Stem Cell Transplantation, Ventricular Dysfunction, Left
Conditions
Keywords
Chronic Ischemic Left Ventricular Dysfunction
Brief summary
The technique of transplanting progenitor cells into a region of damaged myocardium, termed cellular cardiomyoplasty, is a potentially new therapeutic modality designed to replace or repair necrotic, scarred, or dysfunctional myocardium. Ideally, graft cells should be readily available, easy to culture to ensure adequate quantities for transplantation, and able to survive in host myocardium; often a hostile environment of limited blood supply and immunorejection. Whether effective cellular regenerative strategies require that administered cells differentiate into adult cardiomyocytes and couple electromechanically with the surrounding myocardium is increasingly controversial, and recent evidence suggests that this may not be required for effective cardiac repair. Most importantly, transplantation of graft cells should improve cardiac function and prevent adverse ventricular remodeling. To date, a number of candidate cells have been transplanted in experimental models, including fetal and neonatal cardiomyocytes, embryonic stem cell-derived myocytes, tissue engineered contractile grafts, skeletal myoblasts, several cell types derived from adult bone marrow, and cardiac precursors residing within the heart itself. There has been substantial clinical development in the use of whole bone marrow and skeletal myoblast preparations in studies enrolling both post-infarction patients, and patients with chronic ischemic left ventricular dysfunction and heart failure. The effects of bone-marrow derived mesenchymal stem cells (MSCs) have also been studies clinically. Currently, bone marrow or bone marrow-derived cells represent highly promising modality for cardiac repair. The totality of evidence from trials investigating autologous whole bone marrow infusions into patients following myocardial infarction supports the safety of this approach. In terms of efficacy, increases in ejection fraction are reported in the majority of the trials. Chronic ischemic left ventricular dysfunction resulting from heart disease is a common and problematic condition; definitive therapy in the form of heart transplantation is available to only a tiny minority of eligible patients. Cellular cardiomyoplasty for chronic heart failure has been studied less than for acute MI, but represents a potentially important alternative for this disease.
Interventions
BIOLOGICALAutologous human mesenchymal cells (hMSCs)
Participants will receive 40 million cells/mL delivered in either a dose of 0.25 mL per injection for a total of 1 x 108 (100 million) hMSCs x 10 injections or a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
BIOLOGICALAutologous human bone marrow cells (hBMCs)
Participants will receive 40 million cells/mL delivered in either a dose of 0.25 mL per injection for a total of 1 x 108 (100 million) hBMCs x 10 injections or a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
BIOLOGICALPlacebo
Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Sponsors
The Emmes Company, LLC
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of chronic ischemic left ventricular dysfunction secondary to MI. * Be a candidate for cardiac catheterization. * Been treated with appropriate maximal medical therapy for heart failure or post-infarction left ventricular dysfunction. * Ejection fraction less than or equal to 50%. * Able to perform a metabolic stress test.
Exclusion criteria
* Baseline glomerular filtration rate \< 45 ml/min/1.73m2. * Presence of a mechanical aortic valve or heart constrictive device. * Documented presence of aortic stenosis (aortic stenosis graded as ≥+2 equivalent to an orifice area of 1.5cm2 or less). * Documented presence of moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥+2). * Evidence of a life-threatening arrhythmia (nonsustained ventricular tachycardia ≥ 20 consecutive beats or complete heart block) or QTc interval \> 550 ms on screening ECG. In addition; patients with sustained or a short run of ventricular tachycardia on ECG or 48 hour Ambulatory ECG during the screening period will be removed from the protocol. * Documented unstable angina. * AICD firing in the past 60 days prior to the procedure. * Contra-indication to performance of a magnetic resonance imaging scan. * Be eligible for or require coronary artery revascularization. * Have a hematologic abnormality as evidenced by hematocrit \< 25%, white blood cell \< 2,500/ul or platelet values \< 100,000/ul without another explanation. * Have liver dysfunction, as evidenced by enzymes (ALT and AST) greater than three times the ULN. * Have a coagulopathy condition = (INR \> 1.3) not due to a reversible cause. * Known, serious radiographic contrast allergy. * Known allergies to penicillin or streptomycin. * Organ transplant recipient. * Clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma. * Non-cardiac condition that limits lifespan to \< 1 year. * On chronic therapy with immunosuppressant medication. * Serum positive for HIV, hepatitis BsAg, or non-viremic hepatitis C. * Female patient who is pregnant, nursing, or of child-bearing potential and not using effective birth control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation | one month post-catheterization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization). | Measured every 12 hours for the first 48 hours post-catheterization | — |
| Incidence of the Major Adverse Cardiac Events (MACE) Endpoint, Defined as the Composite Incidence of (1) Death, (2) Hospitalization for Heart Failure, or (3) Non-fatal Recurrent MI. | 12 months post-catheterization | — |
| Ectopic Tissue Formation. | 12 months post-catheterization | — |
| Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization). | Measured every 12 hours for the first 48 hours post-catheterization | — |
| Change From Baseline in Distance Walked in Six-minutes (Six-minute Walk Test). | 12 months post-catheterization | Data provided are with respect to the change from baseline at 12-months post-catheterization. |
