| ID | Type | Description | Link |
|---|---|---|---|
| 1510579216 | Other Identifier | IU IRB |
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Early Termination as required by VA DSMB due to slow enrollment
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This project is to determine the safety and explore the effectiveness of allogeneic (not cells of the participant but those of another human) mesenchymal stromal cells (MSCs) in decreasing inflammation and possible enlargement of the participants' abdominal aortic aneurysm. Participants will be selected as a possible subject because of an abdominal aortic aneurysm discovered on the ultrasound or computed tomographic ("CT") scan requested by the participants' doctor.
The purpose of this study is to collect information that will be used to determine if MSCs can be used to decrease inflammation and possibly slow down enlargement of the participants' aneurysm. The investigators will also be collecting blood samples to study special inflammatory cells that cause aneurysms as well as asking participants to have a "PET" (positron emission tomography) scan that can measure inflammation directly in the participants' aneurysm.
This is a phase I, double blinded trial that will enroll 50 patients with Abdominal Aortic Aneurysms (AAA) measuring 3-5 cm in maximal transverse diameter (MTD). This study will assess the safety of MSCs in doses of 1 million MSCs/kg. or 3 million MSCs/kg. delivered intra-venously. This trial test the hypothesis that MSCs, in a dose dependent fashion, promote the frequency and immune suppressor function of CD4+CD25+ FoxP3+ T-regulatory cells and decrease AAA inflammation as measured by 18-fluorodeoxyglucose positron emission tomography/computed tomography (PET/CT). The primary safety endpoints will be incidence of treatment related adverse events accrued over 24 months. Efficacy measures are changes in frequency and immune suppressor function of Tregs, number and cytotoxic activity of CD4+/CD8+ CD28- T-cells, activated monocytes, and changes in aortic inflammation as measured by uptake of 18-FDG PET/CT compared to baseline. Incidence of surgical intervention, aneurysm related death, quality of life, and major adverse cardiac events will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous infusion of 1 million allogenic MSCs/kg | Active Comparator | In a randomized fashion, the MSCs, in the appropriate dose, will be shipped to the performance site where the MSCs will be thawed, diluted and administered. The thawed MSCs with be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry. Patients will be premedicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. Subjects will be discharged 2 hours post-infusion if no signs of complications. |
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| Intravenous infusion of 3 million allogeneic MSCs/kg | Active Comparator | In a randomized fashion, the MSCs, in the appropriate dose, will be shipped to the performance site where the MSCs will be thawed, diluted and administered.The thawed MSCs with be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry. Patients will be premedicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. Subjects will be discharged 2 hours post-infusion if no signs of complications. |
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| Intravenous infusion of Plasmalyte A (placebo) | Placebo Comparator | In a randomized fashion, the Plasmalyte A will be shipped to the performance site where it will be thawed and administered. The Plasmalyte A will be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry as will be performed on active groups in order to protect the blinding of this study. Patients will be pre-medicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. Subjects will be discharged 2 hours post-infusion if no signs of complications. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 million MSCs/kg | Biological | Intravenous infusion of 1 million allogeneic MSCs/kg. |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in Circulating Inflammatory Cell Phenotypes as Measured by Mass Cytometry | This trial will test the hypothesis that MSCs, in a dose dependent fashion (1 x 10^6 MSC/kg vs 3 x 10^6 MSC/kg) promote the frequency and immune suppressor function of Treg cells as measured by mass cytometry compared to baseline. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Related Adverse Events at 12 Months Post MSC Administration as Evidenced by the Investigator | The safety of systemic administration of allogeneic MSCs will be measured by treatment-related adverse events over a period of 12 months. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Inflammatory AAA defined by a thickened aortic wall and retroperitoneal fibrosis and adhesions of peritoneal organs, and elevated erythrocyte sedimentation rate or in the opinion of investigator.
Mycotic AAA defined as saccular morphology, a positive blood culture, fever, or in the opinion of the investigator.
Symptomatic, Saccular, or any AAA associated with thoracic aorta dilatation >5.0 cm.
Infra-renal AAA associated with Marfan's or Ehlers-Danlos Syndrome or other connective tissue disorders.
Common or external iliac artery aneurysm > 30 cm. in maximal transverse diameter.
