCs |
| BG003 | Placebo | Plasmalyte A |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| ||||||||||
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
| ||||||||||
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
| ||||||||||
| Diabetes | One participant missing data | Count of Participants | Participants |
| ||||||||||
| Hypertension | One participant missing data | Count of Participants | Participants |
| ||||||||||
| Smoking (Lifetime) | Smoking (Lifetime) includes previous and current smokers | Count of Participants | Participants |
| ||||||||||
| Previous Hospitalization for Heart Failure | Count of Participants | Participants |
| |||||||||||
| Previous Emergency Department Visit for Heart Failure | Count of Participants | Participants |
| |||||||||||
| Ongoing Ischemia | Count of Participants | Participants |
| |||||||||||
| New York Heart Association Class 1 | Physician's use the NYHA classification system to place patients into one of four categories based on how much they are limited during physical activity. Class 1 is characterized by no limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). | Count of Participants | Participants |
| ||||||||||
| New York Heart Association Class 2 | Physician's use the NYHA classification system to place patients into one of four categories based on how much they are limited during physical activity. Class 2 is characterized by slight limitation of physical activity. The patient is comfortable at rest, however ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). | Count of Participants | Participants |
| ||||||||||
| New York Heart Association Class 3 | Physician's use the NYHA classification system to place patients into one of four categories based on how much they are limited during physical activity. Class 3 is characterized by marked limitation of physical activity. The patient is comfortable at rest, however less than ordinary activity causes fatigue, palpitation, or dyspnea. | Count of Participants | Participants |
| ||||||||||
| Presence of a Cardiac Device | Presence of an internal cardiac defibrillator (ICD) or biventricular pacing and ICD. | Count of Participants | Participants |
| ||||||||||
| Number of Myocardial Infarctions | Number of Myocardial Infarctions (lifetime) | Mean | Standard Deviation | events |
| |||||||||
| Percutaneous Coronary Intervention (PCI) | Variable represents number of patients having undergone PCI procedures (lifetime). | Count of Participants | Participants |
| ||||||||||
| Coronary Artery Bypass Grafting (CABG) | Variable represents the number of patients having undergone a CABG procedure (lifetime). | Count of Participants | Participants |
| ||||||||||
| Multi-Vessel Disease | Multiple vessels supplying blood flow to the left ventricle are affected | Count of Participants | Participants |
| ||||||||||
| Atrial Fibrillation | Variable represents number of patients experiencing atrial fibrillation (lifetime) | Count of Participants | Participants |
| ||||||||||
| Sustained Ventricular Arrhythmia | Variable represents the number of patients experiencing sustained ventricular arrhythmia (lifetime) | One participant missing data | Count of Participants | Participants |
| |||||||||
| Valvular Heart Disease | Variable represents the number of patients diagnosed with valvular heart disease (lifetime) | Count of Participants | Participants |
| ||||||||||
| Beta Blockers | Baseline medications include the use of beta blockers. | Count of Participants | Participants |
| ||||||||||
| ACE Inhibitors | Baseline medications include the use of angiotensin converting enzyme inhibitors (ACE inhibitors) | Count of Participants | Participants |
| ||||||||||
| Angiotensin II Blockers | Baseline medications included the use of angiotensin II blockers | Count of Participants | Participants |
| ||||||||||
| Entresto | Baseline medications included the use of Entresto | Count of Participants | Participants |
| ||||||||||
| Aldosterone Antagonists | Baseline medications included the use of aldosterone antagonists | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | Change in left ventricular ejection fraction as assessed via cardiac MRI | Participants with available analyzable LVEF at baseline and 6 months | Posted | Mean | Standard Deviation | percentage of end diastolic volume | Baseline to 6 months |
|
|
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| Primary | Change From Baseline in Global Strain (HARP MRI) | Change in global circumferential strain as assessed via cardiac MRI | Participants with available analyzable global circumferential strain at baseline and 6 months. | Posted | Mean | Standard Deviation | percent | Baseline to 6 months |
|
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| Primary | Change From Baseline in Regional Strain (HARP MRI) | Change in regional longitudinal strain as assessed via cardiac MRI | Participants with available analyzable regional longitudinal strain at baseline and 6 months | Posted | Mean | Standard Deviation | percent | Baseline to 6 months |
|
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| Primary | Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVI) | Change in left ventricular end diastolic volume index as measured via cardiac MRI | Participants with available analyzable LVEDVI at baseline and six months | Posted | Mean | Standard Deviation | mL/m^2 | Baseline to 6 months |
|
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| Primary | Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVI) | Change in left ventricular end systolic volume index as assessed via cardiac MRI | Participants with available analyzable LVESVI at baseline and 6 months | Posted | Mean | Standard Deviation | mL/m^2 | Baseline to 6 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Left Ventricular Sphericity Index | Change in left ventricular sphericity as assessed via cardiac MRI. Sphericity index is the ratio of the long and short axis measurements of the left ventricle. | Participants with available analyzable LV sphericity index at baseline and 6 months | Posted | Mean | Standard Deviation | ratio-unitless | Baseline to 6 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Scar Size Percent (DEMRI) | Change in scar size percent as assessed via cardiac MRI | Participants with available and analyzable scar size data at baseline and 6 months | Posted | Mean | Standard Deviation | percentage of mass | Baseline to 6 months |
|
