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| ID | Type | Description | Link |
|---|---|---|---|
| U54HL081028 | U.S. NIH Grant/Contract | View source |
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Difficulty in recruitment.
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Johns Hopkins University Specialized Center for Cell Based Therapy | OTHER |
| The Emmes Company, LLC | INDUSTRY |
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Heart attacks are a leading cause of death in both men and women in the United States. When a person has a heart attack, blood is unable to reach a certain area of the heart, and if the blood supply is not re-established quickly, that area of the heart can suffer permanent damage. While recovery from a heart attack can be managed through medications and lifestyle changes, these treatments can not reverse the original damage to the heart. Current research is focusing on the development of cell-based therapies using stem cells to repair organs that have been irreversibly damaged by disease. A specific form of stem cells, called adult mesenchymal stem cells (MSCs), has shown promise for heart repair. This study will evaluate the safety and effectiveness of injecting MSCs into the heart to repair and restore heart function in people who have had a heart attack and who are having heart surgery for coronary artery bypass grafting (CABG).
Participation in this study will last 18 months. Potential participants will undergo initial screening 5 to 7 weeks prior to CABG surgery. Screening will include a physical exam, blood draw, pregnancy test, questions about medical history, current medications, and alcohol or drug use, an electrocardiogram (ECG), magnetic resonance imaging (MRI) of the heart, questionnaires, an echocardiogram and a computed tomography (CT) scan. Eligible participants will then undergo two baseline visits within 6 weeks of their scheduled surgery. Baseline Visit 1 will consist of vital sign measurements, a bone marrow aspiration to obtain MSCs and a blood draw for a biomarker test. Baseline Visit 2 will include treadmill test, 6-minute walk test, pulmonary function (FEV1) study and a 48 Hour Ambulatory ECG. After the second baseline visit, participants will be assigned randomly to receive either MSCs or placebo after surgery.
On the day of surgery, once all of the bypass grafts have been placed, a high or low dose of MSCs or placebo will be injected into a damaged area of the heart that did not receive a bypass graft. After receiving the injections, participants will remain in the hospital for up to 7 days. During this stay, participants will undergo a daily blood draw, urine test, ECG, and ambulatory ECG monitoring for the first 96 hours after surgery.
Upon being discharged, participants will return for monthly visits for 6 months and for follow-up visits 12 and 18 months after surgery. These visits will repeat most initial screening and baseline tests. There will be one additional visit 14 days after surgery, which will include questions about side effects, a physical exam, and a 48-hour ambulatory ECG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lower dose mesenchymal stem cell (MSC) injection | Experimental | Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 10^7 cells |
|
| Higher dose MSC injection | Experimental | Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 10^8 cells |
|
| (3) Placebo | Placebo Comparator | Participants will receive placebo injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lower dose mesenchymal stem cell (MSC) injection | Biological | Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 10^7 cells. The injections will be administered following completion of CABG surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Serious Adverse Events | Six-month post-CABG surgery serious adverse event (SAE) proportion of patients experiencing a composite of sustained ventricular arrhythmias, (lasting longer than 15 seconds), with hemodynamic compromise, sudden unexpected death at six months, ectopic tissue formation at 12 months by chest/abdomen/pelvis CT exam. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Infarct Scar Size (ISS) Over 18 Month Period | Change in infarct scar size (ISS) between baseline and 6-month and 18 month visits as determined by delayed contrast-enhanced MRI. | Baseline, 6 Months, 18 Months |
| Left Ventricular Function (LVF) in Region of MSC Injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua M. Hare, MD | University of Miami | Principal Investigator |
| Gary Gerstenblith, MD | Johns Hopkins University | Principal Investigator |
| John V. Conte, MD | Johns Hopkins University | Principal Investigator |
| Steven P. Schulman, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States | ||
| Johns Hopkins University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24565698 | Result | Karantalis V, DiFede DL, Gerstenblith G, Pham S, Symes J, Zambrano JP, Fishman J, Pattany P, McNiece I, Conte J, Schulman S, Wu K, Shah A, Breton E, Davis-Sproul J, Schwarz R, Feigenbaum G, Mushtaq M, Suncion VY, Lardo AC, Borrello I, Mendizabal A, Karas TZ, Byrnes J, Lowery M, Heldman AW, Hare JM. Autologous mesenchymal stem cells produce concordant improvements in regional function, tissue perfusion, and fibrotic burden when administered to patients undergoing coronary artery bypass grafting: The Prospective Randomized Study of Mesenchymal Stem Cell Therapy in Patients Undergoing Cardiac Surgery (PROMETHEUS) trial. Circ Res. 2014 Apr 11;114(8):1302-10. doi: 10.1161/CIRCRESAHA.114.303180. Epub 2014 Feb 24. |
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This trial, which originally was designed to enroll 45 patients, was suspended after 9 patients were enrolled because of slow accrual.
