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COVID-19 Pandemic and lack of funding
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| Name | Class |
|---|---|
| The Marcus Foundation | OTHER |
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This study is to compare the safety and efficacy of UCMSCs and BMMSCs administered intravenously in patients to evaluate cytokine suppression in patients with chronic inflammation. Cells administered via intravenous infusion (IV) and will be tested in 37 patients in two phases (Pilot and Randomized).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilot Phase: Group 1 (UCMSCs - 20 million) | Experimental | Three (3) subjects will be treated with a single administration of 2 x 10^7 (20 million) UCMSCs delivered via peripheral intravenous infusion. |
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| Pilot Phase: Group 3 (UCMSCs - 100 million) | Experimental | Three (3) subjects will be treated with a single IV administration of 1 x 10^8 (100 million) UCMSCs delivered via peripheral intravenous infusion. |
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| Pilot Phase: Group 2 (BMMSCs - 20 million) | Experimental | Three (3) subjects will be treated with a single IV administration of 2 x 10^7 (20 million) BMMSCs delivered via peripheral intravenous infusion. |
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| Pilot Phase: Group 4 (BMMSCs -100 million) | Experimental | Three (3) subjects will be treated with a single IV administration of 1 x 10^8 (100 million) BMMSCs delivered via peripheral intravenous infusion. |
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| Group A (UCMSCs - 100 million) | Experimental | Participants randomized to receive a single administration of 1 x 10^8 (100 million) UCMSCs delivered via peripheral intravenous infusion. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCMSCs | Biological | Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment-Emergent Serious Adverse Events (TE-SAEs) | Number of treatment-emergent serious adverse events (SAE) (at one-month post infusion), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities, determined per the Investigator's judgment. | one month post infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Cytokine Levels | Cytokine levels including the following panel of inflammatory and angiogenic markers: Interleukin-1 (IL-1), Interleukin-6 (IL-6), Tumor Necrosis Factor alpha (TNFα), and Vascular Endothelial Growth Factor (VEGF), & Stromal Cell Derived Factor (SDF-1a) levels from serum/plasma samples all measured in pg/mL. | at Baseline, at Week 2, at Month 1, at Month 3, and at Month 6 |
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Inclusion Criteria:
Endothelial dysfunction Criteria:
Impaired flow-mediated vasodilation (FMD <7%)
• At the time of enrollment, each subject must meet at least 3 out of the 5 criteria under the harmonized definition of the metabolic syndrome, consisting of the following:
Exclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| ISCI / 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 Miller School website | View source |
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No subjects had been randomized to Group A or C at the time of trial termination.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pilot Phase: Group 1 (UCMSCs - 20 Million) | Three (3) subjects will be treated with a single administration of 2 x 10^7 (20 million) UCMSCs delivered via peripheral intravenous infusion. UCMSCs: Allogeneic Umbilical Cord Tissue derived Mesenchymal Stem Cells (MSC). |
| FG001 | Pilot Phase: Group 2 (BMMSCs - 20 Million) | Three (3) subjects will be treated with a single IV administration of 2 x 10^7 (20 million) BMMSCs delivered via peripheral intravenous infusion. BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs) |
| FG002 | Pilot Phase: Group 3 (UCMSCs - 100 Million) | Three (3) subjects will be treated with a single IV administration of 1 x 10^8 (100 million) UCMSCs delivered via peripheral intravenous infusion. UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs) |
| FG003 | Pilot Phase: Group 4 (BMMSCs -100 Million) | Three (3) subjects will be treated with a single IV administration of 1 x 10^8 (100 million) BMMSCs delivered via peripheral intravenous infusion. BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs) |
| FG004 | Group A (UCMSCs - 100 Million) | Participants randomized to receive a single administration of 1 x 10^8 (100 million) UCMSCs delivered via peripheral intravenous infusion. UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs) |
| FG005 | Group B (BMMSCs - 100 Million) | Participants randomized to receive a single administration of 1 x 10^8 (100 million) BMMSC delivered via peripheral intravenous infusion. BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs) |
| FG006 | Group C (Placebo) | Participants randomized to receive a single administration of placebo via peripheral intravenous infusion. Placebo: a single administration of placebo delivered via peripheral intravenous infusion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Randomized phase of the study was terminated after only 2 participants. No subjects were allocated to Group A or Group C in the randomized phase of the trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pilot Phase: Group 1 (UCMSCs - 20 Million) | Three (3) subjects will be treated with a single administration of 2 x 10^7 (20 million) UCMSCs delivered via peripheral intravenous infusion. UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs) |
| BG001 | Pilot Phase: Group 2 (BMMSCs - 20 Million) |
| 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 |
| 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) | Number of treatment-emergent serious adverse events (SAE) (at one-month post infusion), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities, determined per the Investigator's judgment. | No subjects had been randomized to Group A or C at the time of trial termination. | Posted | Number | Events | one month post infusion |
|
1 year
No subjects had been randomized to Group A or C at the time of trial termination.