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| Primary | Change From Baseline in Scar Tissue Mass (DEMRI) | Change in scar tissue mass as assessed via cardiac MRI | Participants with available and analyzable scar size data at baseline and 6 months | Posted | Mean | Standard Deviation | grams | Baseline to 6 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Maximal Oxygen Consumption (Peak VO2) | Change in maximal oxygen consumption (peak V02) as assessed via treadmill | Participants with available analyzable peak VO2 data from baseline and 6 months | Posted | Mean | Standard Deviation | ml/kg/min | Baseline to 6 months |
|
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| Primary | Change From Baseline in Exercise Tolerance (Six Minute Walk Test) | Change in distance walked (in meters) as measured by the 6 minute walk test. Two walk tests were completed at each endpoint visit (separated by 30 minutes). The average distance of the two walk tests was used for analysis. | Participants with available analyzable exercise tolerance data at baseline and 6 months | Posted | Mean | Standard Deviation | meters | Baseline to 6 months |
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| Primary | Change From Baseline in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Score | Change in the quality of life summary score as measured by the Minnesota Living with Heart Failure Questionnaire. Minimum and maximum scores for the scale are 0 and 105 respectively. Lower scores indicative of better outcomes. | Participants with available analyzable MLHFQ summary score at baseline and 6 months | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6 months |
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| Primary | Change From Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) | Change in N-Terminal pro-Brain Natriuretic Peptide (NT-proBNP) as measured via laboratory blood draw | Participants with available analyzable NT-proBNP values at baseline and 6 months. Log transformation used. P-values obtained from transformed data. | Posted | Mean | Standard Deviation | pg/ml | Baseline to 6 months |
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| Primary | Change From Baseline in Left Ventricular Ejection Fraction (LVEF)-Trajectory | The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm. | Participants who had analyzable LVEF at baseline, 6 months, and 12 months. | Posted | Least Squares Mean | Standard Error | percentage of end diastolic volume | Assessed as a trajectory (baseline, 6 months, and 12 months) |
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| Primary | Change From Baseline in Global Strain (HARP MRI)-Trajectory | The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm. | Participants who had available analyzable global circumferential strain at baseline, 6 month, and 12 month. | Posted | Least Squares Mean | Standard Error | percent | Assessed as a trajectory (baseline, 6 months, and 12 months) |
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| Primary | Change From Baseline in Regional Strain (HARP MRI)-Trajectory | The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm. | Participants who had analyzable regional strain at baseline, 6 months, and 12 months | Posted | Least Squares Mean | Standard Error | percent | Assessed as a trajectory (baseline, 6 months, and 12 months) |
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| Primary | Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVI)-Trajectory | The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm. | Participants who had analyzable LVEDVI at baseline, 6 months, and 12 months | Posted | Least Squares Mean | Standard Error | mL/m^2 | Assessed as a trajectory (baseline, 6 months, and 12 months) |
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| Primary | Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVI)-Trajectory | The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm. | Participants who had analyzable LVESVI at baseline, 6 months, and 12 months | Posted | Least Squares Mean | Standard Error | mL/m^2 | Assessed as a trajectory (baseline, 6 months, 12 months) |
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| Primary | Change From Baseline in Left Ventricular Sphericity Index-Trajectory | Sphericity index is the ratio of the long and short axis measurements of the left ventricle. The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm. | Participants who had analyzable LV Sphericity Index at baseline, 6 months, and 12 months | Posted | Least Squares Mean | Standard Error | ratio-unitless | Assessed as a trajectory (baseline, 6 months, and 12 months) |
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| Primary | Change From Baseline in Scar Size Percent (DEMRI)-Trajectory | The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm. | Participants who had analyzable scar size percent at baseline, 6 months, and 12 months | Posted | Least Squares Mean | Standard Error | percentage of mass | Assessed as a trajectory (baseline, 6 months, and 12 months) |
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| Primary | Change From Baseline in Scar Tissue Mass (DEMRI)-Trajectory | The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm. | Participants who had analyzable scar size data at baseline, 6 months, and 12 months | Posted | Least Squares Mean | Standard Error | grams | Assessed as a trajectory (baseline, 6 months, and 12 months) |
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| Primary | Change From Baseline in Maximal Oxygen Consumption (Peak VO2)-Trajectory | The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm. | Participants who had analyzable peak VO2 at baseline, 6 months, and 12 months | Posted | Least Squares Mean | Standard Error | ml/kg/min | Assessed as a trajectory (baseline, 6 months, and 12 months) |
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| Primary | Change From Baseline in Exercise Tolerance (Six Minute Walk Test)-Trajectory | Two walk tests were completed at each endpoint visit (separated by 30 minutes). The average distance of the two walk tests was used for analysis. The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm. | Participants who had analyzable six minute walk tests at baseline, 6 months, and 12 months | Posted | Least Squares Mean | Standard Error | meters | Assessed as a trajectory (baseline, 6 months, and 12 months) |