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| ID | Title | Description |
|---|---|---|
| FG000 | (1) Lower MSC Dose | Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Placebo | Genetic | Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA). |
|
| Higher dose MSC injection | Biological | Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 10^8 cells. The injections will be administered following completion of CABG surgery. |
|
The Left Ventricular Function differences in the region of MSC injection were evaluated. LVF is evaluated via ECHO as the percentage of ejected blood. |
| Assessed at Baseline and 18 Months |
| Regional Left Ventricular Wall Thickening | Difference between baseline and 18 month regional left ventricular wall thickening as determined by MRI. | Assessed at Baseline and 18 months |
| Left Ventricular End Diastolic Wall Thickness | Difference between the baseline and 18 month left ventricular end diastolic wall thickness as determined by MRI and echocardiogram. | Assessed at Baseline and 18 months |
| Change in Left Ventricular End Diastolic and Systolic Volume | Change in left ventricular end diastolic and systolic volume as determined by MRI and echocardiogram. | Baseline, 6 Months, 18 Months |
| Change in Left Ventricular Ejection Fraction | Change between baseline to 6-month and 18-month left ventricular ejection fraction (LVEF) as determined by MRI and echocardiogram. | Baseline to 6 Months, Baseline to 18 Months |
| Change in Peak Volume Oxygen | Change in Peak VO2 as determined by treadmill test (mL/mg/min) from Baseline to 6 and from baseline to 18 months | Baseline, 6 Months, 18 Months |
| Change in Six Minute Walk Test | Change in Six Minute Walk Test (in meters) from Baseline to 6 Months and Baseline to 18 Months | Baseline, 6 Months, 18 Months |
| Change in NYHA Functional Class | Change in New York Heart Association (NYHA) Functional Classification based on patient's self reported activity level. Worsened: documented increase in limitations of physical activity as self-described by subject Improved: documented decrease in limitations of physical activity as self-described by subject Unchanged: no documented change in limitations of physical activity as self-described by subject | Baseline to 6 Months, 6 months to 18 Months |
| Minnesota Living With Heart Failure Questionnaire Scores | Minnesota Living with Heart Failure (MLHF) questionnaire has a total score from 0 to 105. A higher score indicates that participants heart failure is preventing them from living their lives measured at two time points. | Assessed at 6 Months and 18 Months |
| Incidence of Major Adverse Cardiac Events (MACE) | Incidence of Major Adverse Cardiac Events (MACE). A composite incidence of (1) death, (2) hospitalization for heart failure, or (3) non-fatal recurrent Ml. | 18 Months |
| Number of Participants With Abnormal 48-Hour Ambulatory ECG Recordings | Ambulatory ECG monitoring is the most widely employed technology for the evaluation of a patient with symptoms suggestive of cardiac arrhythmia or conduction abnormality. When the patient returns for follow up the 48- Hour Ambulatory monitor provides the data to the site staff to detect any abnormal recordings based upon standard ECG protocol. | Assessed at 6 Months, 12 Months, and 18 Months |
| Change in Pulmonary Function | Change in Pulmonary Function from Baseline to 6 month, Baseline to 12 month, and Baseline to 18 month visits as measured by forced expiratory volume in 1 second (FEV1) | Baseline, 6 Months, 12 Months, 18 Months |
| Serial Troponin Values (ng/mL) | Serial Troponin Values (ng/mL) Values from Baseline to 48 Hours Post CABG | Assessed at Baseline, 12 hours, 24 hours, 36 hours, and 48 hours post CABG |
| Creatinine Kinase - Muscle/Brain (MB) (ng/mL) | Creatinine Kinase MB (ng/mL) Values every 12 hours from Baseline to 48 Hours Post CABG | Assessed at Baseline, 12 Hours, 24 Hours, 36 Hours, and 48 hours post CABG |
| Number of Clinically Significant Laboratory Values | Clinically significant laboratory values are first determined via standard laboratory normal values from a CAP and CLIA certified Laboratory and then assessed by investigator based on specific patient conditions and disease state. | 18 Months |
| Rate of Treatment Emergent Adverse Events | Rate of Treatment Emergent Adverse Events Post Coronary Artery Bypass Graft (CABG) at 6 Months, 12 Months, and 18 Months | Assessed at 6 Months, 12 Months, and 18 Months |
| Number of Abnormal Echocardiogram Readings 2 Days Post CABG. | The number of abnormal Echocardiogram readings 2 Days Post CABG will be documented based on transthoracic Echocardiographic standards. However, although Echocardiograms 2 days post CABG operation may show abnormalities which is standard in this population, this testing is instrumental because it measures End- diastolic wall thickness and Left ventricular volumes at end-diastole and end-systole. | Day 2 |
| Baltimore |
| Maryland |
| 21205 |
| United States |
| FG001 | (2) Higher MSC Dose | Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery. |
| FG002 | (3) Placebo Injection | Participants will receive placebo injections Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | (1) Lower MSC Dose | Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery. |
| BG001 | (2) Higher MSC Dose | Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery. |
| BG002 | (3) Placebo | Participants will receive placebo injections Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA). |
| BG003 | 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 |
|
