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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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This is a 16 subject trial to demonstrate the safety of allogeneic hMSCs administered via infusion therapy for diabetic subjects with endothelial dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilot Phase 20 million allogeneic hMSCs | Experimental | Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs) |
|
| Pilot Phase 100 million hMSCs | Experimental | Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs) |
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| Randomized Phase 20 million allogeneic hMSCs | Experimental | Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs) |
|
| Randomized Phase 100 million allogeneic hMSCs | Experimental | Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20 million Allogeneic Mesenchymal Human Stem Cells | Drug | 1 single intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Emergent Serious Adverse Events (TE-SAEs) | TE-SAEs as evaluated by the investigator which may include but not limited to: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities. | Up to one month (post infusion) |
| Measure | Description | Time Frame |
|---|---|---|
| EPC-CFU Levels | Endothelial Progenitor Cell Colony Forming Units (EPC-CFU) will be assessed from blood samples | At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365 |
| CRP Marker Levels |
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Inclusion Criteria:
Exclusion Criteria:
In order to participate in this study, a subject Must Not:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua M Hare, MD | ISCI / University of Miami Miller School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
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| Label | URL |
|---|---|
| Interdisciplinary stem cell institute at the University of Miami website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pilot Phase 20 Million Allogeneic hMSCs | Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs) 20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion |
| FG001 | Pilot Phase 100 Million hMSCs |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment |
|
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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 | Oct 26, 2020 |
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Pilot phase is open label. Randomized phase is blinded.
|
| 100 million Allogeneic Mesenchymal Human Stem Cells | Drug | 1 single intravenous infusion |
|
|
C-Reactive Protein (CRP) levels will be assessed from blood samples and reported in mg/L
| At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365 |
| Circulating Angiogenic Factor Levels | Circulating Angiogenic Factor levels including Vascular Endothelial Growth Factor (VEGF), Stem Cell Factor (SCF) and Stromal Cell-Derived Factor 1 (SDF-1) will be assessed from blood samples and reported in ng/mL | At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365 |
| Flow Mediated Diameter Percentage (FMD%) | FMD will be assessed using brachial artery ultrasound | At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365 |
| Circulating Inflammatory Marker Levels | Circulating inflammatory marker levels including Interleukin (IL) -1 and IL-6 will be assessed from blood samples and reported in pg/mL | At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365 |
| Tumor Necrosis Factor (TNF) Alpha Levels | Measured from blood samples (pg/mL) | At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365 |
Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs) 100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion |
| FG002 | Randomized Phase 20 Million Allogeneic hMSCs | Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs) 20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion |
| FG003 | Randomized Phase 100 Million Allogeneic hMSCs | Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs) 100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion |
| COMPLETED |
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| NOT COMPLETED |
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| Follow-up |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pilot Phase 20 Million Allogeneic hMSCs | Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs) 20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion |
| BG001 | Pilot Phase 100 Million hMSCs | Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs) 100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion |
| BG002 | Randomized Phase 20 Million Allogeneic hMSCs | Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs) 20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion |
| BG003 | Randomized Phase 100 Million Allogeneic hMSCs | Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs) 100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion |
| BG004 | 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| 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 | Number of Treatment Emergent Serious Adverse Events (TE-SAEs) | TE-SAEs as evaluated by the investigator which may include but not limited to: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities. | Posted | Number | Treatment Emergent SAE | Up to one month (post infusion) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | EPC-CFU Levels | Endothelial Progenitor Cell Colony Forming Units (EPC-CFU) will be assessed from blood samples | Not all participants completed required blood draw at each timepoint. | Posted | Mean | Standard Deviation | Colony forming units | At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | CRP Marker Levels | C-Reactive Protein (CRP) levels will be assessed from blood samples and reported in mg/L | Blood samples were collected. However, due to cost and logistical reasons, the samples were not analyzed and hence no data were generated | Posted | At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Circulating Angiogenic Factor Levels | Circulating Angiogenic Factor levels including Vascular Endothelial Growth Factor (VEGF), Stem Cell Factor (SCF) and Stromal Cell-Derived Factor 1 (SDF-1) will be assessed from blood samples and reported in ng/mL | Blood samples were collected. However, due to cost and logistical reasons, the samples were not analyzed and