| Change From Baseline in the Minnesota Living With Heart Failure (MLHF) Questionnaire Total Score. | 12 months post-catheterization | Data provided are with respect to the change from baseline at 12-months post-catheterization. The Minnesota living with heart failure questionnaire uses a 6-point, zero to five, Likert scale. The total score is the sum of the 21 responses. The total score is considered the best measure of how heart failure and treatments impact a patients quality of life. The max score is 105, minimum score is 0. A lower score is considered a better quality of life. |
| Percent Change From Baseline in Scar Mass as a Fraction of Left Ventricle Mass by Cardiac MRI or CT. | 12 Months post-catheterization | Data provided are with respect to the change from baseline at 12-months post-catheterization. |
| Number of Deaths | 12-months post-catheterization | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. | 19 |
| 200 Million Autologous Human Bone Marrow Cells (hBMCs) Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. | 19 |
| Participants Will Receive a Placebo Injection of Phosphate-buf Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. | 21 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Did not receive study product injection. | 3 | 3 | 0 |
Baseline characteristics
| Characteristic | 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Participants Will Receive a Placebo Injection of Phosphate-buf | Total | 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) |
|---|---|---|---|---|
| Age, Continuous | 61.1 years STANDARD_DEVIATION 8.4 | 60.6 years STANDARD_DEVIATION 10.4 | 59.6 years STANDARD_DEVIATION 9.9 | 57.1 years STANDARD_DEVIATION 10.6 |
| Device Automatic implanted cardioverter-defribillator | 10 participants | 8 participants | 28 participants | 10 participants |
| Device Biventricular Pacing | 1 participants | 3 participants | 5 participants | 1 participants |
| Device None | 8 participants | 10 participants | 26 participants | 8 participants |
| Distance Walked in 6-Minutes | 399.6 meters STANDARD_DEVIATION 95 | 388.1 meters STANDARD_DEVIATION 58.4 | 400.6 meters STANDARD_DEVIATION 74.4 | 415.3 meters STANDARD_DEVIATION 67.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 9 Participants | 26 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 12 Participants | 32 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| History of Atrial/Ventricular Arrhythmia No | 15 participants | 15 participants | 44 participants | 14 participants |
| History of Atrial/Ventricular Arrhythmia Yes | 4 participants | 6 participants | 15 participants | 5 participants |
| History of Congestive Heart Failure No | 3 participants | 5 participants | 16 participants | 8 participants |
| History of Congestive Heart Failure Yes | 16 participants | 16 participants | 43 participants | 11 participants |
| History of Coronary Interventions No | 1 participants | 1 participants | 2 participants | 0 participants |
| History of Coronary Interventions Yes | 18 participants | 20 participants | 57 participants | 19 participants |
| History of Diabetes No | 15 participants | 14 participants | 45 participants | 16 participants |
| History of Diabetes Yes | 4 participants | 7 participants | 14 participants | 3 participants |
| History of Hyptertension No | 7 participants | 5 participants | 19 participants | 7 participants |
| History of Hyptertension Yes | 12 participants | 16 participants | 40 participants | 12 participants |
| History of Smoking No | 9 participants | 5 participants | 19 participants | 5 participants |
| History of Smoking Yes | 10 participants | 16 participants | 40 participants | 14 participants |
| Imaging Modality CT | 6 participants | 6 participants | 18 participants | 6 participants |
| Imaging Modality MRI | 13 participants | 15 participants | 41 participants | 13 participants |
| New York Heart Association Class I | 5 participants | 4 participants | 14 participants | 5 participants |
| New York Heart Association Class II | 10 participants | 10 participants | 32 participants | 12 participants |
| New York Heart Association Class III | 4 participants | 4 participants | 10 participants | 2 participants |
| New York Heart Association Class Unknown | 0 participants | 3 participants | 3 participants | 0 participants |
| Peak VO2 | 17.3 mL/kg/min STANDARD_DEVIATION 4.4 | 14.6 mL/kg/min STANDARD_DEVIATION 5.6 | 16.7 mL/kg/min STANDARD_DEVIATION 5 | 18.8 mL/kg/min STANDARD_DEVIATION 3.8 |
| Predicted FEV1 | 83.2 percent STANDARD_DEVIATION 23.2 | 79.1 percent STANDARD_DEVIATION 20.1 | 82.7 percent STANDARD_DEVIATION 19.8 | 86.2 percent STANDARD_DEVIATION 15.7 |
| Qualifying ejection fraction, % | 36.3 percent STANDARD_DEVIATION 11.1 | 33.0 percent STANDARD_DEVIATION 9.6 | 34.9 percent STANDARD_DEVIATION 9.7 | 35.8 percent STANDARD_DEVIATION 8.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 20 Participants | 54 Participants | 16 Participants |
| Region of Enrollment United States | 19 participants | 21 participants | 59 participants | 19 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 4 Participants | 1 Participants |
| Sex: Female, Male Male | 17 Participants | 20 Participants | 55 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 19 | 7 / 19 | 5 / 21 |
| serious Total, serious adverse events | 2 / 19 | 2 / 19 | 3 / 21 |
Outcome results
Primary
Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation
Time frame: one month post-catheterization
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) | Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation | Yes | 0 participants |
| 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) | Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation | No | 19 participants |
| 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation | Yes | 0 participants |
| 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation | No | 19 participants |
| Participants Will Receive a Placebo Injection of Phosphate-buf | Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation | Yes | 0 participants |
| Participants Will Receive a Placebo Injection of Phosphate-buf | Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation | No | 21 participants |
Secondary
Change From Baseline in Distance Walked in Six-minutes (Six-minute Walk Test).
