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Clinical Trial Details

Trial ID: L5195
Source ID: NCT02886884
Associated Drug: 20 Million Allogeneic Mesenchymal Human Stem Cells
Title: Allogeneic Mesenchymal Human Stem Cells Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects
Acronym: ACESO
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02886884/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: 20 million Allogeneic Mesenchymal Human Stem Cells|DRUG: 100 million Allogeneic Mesenchymal Human Stem Cells
Outcome Measures: 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., Up to one month (post infusion) | Secondary: 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, 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
Sponsor/Collaborators: Sponsor: Joshua M Hare | Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 16
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2017-10-20
Completion Date: 2020-09-03
Results First Posted: 2022-05-11
Last Update Posted: 2022-05-11
Locations: University of Miami Miller School of Medicine, Miami, Florida, 33136, United States
URL: https://clinicaltrials.gov/show/NCT02886884