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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL110737 | U.S. NIH Grant/Contract | View source | |
| R01HL107110 | U.S. NIH Grant/Contract | View source | |
| R01HL084275 | U.S. NIH Grant/Contract | View source | |
| P20HL101443 | U.S. NIH Grant/Contract | View source | |
| R01HL094849 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| The Emmes Company, LLC | INDUSTRY |
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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 studied 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auto-hMSCs | Experimental | Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells. |
|
| Allo-hMSCs | Experimental | Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auto-hMSCs | Biological | Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| CT Infarct Size From Early Enhanced Defect: - Difference Between the Baseline and 13-month | Percentage change from 13-months post-catheterization to baseline. | Baseline Month 13 post-catheterization |
| CT Measure of Left Ventricular Ejection Fraction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua M Hare, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Miller School of Medicine | Miami | Florida | United States | |||
| Johns Hopkins University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23117550 | Result | Hare JM, Fishman JE, Gerstenblith G, DiFede Velazquez DL, Zambrano JP, Suncion VY, Tracy M, Ghersin E, Johnston PV, Brinker JA, Breton E, Davis-Sproul J, Schulman IH, Byrnes J, Mendizabal AM, Lowery MH, Rouy D, Altman P, Wong Po Foo C, Ruiz P, Amador A, Da Silva J, McNiece IK, Heldman AW, George R, Lardo A. Comparison of allogeneic vs autologous bone marrow-derived mesenchymal stem cells delivered by transendocardial injection in patients with ischemic cardiomyopathy: the POSEIDON randomized trial. JAMA. 2012 Dec 12;308(22):2369-79. doi: 10.1001/jama.2012.25321. | |
| 30005555 |
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One patient did not receive Autologous MSCs because they became ineligible.
Participants were enrolled between April 2, 2010 and September 14, 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Allo-hMSCs | Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells. Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. |
| FG001 | Auto-hMSCs | Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells. Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Allo-hMSCs | Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells. Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | 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 | Posted | Number | 95% Confidence Interval | percentage of participants | One month post-catheterization |
|
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Adverse events are shown by organ system.
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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 | Allo-hMSCs | Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells. Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Disorders | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cardiac disorder | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Mendizabal | The EMMES Corporation | 301 251 1161 | 221 | amendizabal@emmes.com |
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|
| Allo-hMSCs | Biological | Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. |
|
| Baseline Month 13 post-catheterization |
| CT Measure of End Diastolic Volume | Baseline Month 13 post-catheterization |
| CT Measure of End Systolic Volume | Baseline Month 13 post-catheterization |
| CT Measure of Scar Size as % of LV Mass | Baseline Month 13 post-catheterization |
| Change in Distance Walked in 6-minutes From Baseline. | 12-months |
| Change in Minnesota Living With Heart Failure Total Score | 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. | 12 months |
| Change in New York Heart Association Class at 12-months | 12 months |
| Baltimore |
| Maryland |
| United States |
| Derived |
| Tompkins BA, Rieger AC, Florea V, Banerjee MN, Natsumeda M, Nigh ED, Landin AM, Rodriguez GM, Hatzistergos KE, Schulman IH, Hare JM. Comparison of Mesenchymal Stem Cell Efficacy in Ischemic Versus Nonischemic Dilated Cardiomyopathy. J Am Heart Assoc. 2018 Jul 12;7(14):e008460. doi: 10.1161/JAHA.117.008460. |
| BG001 | Auto-hMSCs | Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells. Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Auto-hMSCs | Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells. Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. |
|
|
|
| Secondary | CT Infarct Size From Early Enhanced Defect: - Difference Between the Baseline and 13-month | Percentage change from 13-months post-catheterization to baseline. | Posted | Mean | 95% Confidence Interval | percent change from baseline | Baseline Month 13 post-catheterization |
|
|
|
|
| Secondary | CT Measure of Left Ventricular Ejection Fraction | Posted | Mean | 95% Confidence Interval | percent | Baseline Month 13 post-catheterization |
|
|
|
|
| Secondary | CT Measure of End Diastolic Volume | Posted | Mean | 95% Confidence Interval | ml | Baseline Month 13 post-catheterization |
|
|
|
|
| Secondary | CT Measure of End Systolic Volume | Posted | Mean | 95% Confidence Interval | ml | Baseline Month 13 post-catheterization |
|
|
|
|
| Secondary | CT Measure of Scar Size as % of LV Mass | Posted | Mean | 95% Confidence Interval | percent | Baseline Month 13 post-catheterization |
|
|
|
|
| Secondary | Change in Distance Walked in 6-minutes From Baseline. | Posted | Mean | 95% Confidence Interval | meters | 12-months |
|
|
|
|
| Secondary | Change in Minnesota Living With Heart Failure Total Score | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 months |
|
|
|
|
| Secondary | Change in New York Heart Association Class at 12-months | Posted | Number | participants | 12 months |
|
|
|
|
| 5 |
| 15 |
| 10 |
| 15 |
| EG001 | Auto-hMSCs | Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells. Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. | 8 | 15 | 11 | 15 |
| Nervous System Disorder | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Renal and Urinary Disorders | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Respiratory, Thoracic, and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Infections and infestations | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Surgical and Medical Procedure | Surgical and medical procedures | MedDRA 10.0 | Non-systematic Assessment |
|
| Vascular Disorders | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Eye Disorders | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| General disorders and administration site conditions | General disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Infections and infestations | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Musculoskeletal and connective issue disorders | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Nervous System Disorders | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Renal and urinary disorders | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Skin and subcutaneous disorders | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| vascular disorders | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
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| Worsened NYHA Class |
|