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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL134558-01 | 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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The purpose of this study is to test the hypothesis that allogeneic Mesenchymal Stem Cells (MSCs) promote systemic and coronary endothelial repair through rescue of bone marrow progenitors in type 2 diabetic patients with symptomatic IHD compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group | Experimental | Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million). |
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| Group B: Placebo Group | Placebo Comparator | Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 100 million Allogeneic Mesenchymal Human Stem Cells | Drug | 1 single intravenous infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Brachial Artery Flow Mediated Diameter Percentage (FMD%) | FMD% is measured via brachial artery ultrasound. The unit of measure is percent. | Baseline, Week 2, Month 1, Month 3, and Month 6 |
| EPC-CFU Counts | Endothelial progenitor cells (EPC)-colony forming units (CFUs) will be assessed from blood samples. The unit of measure is the average number of colonies per well. | Baseline, Week 2, Month 1, Month 3, and Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Fractional Flow Reserve (FFR) | Fractional Flow Reserve as assessed by during cardiac catheterization angiography. The values are presented as a ratio. | Baseline, Month 6 |
| Coronary Flow Reserve (CFR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nikolaos Spilias, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| Label | URL |
|---|---|
| Description: Interdisciplinary Stem Cell Institute at the University of Miami Miller School website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group | Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million). 100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 8, 2025 |
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| Placebo | Other | Placebo delivered via peripheral intravenous infusion |
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Coronary Flow Reserve as assessed by during cardiac catheterization angiography. The values are presented as a ratio.
| Baseline, Month 6 |
| Seattle Angina Questionnaire (SAQ) Angina Frequency (AF) | SAQ is a 7 item questionnaire with a total score ranging from 0-100 with the higher scores indicating less physical limitations, less angina, symptom frequency and better quality of life. The unit of measure is score on a scale. | Baseline, Week 2, Month 1, Month 3, and Month 6 |
| Seattle Angina Questionnaire (SAQ) Quality of Life (QL) | SAQ is a 7 item questionnaire with a total score ranging from 0-100 with the higher scores indicating less physical limitations, less angina, symptom frequency and better quality of life. The unit of measure is score on a scale. | Baseline, Week 2, Month 1, Month 3, and Month 6 |
| Number of Participants With Treatment-Emergent Serious Adverse Events (TE-SAE) | TE-SAEs will be defined as the composite of: death, non-fatal myocardial infarction (MI), stroke, hospitalization for heart failure, sustained ventricular arrhythmias (characterized by ventricular arrhythmias lasting longer than 30 sec or with hemodynamic compromise) or atrial fibrillation at 1 month post-infusion. TE-SAEs will be assessed by treating physician. The unit of measurement is the number of participants who experienced an event. | 1 month post infusion |
| Number of Participants With Major Adverse Cardiac Events (MACE) | Defined as the composite incidence of (1) death, (2) hospitalization for cardiovascular events or (3) non-fatal myocardial infarction MI at 1 year. MACE will be assessed by treating physician. The unit of measurement is the number of participants who experienced an event. | 12 months |
| Number of Participants With Target Vessel Failure | Number of participants with target vessel failure will be reported. Target vessel failure is defined as any participant that encounters revascularization, death, or MI attributed to the target vessel post-PCI (percutaneous coronary intervention). The unit of measure is number of participants. | 12 months |
| Number of Participants With Treatment Emergent Adverse Events | The number of participants who experienced a Treatment Emergent Adverse Event (AE), as assessed by study physician, will be reported. The unit of measurement is the number of participants who experienced an event. | 12 months |
| Number of Participants With Abnormal Lab Values | Number of participants with clinically significant abnormal serum hematology and clinical chemistry values will be reported. Clinical significance will be assessed by treating physician. The unit of measure is number of participants. | 12 months |
| Circulating Angiogenic Marker - VEGF | Vascular Endothelial Growth Factor (VEGF) levels from serum samples. Results are provided in units of pg/mL. Higher levels of VEGF are associated with better cardiovascular health. | Baseline, Month 1, Month 3, Month 6 |
| Circulating Cytokine Biomarker - TNFα | Circulating Tumor necrosis factor alpha (TNFα) levels from serum samples. Results are provided in units of pg/mL. Lower values are associated with reduced inflammation. | Baseline, Month 1, Month 3, Month 6 |
| Group B: Placebo Group |
Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion. Placebo: Placebo delivered via peripheral intravenous infusion |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group | Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million). 100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion |
| BG001 | Group B: Placebo Group | Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion. Placebo: Placebo delivered via peripheral intravenous infusion |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Brachial Artery Flow Mediated Diameter Percentage (FMD%) | FMD% is measured via brachial artery ultrasound. The unit of measure is percent. | Two subjects (1 in each group) were lost to follow up before completing the study. | Posted | Mean | Standard Deviation | percentage | Baseline, Week 2, Month 1, Month 3, and Month 6 |
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| ||||||||||||||||||||||||||||
| Primary | EPC-CFU Counts | Endothelial progenitor cells (EPC)-colony forming units (CFUs) will be assessed from blood samples. The unit of measure is the average number of colonies per well. | The number of subjects analyzed are less than the overall totals because the EPC-CFU assay protocol was altered midway through the trial; therefore, only a sub-set of subjects have complete data for this assay. | Posted | Median | Inter-Quartile Range | CFUs per well | Baseline, Week 2, Month 1, Month 3, and Month 6 |
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| Secondary | Fractional Flow Reserve (FFR) | Fractional Flow Reserve as assessed by during cardiac catheterization angiography. The values are presented as a ratio. | Few subjects from either group did not have cardiac catheterization at baseline, or were lost to follow up before the Month 6 catheterization. | Posted | Mean | Standard Deviation | ratio | Baseline, Month 6 |
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| Secondary | Coronary Flow Reserve (CFR) | Coronary Flow Reserve as assessed by during cardiac catheterization angiography. The values are presented as a ratio. | Few subjects from either group did not have cardiac catheterization at baseline, or were lost to follow up before the Month 6 catheterization. | Posted | Mean | Standard Deviation | ratio | Baseline, Month 6 |
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| Secondary | Seattle Angina Questionnaire (SAQ) Angina Frequency (AF) | SAQ is a 7 item questionnaire with a total score ranging from 0-100 with the higher scores indicating less physical limitations, less angina, symptom frequency and better quality of life. The unit of measure is score on a scale. | Two subjects (1 in each group) were lost to follow up before completing the study. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 2, Month 1, Month 3, and Month 6 |
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| Secondary | Seattle Angina Questionnaire (SAQ) Quality of Life (QL) | SAQ is a 7 item questionnaire with a total score ranging from 0-100 with the higher scores indicating less physical limitations, less angina, symptom frequency and better quality of life. The unit of measure is score on a scale. | Two subjects (1 in each group) were lost to follow up before completing the study. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 2, Month 1, Month 3, and Month 6 |
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| Secondary | Number of Participants With Treatment-Emergent Serious Adverse Events (TE-SAE) | TE-SAEs will be defined as the composite of: death, non-fatal myocardial infarction (MI), stroke, hospitalization for heart failure, sustained ventricular arrhythmias (characterized by ventricular arrhythmias lasting longer than 30 sec or with hemodynamic compromise) or atrial fibrillation at 1 month post-infusion. TE-SAEs will be assessed by treating physician. The unit of measurement is the number of participants who experienced an event. | Posted | Count of Participants | Participants | 1 month post infusion |
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| Secondary | Number of Participants With Major Adverse Cardiac Events (MACE) | Defined as the composite incidence of (1) death, (2) hospitalization for cardiovascular events or (3) non-fatal myocardial infarction MI at 1 year. MACE will be assessed by treating physician. The unit of measurement is the number of participants who experienced an event. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Number of Participants With Target Vessel Failure | Number of participants with target vessel failure will be reported. Target vessel failure is defined as any participant that encounters revascularization, death, or MI attributed to the target vessel post-PCI (percutaneous coronary intervention). The unit of measure is number of participants. | This analysis only includes participants with obstructive CAD (coronary artery disease) at baseline who required stent placement. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events | The number of participants who experienced a Treatment Emergent Adverse Event (AE), as assessed by study physician, will be reported. The unit of measurement is the number of participants who experienced an event. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Number of Participants With Abnormal Lab Values | Number of participants with clinically significant abnormal serum hematology and clinical chemistry values will be reported. Clinical significance will be assessed by treating physician. The unit of measure is number of participants. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Circulating Angiogenic Marker - VEGF | Vascular Endothelial Growth Factor (VEGF) levels from serum samples. Results are provided in units of pg/mL. Higher levels of VEGF are associated with better cardiovascular health. | Two subjects (1 in each group) were lost to follow up before completing the study. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Month 1, Month 3, Month 6 |