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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: Group 1 (UCMSCs - 20 Million) | Three (3) subjects will be treated with a single administration of 2 x 10^7 (20 million) UCMSCs delivered via peripheral intravenous infusion. UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Esophageal Perforation | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
Funding timeline was not met due to the coronavirus disease 2019 (COVID-19) pandemic. No additional funding was provided, therefore the study had to be terminated early.
| 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 |
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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 22, 2020 | Sep 29, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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Pilot phase is open-label. Randomized phase is blinded.
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| Group B (BMMSCs - 100 million) | Experimental | Participants randomized to receive a single administration of 1 x 10^8 (100 million) BMMSC delivered via peripheral intravenous infusion. |
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| Group C (Placebo) | Placebo Comparator | Participants randomized to receive a single administration of placebo via peripheral intravenous infusion. |
|
| BMMSCs | Biological | Bone Marrow derived Mesenchymal Stem Cells (BMMSCs) |
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| Placebo | Other | a single administration of placebo delivered via peripheral intravenous infusion. |
|
| hsCRP Levels | values at baseline and follow up for the following inflammatory marker: Serum High sensitivity C-Reactive Protein (hsCRP) in mg/L. | at Baseline, at Week 2, at Month 1, at Month 3, and at Month 6 |
| Stem Cell Factor (SCF) Levels | SCF levels from serum/plasma samples measured in units of mg/mL | at Baseline, at Week 2, at Month 1, at Month 3, and at Month 6 |
| Endothelial Progenitor Cell-Colony Forming Units (EPC-CFUs) | Endothelial function will be reported as the change in Endothelial Progenitor Cell Colony Forming Unit (EPC-CFU) assessed via blood sample assay | at Baseline, and at 3 months |
| Flow Mediated Diameter Percentage (FMD%) | FMD% will be assessed using brachial artery ultrasound | at Baseline and at Month 3 |
Three (3) subjects will be treated with a single IV administration of 2 x 10^7 (20 million) BMMSCs delivered via peripheral intravenous infusion. BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs) |
| BG002 | Pilot Phase: Group 3 (UCMSCs - 100 Million) | Three (3) subjects will be treated with a single IV administration of 1 x 10^8 (100 million) UCMSCs delivered via peripheral intravenous infusion. UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs) |
| BG003 | Pilot Phase: Group 4 (BMMSCs -100 Million) | Three (3) subjects will be treated with a single IV administration of 1 x 10^8 (100 million) BMMSCs delivered via peripheral intravenous infusion. BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs) |
| BG004 | Group A (UCMSCs - 100 Million) | Participants randomized to receive a single administration of 1 x 10^8 (100 million) UCMSCs delivered via peripheral intravenous infusion. UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs) |
| BG005 | Group B (BMMSCs - 100 Million) | Participants randomized to receive a single administration of 1 x 10^8 (100 million) BMMSC delivered via peripheral intravenous infusion. BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs) |
| BG006 | Group C (Placebo) | Participants randomized to receive a single administration of placebo via peripheral intravenous infusion. Placebo: a single administration of placebo delivered via peripheral intravenous infusion. |
| BG007 | Total | Total of all reporting groups |
| 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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| Pilot Phase: Group 2 (BMMSCs - 20 Million) |
Three (3) subjects will be treated with a single IV administration of 2 x 10^7 (20 million) BMMSCs delivered via peripheral intravenous infusion. BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs) |
| OG002 | Pilot Phase: Group 3 (UCMSCs - 100 Million) | Three (3) subjects will be treated with a single IV administration of 1 x 10^8 (100 million) UCMSCs delivered via peripheral intravenous infusion. UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs) |
| OG003 | Pilot Phase: Group 4 (BMMSCs -100 Million) | Three (3) subjects will be treated with a single IV administration of 1 x 10^8 (100 million) BMMSCs delivered via peripheral intravenous infusion. BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs) |