| 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 | Number of Patients With Serious Adverse Events | Six-month post-CABG surgery serious adverse event (SAE) proportion of patients experiencing a composite of sustained ventricular arrhythmias, (lasting longer than 15 seconds), with hemodynamic compromise, sudden unexpected death at six months, ectopic tissue formation at 12 months by chest/abdomen/pelvis CT exam. | Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo. | Posted | Count of Participants | Participants | 12 Months |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Infarct Scar Size (ISS) Over 18 Month Period | Change in infarct scar size (ISS) between baseline and 6-month and 18 month visits as determined by delayed contrast-enhanced MRI. | One placebo subject expired Day 3 post injection. Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo. | Posted | Mean | 95% Confidence Interval | Grams (g) | Baseline, 6 Months, 18 Months |
|
| |||||||||||||||||||||||||||||
| Secondary | Left Ventricular Function (LVF) in Region of MSC Injection | The Left Ventricular Function differences in the region of MSC injection were evaluated. LVF is evaluated via ECHO as the percentage of ejected blood. | Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo. One placebo subject expired Day 3 post injection. | Posted | Mean | Standard Error | percentage of ejected blood | Assessed at Baseline and 18 Months |
|
| |||||||||||||||||||||||||||||
| Secondary | Regional Left Ventricular Wall Thickening | Difference between baseline and 18 month regional left ventricular wall thickening as determined by MRI. | Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo.One placebo subject expired Day 3 post injection. | Posted | Mean | Standard Error | mm | Assessed at Baseline and 18 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Left Ventricular End Diastolic Wall Thickness | Difference between the baseline and 18 month left ventricular end diastolic wall thickness as determined by MRI and echocardiogram. | Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo. One placebo subject expired Day 3 post injection. | Posted | Mean | Standard Error | mm | Assessed at Baseline and 18 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Left Ventricular End Diastolic and Systolic Volume | Change in left ventricular end diastolic and systolic volume as determined by MRI and echocardiogram. | Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo.One placebo subject expired Day 3 post injection. | Posted | Mean | 95% Confidence Interval | ml | Baseline, 6 Months, 18 Months |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Left Ventricular Ejection Fraction | Change between baseline to 6-month and 18-month left ventricular ejection fraction (LVEF) as determined by MRI and echocardiogram. | Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo. One placebo subject expired Day 3 post injection. | Posted | Mean | 95% Confidence Interval | percentage of Ejection Fraction | Baseline to 6 Months, Baseline to 18 Months |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Peak Volume Oxygen | Change in Peak VO2 as determined by treadmill test (mL/mg/min) from Baseline to 6 and from baseline to 18 months | Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo. One placebo subject expired Day 3 post injection. | Posted | Mean | 95% Confidence Interval | (mL/mg/min) | Baseline, 6 Months, 18 Months |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Six Minute Walk Test | Change in Six Minute Walk Test (in meters) from Baseline to 6 Months and Baseline to 18 Months | Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo. One placebo subject expired Day 3 post injection. | Posted | Median | 95% Confidence Interval | Meters | Baseline, 6 Months, 18 Months |
|
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| Secondary | Change in NYHA Functional Class | Change in New York Heart Association (NYHA) Functional Classification based on patient's self reported activity level. Worsened: documented increase in limitations of physical activity as self-described by subject Improved: documented decrease in limitations of physical activity as self-described by subject Unchanged: no documented change in limitations of physical activity as self-described by subject | Due to the early termination of the study,there was an insufficient sample size of the MSC treated participants.The statistical analysis plan was revised to combine the low and high dose groups.1 treated subject's NYHA class was not captured at the 18 Month time point.1 placebo treated subject expired prior to 6 and 18 months NYHA class assessment. | Posted | Count of Participants | Participants | Baseline to 6 Months, 6 months to 18 Months |
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| Secondary | Minnesota Living With Heart Failure Questionnaire Scores | Minnesota Living with Heart Failure (MLHF) questionnaire has a total score from 0 to 105. A higher score indicates that participants heart failure is preventing them from living their lives measured at two time points. | Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo. One placebo subject expired Day 3 post injection. | Posted | Mean | 95% Confidence Interval | score on a scale | Assessed at 6 Months and 18 Months |
|
| |||||||||||||||||||||||||||||
| Secondary | Incidence of Major Adverse Cardiac Events (MACE) | Incidence of Major Adverse Cardiac Events (MACE). A composite incidence of (1) death, (2) hospitalization for heart failure, or (3) non-fatal recurrent Ml. | Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo. | Posted | Number | # of Major Adverse Cardiac Events (MACE) | 18 Months |
|
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| Secondary | Number of Participants With Abnormal 48-Hour Ambulatory ECG Recordings | Ambulatory ECG monitoring is the most widely employed technology for the evaluation of a patient with symptoms suggestive of cardiac arrhythmia or conduction abnormality. When the patient returns for follow up the 48- Hour Ambulatory monitor provides the data to the site staff to detect any abnormal recordings based upon standard ECG protocol. | Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo. One placebo subject expired Day 3 post injection. | Posted | Count of Participants | Participants | Assessed at 6 Months, 12 Months, and 18 Months |