Data provided are with respect to the change from baseline at 12-months post-catheterization.
Time frame: 12 months post-catheterization
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) | Change From Baseline in Distance Walked in Six-minutes (Six-minute Walk Test). | 32.6 meters |
| 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Change From Baseline in Distance Walked in Six-minutes (Six-minute Walk Test). | 16.9 meters |
| Participants Will Receive a Placebo Injection of Phosphate-buf | Change From Baseline in Distance Walked in Six-minutes (Six-minute Walk Test). | 6.3 meters |
Secondary
Change From Baseline in the Minnesota Living With Heart Failure (MLHF) Questionnaire Total Score.
Data provided are with respect to the change from baseline at 12-months post-catheterization. The Minnesota living with heart failure questionnaire uses a 6-point, zero to five, Likert scale. The total score is the sum of the 21 responses. The total score is considered the best measure of how heart failure and treatments impact a patients quality of life. The max score is 105, minimum score is 0. A lower score is considered a better quality of life.
Time frame: 12 months post-catheterization
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) | Change From Baseline in the Minnesota Living With Heart Failure (MLHF) Questionnaire Total Score. | -6.3 units on a scale |
| 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Change From Baseline in the Minnesota Living With Heart Failure (MLHF) Questionnaire Total Score. | -8.2 units on a scale |
| Participants Will Receive a Placebo Injection of Phosphate-buf | Change From Baseline in the Minnesota Living With Heart Failure (MLHF) Questionnaire Total Score. | 0.4 units on a scale |
Secondary
Ectopic Tissue Formation.
Time frame: 12 months post-catheterization
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) | Ectopic Tissue Formation. | Yes | 0 participants |
| 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) | Ectopic Tissue Formation. | No | 19 participants |
| 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Ectopic Tissue Formation. | Yes | 0 participants |
| 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Ectopic Tissue Formation. | No | 19 participants |
| Participants Will Receive a Placebo Injection of Phosphate-buf | Ectopic Tissue Formation. | Yes | 0 participants |
| Participants Will Receive a Placebo Injection of Phosphate-buf | Ectopic Tissue Formation. | No | 21 participants |
Secondary
Incidence of the Major Adverse Cardiac Events (MACE) Endpoint, Defined as the Composite Incidence of (1) Death, (2) Hospitalization for Heart Failure, or (3) Non-fatal Recurrent MI.
Time frame: 12 months post-catheterization
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) | Incidence of the Major Adverse Cardiac Events (MACE) Endpoint, Defined as the Composite Incidence of (1) Death, (2) Hospitalization for Heart Failure, or (3) Non-fatal Recurrent MI. | Yes | 1 participants |
| 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) | Incidence of the Major Adverse Cardiac Events (MACE) Endpoint, Defined as the Composite Incidence of (1) Death, (2) Hospitalization for Heart Failure, or (3) Non-fatal Recurrent MI. | No | 18 participants |
| 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Incidence of the Major Adverse Cardiac Events (MACE) Endpoint, Defined as the Composite Incidence of (1) Death, (2) Hospitalization for Heart Failure, or (3) Non-fatal Recurrent MI. | Yes | 0 participants |
| 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Incidence of the Major Adverse Cardiac Events (MACE) Endpoint, Defined as the Composite Incidence of (1) Death, (2) Hospitalization for Heart Failure, or (3) Non-fatal Recurrent MI. | No | 19 participants |
| Participants Will Receive a Placebo Injection of Phosphate-buf | Incidence of the Major Adverse Cardiac Events (MACE) Endpoint, Defined as the Composite Incidence of (1) Death, (2) Hospitalization for Heart Failure, or (3) Non-fatal Recurrent MI. | Yes | 2 participants |
| Participants Will Receive a Placebo Injection of Phosphate-buf | Incidence of the Major Adverse Cardiac Events (MACE) Endpoint, Defined as the Composite Incidence of (1) Death, (2) Hospitalization for Heart Failure, or (3) Non-fatal Recurrent MI. | No | 19 participants |
Secondary
Number of Deaths
Time frame: 12-months post-catheterization
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) | Number of Deaths | Yes | 1 participants |
| 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) | Number of Deaths | No | 18 participants |
| 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Number of Deaths | Yes | 0 participants |
| 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Number of Deaths | No | 19 participants |
| Participants Will Receive a Placebo Injection of Phosphate-buf | Number of Deaths | Yes | 1 participants |
| Participants Will Receive a Placebo Injection of Phosphate-buf | Number of Deaths | No | 20 participants |
Secondary
Percent Change From Baseline in Scar Mass as a Fraction of Left Ventricle Mass by Cardiac MRI or CT.