| OG004 | Group A (UCMSCs - 100 Million) | Participants randomized to receive a single administration of 1 x 10^8 (100 million) UCMSCs delivered via peripheral intravenous infusion. UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs) |
| OG005 | Group B (BMMSCs - 100 Million) | Participants randomized to receive a single administration of 1 x 10^8 (100 million) BMMSC delivered via peripheral intravenous infusion. BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs) |
| OG006 | Group C (Placebo) | Participants randomized to receive a single administration of placebo via peripheral intravenous infusion. Placebo: a single administration of placebo delivered via peripheral intravenous infusion. |
|
|
| Secondary | Cytokine Levels | Cytokine levels including the following panel of inflammatory and angiogenic markers: Interleukin-1 (IL-1), Interleukin-6 (IL-6), Tumor Necrosis Factor alpha (TNFα), and Vascular Endothelial Growth Factor (VEGF), & Stromal Cell Derived Factor (SDF-1a) levels from serum/plasma samples all measured in pg/mL. | Some participants did not complete all of the study visits per protocol due to COVID-19 pandemic restrictions. Therefore not all data is available for all time-points for all participants. Blood samples were collected for IL-1 and SDF-1a analysis, however due to cost and logistical reasons the samples were not analyzed. VEGF were to be analyzed internally using frozen plasma aliquots. No plasma samples were retained for internal testing at week 2, month 1, and month 6 in all participants. | Posted | Mean | Standard Deviation | pg/mL | at Baseline, at Week 2, at Month 1, at Month 3, and at Month 6 |
|
|
|
| Secondary | hsCRP Levels | values at baseline and follow up for the following inflammatory marker: Serum High sensitivity C-Reactive Protein (hsCRP) in mg/L. | No subjects had been randomized to Group A or C at the time of trial termination. Some participants did not complete all of the study visits per protocol. | Posted | Mean | Standard Deviation | mg/L | at Baseline, at Week 2, at Month 1, at Month 3, and at Month 6 |
|
|
|
| Secondary | Stem Cell Factor (SCF) Levels | SCF levels from serum/plasma samples measured in units of mg/mL | Blood samples were collected for SCF analysis, however due to cost and logistical reasons the samples were not analyzed and hence no data were generated. | Posted | at Baseline, at Week 2, at Month 1, at Month 3, and at Month 6 |
|
|
| Secondary | Endothelial Progenitor Cell-Colony Forming Units (EPC-CFUs) | Endothelial function will be reported as the change in Endothelial Progenitor Cell Colony Forming Unit (EPC-CFU) assessed via blood sample assay | No subjects had been randomized to Group A or C at the time of trial termination. Some participants did not complete all of the study visits per protocol. | Posted | Mean | Standard Deviation | Colony Forming Units per Well | at Baseline, and at 3 months |
|
|
|
| Secondary | Flow Mediated Diameter Percentage (FMD%) | FMD% will be assessed using brachial artery ultrasound | No subjects had been randomized to Group A or C at the time of trial termination. Some participants did not complete all of the study visits per protocol. | Posted | Mean | Standard Deviation | percentage of change in brachial artery | at Baseline and at Month 3 |
|
|
|
| 0 |
| 3 |
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | Pilot Phase: Group 2 (BMMSCs - 20 Million) | Three (3) subjects will be treated with a single IV administration of 2 x 10^7 (20 million) BMMSCs delivered via peripheral intravenous infusion. BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs) | 0 | 3 | 0 | 3 | 2 | 3 |
| EG002 | Pilot Phase: Group 3 (UCMSCs - 100 Million) | Three (3) subjects will be treated with a single IV administration of 1 x 10^8 (100 million) UCMSCs delivered via peripheral intravenous infusion. UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs) | 0 | 3 | 0 | 3 | 2 | 3 |
| EG003 | Pilot Phase: Group 4 (BMMSCs -100 Million) | Three (3) subjects will be treated with a single IV administration of 1 x 10^8 (100 million) BMMSCs delivered via peripheral intravenous infusion. BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs) | 0 | 3 | 0 | 3 | 3 | 3 |
| EG004 | Group A (UCMSCs - 100 Million) | Participants randomized to receive a single administration of 1 x 10^8 (100 million) UCMSCs delivered via peripheral intravenous infusion. UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs) | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | Group B (BMMSCs - 100 Million) | Participants randomized to receive a single administration of 1 x 10^8 (100 million) BMMSC delivered via peripheral intravenous infusion. BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs) | 0 | 2 | 0 | 2 | 1 | 2 |
| EG006 | Group C (Placebo) | Participants randomized to receive a single administration of placebo via peripheral intravenous infusion. Placebo: a single administration of placebo delivered via peripheral intravenous infusion. | 0 | 0 | 0 | 0 | 0 | 0 |