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| Primary | Change From Baseline in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Score-Trajectory | Minimum and maximum scores for the scale are 0 and 105 respectively. Lower scores indicative of better outcomes. The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The 2nd and 3rd set of results represent differences for varying slopes from the interaction model. | Participants who had analyzable MLHFQ scores at baseline, 6 months, and 12 months | Posted | Least Squares Mean | Standard Error | score on a scale | Assessed as a trajectory (baseline, 6 months, and 12 months) |
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| Primary | Change From Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)-Trajectory | Log transformation used. The change in this measure over time is assessed using a repeated measures linear regression model of trajectory (change over time). The first set of results reflects the model within each arm and represents change per 6 months within that treatment arm. The second set of results reflects an overall model with all patients and the results represent the change per 6 months irrespective of treatment arm. | Participants who had analyzable NT-proBNP values at baseline, 6 months, and 12 months | Posted | Least Squares Mean | Standard Error | pg/ml | Assessed as a trajectory (baseline, 6 months, and 12 months) |
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| Primary | Participants With Major Adverse Cardiac Events (MACE) | Number of participants with adjudicated events including death, hospitalization for worsening heart failure, and/or other exacerbation of heart failure (non-hospitalization). | Population includes all randomized participants | Posted | Count of Participants | Participants | Baseline to End of 12 Month Visit Window, an average of 395 days following study product injection |
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| Primary | Participants Experiencing Other Significant Clinical Events | Number of participants experiencing other significant adjudicated clinical events including: non-fatal stroke, non-fatal MI, coronary artery revascularization, ventricular tachycardia/fibrillation, and pericardial tamponade | Population includes all randomized participants | Posted | Count of Participants | Participants | Baseline to End of 12 Month Visit Window, an average of 395 days following study product injection |
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| Primary | Cumulative Days Alive and Out of Hospital for Heart Failure | Days alive and out of hospital during the study evaluation period. Subjects were allotted a visit window extending 30 days past their anticipated 12-month visit. Some participants had extended 12-month visit windows due to the COVID-19 pandemic. | Comparison of the 4 treatment groups on days alive and out of the hospital for heart failure during the 12 month study evaluation period; adjusted for time in followup. Analysis includes all randomized participants. | Posted | Mean | Standard Deviation | days | Baseline to End of 12 Month Visit Window, an average of 395 days following study product injection |
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| Other Pre-specified | Subjects With Events Between Randomization and Study Product Injection (SPI) That Preclude the Receipt of Product | Number and percent of subjects with events between randomization and study product injection (SPI) that preclude the subject from receiving product. Reasons include those who did not undergo harvest (n=6; death, subject withdraw, subject changed mind) and those who did not undergo SPI (n=9; death, LVAD placement, episodes of ventricular tachycardia, and cancelled procedures) | All randomized participants | Posted | Count of Participants | Participants | Randomization to SPI, an average of 14 weeks |
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| Other Pre-specified | Subjects Who Have a Failed Bone Marrow Aspiration Procedure | Number and percent of subjects who do not successfully undergo bone marrow aspiration | Participants who attended their harvest visit | Posted | Count of Participants | Participants | During bone marrow aspiration procedure |
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| Other Pre-specified | Subjects Who Have a Failed Endomyocardial Biopsy Procedure | Number and percent of subjects who do not successfully undergo endomyocardial biopsy procedure. Note only participants who were assigned to MSC+CPC or to CPC groups had endomyocardial biopsy procedures attempted. | Participants who attended the harvest visit and were assigned to either MSCs+CPCs or CPCs. | Posted | Count of Participants | Participants | During endomyocardial biopsy procedure |
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| Other Pre-specified | Subject MSC Products Which Failed Release Criteria | Number and percent of subjects who have MSC products which failed release criteria | Population includes only those participant products assigned to treatment groups including MSCs. | Posted | Count of Participants | Participants | Harvest to Study Product Injection Procedure |
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| Other Pre-specified | Subject CPC Products Which Failed Release Criteria | Number and percent of subjects who have CPC products which failed release criteria | Population includes only those participant products assigned to treatment groups including CPCs. | Posted | Count of Participants | Participants | Harvest to Study Project Injection procedure |
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| Other Pre-specified | Subjects Who Receive Less Than 15 Injections During SPI | Number and percent of subjects who received less than 15 injections during SPI | Participants who received study product administration | Posted | Count of Participants | Participants | During SPI procedure |
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| Other Pre-specified | Subjects Who Have at Least One Cardiac MRI Endpoint Measure That is Uninterpretable | 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 | Participants completing an MRI scan at both baseline and 12 months | Posted | Count of Participants | Participants | Baseline to 12 months |
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Events reported occurred between randomization and the end of 12 Month Visit Window (an average of 395 days following study product injection).
Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MSCs + CPCs | Target dose of 150 million MSCs and 5 million CPCs | 2 | 33 | 14 | 33 | 10 | 33 |
| EG001 | MSCs | Target dose of 150 million MSCs | 3 | 29 | 14 | 29 | 6 | 29 |
| EG002 | CPCs | Target dose of 5 million CPCs | 2 | 31 | 13 | 31 | 14 | 31 |
| EG003 | Placebo | Plasmalyte A | 4 | 32 | 18 | 32 | 15 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia or Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
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| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| Angina pectoris or angina unstable | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| Bundle branch block left | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| Cardiac failure acute | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| Cardiac failure chronic | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| Cardiac tamponade | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| Pericardial haemorrhage | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| Pulseless electrical activity | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| Ventricular arrhythmia | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| Ventricular fibrillation | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Sudden cardiac death | General disorders | MedDRA (19.1) | Systematic Assessment |
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| Death | General disorders | MedDRA (19.1) | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA (19.1) | Systematic Assessment |
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| Medical device site erosion | General disorders | MedDRA (19.1) | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
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| Hepatocellular injury | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Enterocolitis infectious | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Oesophageal candidiasis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Subcutaneous abscess | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Intentional overdose | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
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| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
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| Vascular access site pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
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| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
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| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Device lead damage | Product Issues | MedDRA (19.1) | Systematic Assessment |
| |
| Device inappropriate shock delivery | Product Issues | MedDRA (19.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Ventricular assist device insertion | Surgical and medical procedures | MedDRA (19.1) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
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| Aortic aneurysm | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
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| Peripheral artery aneurysm | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
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| Arteriovenous fistula | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
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| Hypovolaemic shock | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
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| Angina pectoris or angina unstable | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cardiac resynchronisation therapy | Surgical and medical procedures | MedDRA (19.1) | Systematic Assessment |
|
Relatively small group sizes overall. Relatively long interval between harvest visit and study product injection (approx. 14wks) resulting in patient attrition. Failure of cells to grow from tissue of some patients, resulting in some patients crossing over into other treatment groups.
Not provided
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shelly Sayre, M.P.H. Project Manager | University of Texas-Houston School of Public Health | 713-500-9529 | Shelly.L.Sayre@uth.tmc.edu |
| ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 4, 2019 | Oct 27, 2020 | Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D007511 | Ischemia |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018754 | Ventricular Dysfunction |
Not provided
Not provided
| ID | Term |
|---|---|
| C048013 | Plasmalyte A |
Not provided
Not provided
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| ANCOVA |
The change in LVEF was compared using ANCOVA analyses adjusting for baseline values. |
| 0.499 |
| Mean Difference (Final Values) |
| 0.70 |
| Standard Error of the Mean |
| 0.96 |
| 2-Sided |
| 95 |
| -1.229 |
| 2.635 |
Confidence intervals based on t-test |
| Superiority |
| ANCOVA | The change in LVEF was compared using ANCOVA analyses adjusting for baseline values. | 0.578 | Mean Difference (Final Values) | 1.38 | Standard Error of the Mean | 1.05 | 2-Sided | 95 | -0.729 | 3.485 | Confidence intervals based on t-test | Superiority |
| ANCOVA | The change in LVEF was compared using ANCOVA analyses adjusting for baseline values. | 0.523 | Mean Difference (Final Values) | -1.46 | Standard Error of the Mean | 1.04 | 2-Sided | 95 | -3.552 | 0.629 | Confidence intervals based on t-test | Superiority |
| ANCOVA | The change in LVEF was compared using ANCOVA analyses adjusting for baseline values. | 0.471 | Mean Difference (Final Values) | -0.79 | Standard Error of the Mean | 0.95 | 2-Sided | 95 | -2.7 | 1.127 | Confidence intervals based on t-test | Superiority |
| ANCOVA | The change in LVEF was compared using ANCOVA analyses adjusting for baseline values. | 0.485 | Mean Difference (Final Values) | 0.67 | Standard Error of the Mean | 0.95 | 2-Sided | 95 | -1.240 | 2.590 | Confidence intervals based on t-test | Superiority |
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