|
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| Secondary | Change in Pulmonary Function | Change in Pulmonary Function from Baseline to 6 month, Baseline to 12 month, and Baseline to 18 month visits as measured by forced expiratory volume in 1 second (FEV1) | Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo. One placebo subject expired Day 3 post injection. | Posted | Mean | 95% Confidence Interval | Liters | Baseline, 6 Months, 12 Months, 18 Months |
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| Secondary | Serial Troponin Values (ng/mL) | Serial Troponin Values (ng/mL) Values from Baseline to 48 Hours Post CABG | Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo. | Posted | Median | 95% Confidence Interval | ng/mL | Assessed at Baseline, 12 hours, 24 hours, 36 hours, and 48 hours post CABG |
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| Secondary | Creatinine Kinase - Muscle/Brain (MB) (ng/mL) | Creatinine Kinase MB (ng/mL) Values every 12 hours from Baseline to 48 Hours Post CABG | Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo. | Posted | Median | 95% Confidence Interval | ng/mL | Assessed at Baseline, 12 Hours, 24 Hours, 36 Hours, and 48 hours post CABG |
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| Secondary | Number of Clinically Significant Laboratory Values | Clinically significant laboratory values are first determined via standard laboratory normal values from a CAP and CLIA certified Laboratory and then assessed by investigator based on specific patient conditions and disease state. | Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo. One placebo subject expired Day 3 post injection. | Posted | Number | Incidents | 18 Months |
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| Secondary | Rate of Treatment Emergent Adverse Events | Rate of Treatment Emergent Adverse Events Post Coronary Artery Bypass Graft (CABG) at 6 Months, 12 Months, and 18 Months | Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo. | Posted | Mean | 95% Confidence Interval | Number of Adverse Events | Assessed at 6 Months, 12 Months, and 18 Months |
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| Secondary | Number of Abnormal Echocardiogram Readings 2 Days Post CABG. | The number of abnormal Echocardiogram readings 2 Days Post CABG will be documented based on transthoracic Echocardiographic standards. However, although Echocardiograms 2 days post CABG operation may show abnormalities which is standard in this population, this testing is instrumental because it measures End- diastolic wall thickness and Left ventricular volumes at end-diastole and end-systole. | Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine dose groups to make a comparison to placebo subjects. | Posted | Number | Abnormal Echocardiograms | Day 2 |
|
|
18 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | (1) Lower MSC Dose | Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG001 | (2) Higher MSC Dose | Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery. | 0 | 4 | 2 | 4 | 4 | 4 |
| EG002 | (3) Placebo Injection | Participants will receive placebo injections Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA). | 1 | 3 | 3 | 3 | 2 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block complete | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Large intestine perforation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hypersensitivity | Immune system disorders | Systematic Assessment |
| ||
| Post procedural hemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural site reaction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Transient ischemic attack | Nervous system disorders | Systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Haemothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Debridement | Surgical and medical procedures | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Ischemia | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ileus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chest discomfort | General disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Tenderness | General disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Back Injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Blood triglycerides abnormal | Investigations | Systematic Assessment |
| ||
| Hematocrit decreased | Investigations | Systematic Assessment |
| ||
| Hepatic enzyme increased | Investigations | Systematic Assessment |
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| White blood cell count increased | Investigations | Systematic Assessment |
| ||
| Acidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Fluid overload | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Ageusia | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness postural | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Neuropathy peripheral | Nervous system disorders | Systematic Assessment |
| ||
| Hallucination | Psychiatric disorders | Systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Erection increased | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Exfoliative rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hematoma evacuation | Surgical and medical procedures | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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Limitations due to slow enrollment and premature closure.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Mendizabal | EMMES Corporation | 301-251-1161 | 221 | amendizabal@emmes.com |
| ID | Term |
|---|---|
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
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