hence no data were generated | Posted | At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Flow Mediated Diameter Percentage (FMD%) | FMD will be assessed using brachial artery ultrasound | Not all participants completed the brachial artery ultrasound at each timepoint. | Posted | Mean | Standard Deviation | Percent dilation of brachial artery | At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Circulating Inflammatory Marker Levels | Circulating inflammatory marker levels including Interleukin (IL) -1 and IL-6 will be assessed from blood samples and reported in pg/mL | Blood samples were collected. However, due to cost and logistical reasons, the samples were not analyzed and hence no data were generated | Posted | At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Tumor Necrosis Factor (TNF) Alpha Levels | Measured from blood samples (pg/mL) | Not all participants completed required blood draw at each timepoint. | Posted | Mean | Standard Deviation | pg/mL | At Baseline, Day 3, Day 7, Day 14, Day 28, Day 90, Day 180, Day 365 |
|
12 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 | Pilot Phase 20 Million Allogeneic hMSCs | Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs) 20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion | 0 | 3 | 1 | 3 | 2 | 3 |
| EG001 | Pilot Phase 100 Million hMSCs | Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs) 100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion | 0 | 3 | 1 | 3 | 2 | 3 |
| EG002 | Randomized Phase 20 Million Allogeneic hMSCs | Participants in this group will receive one peripheral intravenous infusion of 20 million allogeneic Mesenchymal Human Stem Cells (hMSCs) 20 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion | 0 | 5 | 0 | 5 | 5 | 5 |
| EG003 | Randomized Phase 100 Million Allogeneic hMSCs | Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs) 100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion | 0 | 5 | 1 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | Cardiac disorders | Systematic Assessment |
| ||
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Removal of left lung nodule |
| |
| Gastrointestinal Stromal Tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Abdominal Surgical Site Infection | Infections and infestations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Elevated White Blood Cells with Neutrophilia | Blood and lymphatic system disorders | Systematic Assessment |
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| Chest Pain | Cardiac disorders | Systematic Assessment |
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| Incomplete Right bundle branch block | Cardiac disorders | Systematic Assessment |
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| Corneal Edema, Deterioration of vision | Eye disorders | Systematic Assessment |
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| Gastroesophogeal Reflux Disease Exacerbation | Gastrointestinal disorders | Systematic Assessment |
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| Recurrence of Gastrointestinal bleed | Gastrointestinal disorders | Systematic Assessment |
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| Allergic Reaction to Flu shot | Immune system disorders | Systematic Assessment |
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| Mild allergic reaction | Immune system disorders | Systematic Assessment |
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| Genital Herpes Simplex | Infections and infestations | Systematic Assessment |
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| Upper Respiratory Infection | Infections and infestations | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
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| Viral Illness | Infections and infestations | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Motor Vehicle Accident | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hypercalcemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Poor Diabetes Control | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Left Distal fibula fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Right Shoulder Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Abnormal Urinalysis | Renal and urinary disorders | Systematic Assessment |
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| Leukocyturia | Renal and urinary disorders | Systematic Assessment |
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| Proteinurea | Renal and urinary disorders | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
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| Cervical Intraepithelial Neoplasia 1, Mild Dysplasia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Dry Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Bullous Pemphigoid | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin Irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joshua M. Hare, MD | University of Miami | 305-243-5579 | jhare@med.miami.edu |
| Dec 3, 2021 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System 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 |
|
| OG003 |
| Randomized Phase 100 Million Allogeneic hMSCs |
Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs) 100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion |
|
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| OG003 |
| Randomized Phase 100 Million Allogeneic hMSCs |
Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs) 100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion |
|
| OG003 | Randomized Phase 100 Million Allogeneic hMSCs | Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs) 100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion |
|
| OG003 | Randomized Phase 100 Million Allogeneic hMSCs | Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs) 100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion |
|
|
| OG003 | Randomized Phase 100 Million Allogeneic hMSCs | Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs) 100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion |
|
| Randomized Phase 100 Million Allogeneic hMSCs |
Participants in this group will receive one peripheral intravenous infusion of 100 million allogeneic Mesenchymal Human Stem Cells (hMSCs) 100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion |
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