AAA due to dissection.
Allergy to iodine contrast.
History of cancer within the last 5 years, except basal cell skin carcinoma with clean border pathology report.
Estimated glomerular filtration rate (eGFR) < 30mL/min.
Any condition requiring immunosuppressant medications (e.g., for treatment of organ transplants, psoriasis, Crohn's disease, alopecia areata, rheumatoid arthritis, scleroderma, lupus).
Acute coronary syndrome (ACS) in the last 30 days prior to enrollment.*
Congestive heart failure (CHF) hospitalization within the last 30 days prior to enrollment.*
HIV or Hepatitis C (HCV) positive.
Contraindication to Computed Tomography or known allergy to contrast media.
Any bleeding diathesis defined as an International Normalized Ratio (INR) 2.0 (off anticoagulation therapy) or history of platelet count less than 70,000 or hemophilia.
Pregnant or breast-feeding women.
Significant hepatic dysfunction (alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than 2 times normal).
Life expectancy less than two years.
Inability to provide written informed consent due to cognitive or language barriers (interpreter permitted).
Presence of any clinical condition that in the opinion of the PI or the sponsor makes the patient not suitable to participate in the trial.
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| Name | Affiliation | Role |
|---|---|---|
| Michael P Murphy, MD BS | Richard L. Roudebush VA Medical Center, Indianapolis, IN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richard L. Roudebush VA Medical Center, Indianapolis, IN | Indianapolis | Indiana | 46202-2884 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous Infusion of 1 Million Allogenic MSCs/kg | In a randomized fashion, the MSCs, in the appropriate dose, will be shipped to the performance site where the MSCs will be thawed, diluted and administered. The thawed MSCs with be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry. Patients will be premedicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo) |
| 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 | Jul 15, 2021 |
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| 3 million MSCs/kg | Biological | Intravenous infusion of 3 million allogeneic MSCs/kg |
|
| Placebo | Drug | Intravenous infusion of Plasmalyte A (placebo) |
|
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| FG001 | Intravenous Infusion of 3 Million Allogeneic MSCs/kg | In a randomized fashion, the MSCs, in the appropriate dose, will be shipped to the performance site where the MSCs will be thawed, diluted and administered.The thawed MSCs with be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry. Patients will be premedicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo) |
| FG002 | Intravenous Infusion of Plasmalyte A (Placebo) | In a randomized fashion, the Plasmalyte A will be shipped to the performance site where it will be thawed and administered. The Plasmalyte A will be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry as will be performed on active groups in order to protect the blinding of this study. Patients will be pre-medicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous Infusion of 1 Million Allogenic MSC's/Kg | In a randomized fashion, the MSCs, in the appropriate dose, will be shipped to the performance site where the MSCs will be thawed, diluted and administered. The thawed MSCs with be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry. Patients will be premedicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo) |
| BG001 | Intravenous Infusion of 3 Million Allogeneic MSCs/kg | In a randomized fashion, the MSCs, in the appropriate dose, will be shipped to the performance site where the MSCs will be thawed, diluted and administered.The thawed MSCs with be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry. Patients will be premedicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo) |
| BG002 | Intravenous Infusion of Plasmalyte A (Placebo) | In a randomized fashion, the Plasmalyte A will be shipped to the performance site where it will be thawed and administered. The Plasmalyte A will be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry as will be performed on active groups in order to protect the blinding of this study. Patients will be pre-medicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo) |
| BG003 | 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| AAA size 3.0 - 3.9 cm (max. transverse diameter) | Count of Participants | Participants |
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| AAA size 4.0 - 5.0 cm (max. transverse diameter) | 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 | Changes in Circulating Inflammatory Cell Phenotypes as Measured by Mass Cytometry | This trial will test the hypothesis that MSCs, in a dose dependent fashion (1 x 10^6 MSC/kg vs 3 x 10^6 MSC/kg) promote the frequency and immune suppressor function of Treg cells as measured by mass cytometry compared to baseline. | Posted | Mean | Standard Deviation | cells | 12 months |
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| Secondary | Incidence of Treatment Related Adverse Events at 12 Months Post MSC Administration as Evidenced by the Investigator | The safety of systemic administration of allogeneic MSCs will be measured by treatment-related adverse events over a period of 12 months. | Posted | Count of Participants | Participants | 12 months |
|
12 months
All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.