| Sepsis | Infections and infestations | Systematic Assessment |
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| Monoclonal Gammopathy of Uncertain Significance | Blood and lymphatic system disorders | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Congestive Heart Falure | Cardiac disorders | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Periorbital Hematoma | Eye disorders | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | Systematic Assessment |
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| Diabetes Mellitus Type 2 | Endocrine disorders | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Upper Respiratory Infection | Infections and infestations | Systematic Assessment |
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| Lower Respiratory Infection | Infections and infestations | Systematic Assessment |
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| Ecchymosis | Injury, poisoning and procedural complications | Systematic Assessment |
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| Injured Ankle | Injury, poisoning and procedural complications | Systematic Assessment |
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| Toenail Avulsion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Toe Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hypernatremia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypercalcemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypertriglyceridemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Creatinine Elevation | Investigations | Systematic Assessment |
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| Liver Enzyme Elevation | Investigations | Systematic Assessment |
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| Weight Gain | Investigations | Systematic Assessment |
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| Left Foot Osteomyelitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Lump on Elbow | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| RIght Leg Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Low Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Rupture of Left Distal Biceps Tendon | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Vocal Cord Paralysis | Nervous system disorders | Systematic Assessment |
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| Vasovagal Syncope | Nervous system disorders | Systematic Assessment |
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| Migrane Exacerbation | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Microhematuria | Renal and urinary disorders | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | Systematic Assessment |
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| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
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| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Diabetic Left Foot Ulcers | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Scalp Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Peripheral Vascular Disease | Vascular disorders | Systematic Assessment |
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| Pseudoaneurysm of Right Femoral Artery | Vascular disorders | Systematic Assessment |
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| Elevated Blood Pressure | Vascular disorders | Systematic Assessment |
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| Left Arm Hematoma | Vascular disorders | Systematic Assessment |
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| D009750 |
| Nutritional and Metabolic Diseases |
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| IL-6 Week 2 |
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| IL-6 Month 1 |
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| IL-6 Month 3 |
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| IL-6 Month 6 |
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| TNFa Baseline |
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| TNFa Week 2 |
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| TNFa Month 1 |
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| TNFa Month 3 |
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| TNFa Month 6 |
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| VEGF Baseline |
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| VEGF Month 3 |
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| Week 2 |
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| Month 1 |
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| Month 3 |
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| Month 6 |
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| Month 3 |
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| Month 3 |
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