Data provided are with respect to the change from baseline at 12-months post-catheterization.
Time frame: 12 Months post-catheterization
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) | Percent Change From Baseline in Scar Mass as a Fraction of Left Ventricle Mass by Cardiac MRI or CT. | -18.9 percent change |
| 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Percent Change From Baseline in Scar Mass as a Fraction of Left Ventricle Mass by Cardiac MRI or CT. | -7.0 percent change |
| Participants Will Receive a Placebo Injection of Phosphate-buf | Percent Change From Baseline in Scar Mass as a Fraction of Left Ventricle Mass by Cardiac MRI or CT. | -5.2 percent change |
Secondary
Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization).
Time frame: Measured every 12 hours for the first 48 hours post-catheterization
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) | Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization). | 36-hours post-catheterization | 1.38 ng/mL |
| 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) | Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization). | 24-hours post-catheterization | 2.19 ng/mL |
| 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) | Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization). | Baseline | 1.61 ng/mL |
| 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) | Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization). | 12-hours post-catheterization | 3.75 ng/mL |
| 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) | Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization). | 48-hours post-catheterization | 1.05 ng/mL |
| 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization). | 24-hours post-catheterization | 1.73 ng/mL |
| 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization). | Baseline | 1.36 ng/mL |
| 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization). | 12-hours post-catheterization | 2.98 ng/mL |
| 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization). | 36-hours post-catheterization | 1.28 ng/mL |
| 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization). | 48-hours post-catheterization | 1.03 ng/mL |
| Participants Will Receive a Placebo Injection of Phosphate-buf | Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization). | 48-hours post-catheterization | 1.36 ng/mL |
| Participants Will Receive a Placebo Injection of Phosphate-buf | Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization). | 36-hours post-catheterization | 1.63 ng/mL |
| Participants Will Receive a Placebo Injection of Phosphate-buf | Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization). | Baseline | 1.64 ng/mL |
| Participants Will Receive a Placebo Injection of Phosphate-buf | Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization). | 24-hours post-catheterization | 2.85 ng/mL |
| Participants Will Receive a Placebo Injection of Phosphate-buf | Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization). | 12-hours post-catheterization | 4.41 ng/mL |
Secondary
Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization).
Time frame: Measured every 12 hours for the first 48 hours post-catheterization
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) | Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization). | 36-hours post-catheterization | 0.39 ng/mL |
| 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) | Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization). | 24-hours post-catheterization | 0.60 ng/mL |
| 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) | Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization). | Baseline | 0.06 ng/mL |
| 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) | Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization). | 12-hours post-catheterization | 0.82 ng/mL |
| 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) | Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization). | 48-hours post-catheterization | 0.31 ng/mL |
| 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization). | 24-hours post-catheterization | 0.45 ng/mL |
| 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization). | Baseline | 0.06 ng/mL |
| 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization). | 12-hours post-catheterization | 1.03 ng/mL |
| 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization). | 36-hours post-catheterization | 0.29 ng/mL |
| 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization). | 48-hours post-catheterization | 0.25 ng/mL |
| Participants Will Receive a Placebo Injection of Phosphate-buf | Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization). | 48-hours post-catheterization | 0.22 ng/mL |
| Participants Will Receive a Placebo Injection of Phosphate-buf | Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization). | 36-hours post-catheterization | 0.31 ng/mL |
| Participants Will Receive a Placebo Injection of Phosphate-buf | Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization). | Baseline | 0.11 ng/mL |
| Participants Will Receive a Placebo Injection of Phosphate-buf | Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization). | 24-hours post-catheterization | 0.42 ng/mL |
| Participants Will Receive a Placebo Injection of Phosphate-buf | Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization). | 12-hours post-catheterization | 0.98 ng/mL |