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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 | Intravenous Infusion of 1 Million Allogenic MSCs/kg | In a randomized fashion, the MSCs, in the appropriate dose, will be shipped to the performance site where the MSCs will be thawed, diluted and administered. The thawed MSCs with be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry. Patients will be premedicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo) | 0 | 6 | 0 | 6 | 3 | 6 |
| EG001 | Intravenous Infusion of 3 Million Allogeneic MSCs/kg | In a randomized fashion, the MSCs, in the appropriate dose, will be shipped to the performance site where the MSCs will be thawed, diluted and administered.The thawed MSCs with be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry. Patients will be premedicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo) | 1 | 10 | 2 | 10 | 2 | 10 |
| EG002 | Intravenous Infusion of Plasmalyte A (Placebo) | In a randomized fashion, the Plasmalyte A will be shipped to the performance site where it will be thawed and administered. The Plasmalyte A will be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry as will be performed on active groups in order to protect the blinding of this study. Patients will be pre-medicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo) | 1 | 12 | 1 | 12 | 3 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unanticipated Adverse Device Event | Product Issues | CTCAE 4.0 | Systematic Assessment | Study product sterility culture, pre-administration, was positive on Day 7. No adverse effects experienced by subject. |
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| Prostatectomy | Surgical and medical procedures | CTCAE 4.0 | Systematic Assessment |
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| Pancreatitis, acute, recurrent | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Prostate cancer | Reproductive system and breast disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Critical Limb Threatening Ischemia | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Nausea/vomiting | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hematochezia | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Weight loss | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Weight gain | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | CTCAE 4.0 | Systematic Assessment |
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| Acute hypoxic respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | CTCAE 4.0 | Systematic Assessment |
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| Atrial fibrillation, new | Cardiac disorders | CTCAE 4.0 | Systematic Assessment |
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| Chest pain | Cardiac disorders | CTCAE 4.0 | Systematic Assessment |
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| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Fluid volume overload | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Congestive Heart Failure exacerbation | Cardiac disorders | CTCAE 4.0 | Systematic Assessment |
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| Anemia, recurrent | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
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| Pain, epigastric | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Otitis externa, severe | Ear and labyrinth disorders | CTCAE 4.0 | Systematic Assessment |
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| Failure to thrive | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Fatigue, worsening | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Dehydration | General disorders | CTCAE 4.0 | Systematic Assessment |
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| Neck edema, significant | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Cardiopulmonary arrest | Cardiac disorders | CTCAE 4.0 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment | Colitis with crypt micro-abscesses |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Urinary Tract Infection | Renal and urinary disorders | CTCAE 4.0 | Systematic Assessment |
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| Pancreatitis, acute, recurrent | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Pain, abdominal | General disorders | CTCAE 4.0 | Systematic Assessment |
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| Pain, back | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Pain, knee | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Lung nodule, new | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE 4.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Colon Polyp Removal | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE 4.0 | Systematic Assessment |
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The major limitation of this trial is that it did not complete enrollment of the planned 36 subjects. This is because the trial was put on hold during the COVID pandemic and when the Richard Roudebush VAMV opened for elective procedures the VA Merit grant had expired.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael P. Murphy, MD | Roudebush VA Medical Center | 317-988-4049 | mipmurph@iupui.edu |
| Nov 10, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 15, 2021 | Aug 15, 2022 | ICF_001.pdf |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D000783 | Aneurysm |
| D001014 | Aortic Aneurysm |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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| ID | Term |
|---|---|
| C048013 | Plasmalyte A |
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| Between 18 and 65 years |
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| >=65 years |
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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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| Superiority |
These power estimates are based on linear regression of regulatory T-cell counts at each time point. These data will be summarized with the mean, median, standard deviation, standard error, minimum and maximum. |
| OG002 | Intravenous Infusion of Plasmalyte A (Placebo) | In a randomized fashion, the Plasmalyte A will be shipped to the performance site where it will be thawed and administered. The Plasmalyte A will be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry as will be performed on active groups in order to protect the blinding of this study. Patients will be pre-medicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo) |
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