Logo 1 Logo 2

Clinical Trial Details

Trial ID: L3014
Source ID: NCT04776239
Associated Drug: 100 Million Allogeneic Mesenchymal Human Stem Cells
Title: Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects With Symptomatic Ischemic Heart Disease. (ACESO-IHD)
Acronym: ACESO-IHD
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus|Ischemic Heart Disease
Interventions: DRUG: 100 million Allogeneic Mesenchymal Human Stem Cells|OTHER: Placebo
Outcome Measures: Primary: EPC-CFU levels, 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., 6 months post-infusion|Flow Mediated Diameter Percentage (FMD%), FMD% is measured via brachial artery ultrasound. The unit of measure is percent., 6 months post-infusion | Secondary: Target lesion lumen loss, Target lesion lumen loss as assessed by quantitative coronary angiography (QCA). The unit of measure is millimeters (mm)., 6 months (post-infusion)|Circulating angiogenic factors marker levels, Circulating angiogenic marker levels will be assessed from blood samples. The unit of measure is pg/mL, 6 months post-infusion|Circulating inflammatory markers, Circulating inflammatory markers including will be assessed from blood samples. The unit of measure is pg/mL., 6 months post-infusion|Seattle Angina Questionnaire (SAQ) Angina Frequency, 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., 6 months post-infusion|EuroQol 5 Dimension (EQ-5D) Quality of life Questionnaire Overall Health Status Question, EQ-5D Quality of Life Questionnaire Overall Health Status question has a total score ranging from 0-100 with higher scores indicating better quality of life. The unit of measure is score on a scale., 6 months post-infusion|Short Form (SF) 36 Questionnaire Quality of Life Questionnaire, SF 36 Quality of Life Questionnaire consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a score on an scale of 0-100. Lower scores indicate the more disability, and higher scores indicate less disability., 6 months post-infusion|Number of 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 measure is number of events., 1 month post infusion|Number of 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 measure is number of events, 12 months|Number of Treatment Emergent Adverse Events, Rates of treatment emergent adverse event (AE) as assessed by treating physician will be reported. The unit of measure is number of events., 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|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. The unit of measure is number of participants., 12 months|Post-Percutaneous Coronary Intervention (PCI) coronary artery endothelial function as assessed via CFR, Coronary Flow Reserve (CFR) as measured via cardiac catheterization angiography. The value is expressed as a ratio that is calculated by dividing the maximum coronary blood flow (mL/min/g) by the resting blood flow (mL/min/g), 6 months (post-infusion)|Post-PCI coronary artery endothelial function as assessed via FFR, Fractional Flow Reserve (FFR) as measured via cardiac catheterization angiography. FFR is a dimensionless number that ranges from 0 to 1 that is a ratio of two pressures (mmHg)., 6 months (post infusion)
Sponsor/Collaborators: Sponsor: Joshua M Hare | Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2021-08-16
Completion Date: 2025-09-30
Results First Posted:
Last Update Posted: 2025-02-24
Locations: University of Miami, Miami, Florida, 33136, United States
URL: https://clinicaltrials.gov/show/NCT04776239