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| Secondary | Circulating Cytokine Biomarker - TNFα | Circulating Tumor necrosis factor alpha (TNFα) levels from serum samples. Results are provided in units of pg/mL. Lower values are associated with reduced inflammation. | Two subjects (1 in each group) were lost to follow up before completing the study. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Month 1, Month 3, Month 6 |
|
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1 year
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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 | Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group | Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million). 100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion | 0 | 13 | 2 | 13 | 11 | 13 |
| EG001 | Group B: Placebo Group | Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion. Placebo: Placebo delivered via peripheral intravenous infusion | 0 | 13 | 4 | 13 | 9 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment |
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| Acute Coronary Syndrome | Cardiac disorders | Non-systematic Assessment |
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| Cardiac Chest Pain | Cardiac disorders | Non-systematic Assessment |
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| Heart Failure Exacerbation | Cardiac disorders | Non-systematic Assessment |
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| Non-Cardiac Chest Pain | General disorders | Non-systematic Assessment |
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| Lung Infection | Infections and infestations | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Carotid Artery Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Increased Creatinine | Investigations | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Myasthenia gravis | Nervous system disorders | Non-systematic Assessment |
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| Syncope | Nervous system disorders | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Peripheral Ischemia | Vascular disorders | Non-systematic Assessment |
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| Thromboembolism | Vascular disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Bilateral Axillary Adenopathy | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Atrial Flutter | Cardiac disorders | Non-systematic Assessment |
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| Cardiac Chest Pain | Cardiac disorders | Non-systematic Assessment |
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| Heart Failiure Exacerbation | Cardiac disorders | Non-systematic Assessment |
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| In stent re-stenosis | Cardiac disorders | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | Non-systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
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| Left Eye Diplopia | Eye disorders | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
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| Dental caries | Gastrointestinal disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Edema Limbs | General disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Non-Cardiac Chest Pain | General disorders | Non-systematic Assessment |
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| Vaccination Site Lymphadenopathy | General disorders | Non-systematic Assessment |
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| Hepatobiliary disease | Hepatobiliary disorders | Non-systematic Assessment |
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| Lung Infection | Infections and infestations | Non-systematic Assessment |
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| Nail Infection | Infections and infestations | Non-systematic Assessment |
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| Upper respiratory infection | Infections and infestations | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Prolonged APTT | Investigations | Non-systematic Assessment |
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| Alkaline phosphatase increased | Investigations | Non-systematic Assessment |
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| AST increased | Investigations | Non-systematic Assessment |
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| Creatinine increased | Investigations | Non-systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Prostate carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Concentration impairment | Nervous system disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Myasthenia gravis | Nervous system disorders | Non-systematic Assessment |
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| Paresthesia | Nervous system disorders | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | Non-systematic Assessment |
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| Renal calculi | Renal and urinary disorders | Non-systematic Assessment |
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| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Skin Burn | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Arterial thromboembolism | Vascular disorders | Non-systematic Assessment |
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| Peripheral ischemia | Vascular disorders | Non-systematic Assessment |
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| Worsening Peripheral Disease | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua M. Hare, MD | University of Miami, Miller School of Medicine - Interdisciplinary Stem Cell Institute (ISCI) | 305-243-5579 | jhare@med.miami.edu |
| Feb 18, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 8, 2025 | Feb 18, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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