Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects With Symptomatic Ischemic Heart Disease. (ACESO-IHD) (ACESO-IHD)
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|ClinicalTrials.gov Identifier: NCT04776239|
Recruitment Status : Recruiting
First Posted : March 1, 2021
Last Update Posted : July 11, 2022
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Ischemic Heart Disease||Drug: 100 million Allogeneic Mesenchymal Human Stem Cells Other: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects With Symptomatic Ischemic Heart Disease.|
|Actual Study Start Date :||August 16, 2021|
|Estimated Primary Completion Date :||July 16, 2024|
|Estimated Study Completion Date :||July 16, 2024|
Experimental: Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).
Drug: 100 million Allogeneic Mesenchymal Human Stem Cells
1 single intravenous infusion
Experimental: Group 2: Placebo Group
Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.
Placebo delivered via peripheral intravenous infusion
- Post-Percutaneous Coronary Intervention (PCI) coronary artery endothelial function as assessed via CFR [ Time Frame: 6 months (post-infusion) ]Coronary Flow Reserve (CFR) as measured via cardiac catheterization angiography
- Post-PCI coronary artery endothelial function as assessed via FFR [ Time Frame: 6 months (post infusion) ]Fractional Flow Reserve (FFR) as measured via cardiac catheterization angiography
- Target lesion lumen loss [ Time Frame: 6 months (post-infusion) ]Target lesion lumen loss as assessed by quantitative coronary angiography (QCA).
- Flow Mediated Diameter Percentage (FMD%) [ Time Frame: 6 months post-infusion ]FMD% is measured via brachial artery ultrasound
- EPC-CFUs levels [ Time Frame: 6 months post-infusion ]Endothelial progenitor cells (EPC)-colony forming units (CFUs) will be assessed from blood samples.
- Circulating angiogenic factors marker levels [ Time Frame: 6 months post-infusion ]Circulating angiogenic marker levels including Protein Kinase B, Stromal Cell Derived Factor 1 (SDF-1), Notch, Vascular Endothelial Growth Factor (VEGF) and Colony Forming Units (CFU) will be assessed from blood samples.
- Circulating inflammatory markers [ Time Frame: 6 months post-infusion ]Circulating inflammatory markers including Cluster of Differentiation (CD) 3 CD 25 or CD 3 CD 69 will be assessed from blood samples.
- Seattle Angina Questionnaire (SAQ) Angina Frequency [ Time Frame: 6 months post-infusion ]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.
- EuroQol(EQ)-5 Dimension (5D) Quality of Life Questionnaire [ Time Frame: 6 months post-infusion ]EQ-5D Quality of Life Questionnaire has a total score ranging from 0-10 with higher scores indicating better quality of life.
- EQ-5D Quality of life Questionnaire Overall Health Status Question [ Time Frame: 6 months post-infusion ]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.
- Short Form (SF) 36 Questionnaire Quality of Life Questionnaire [ Time Frame: 6 months post-infusion ]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 0-100 scale. Lower scores indicate the more disability, and higher scores indicate less disability.
- International Index of Erectile Function (IIEF) Questionnaire [ Time Frame: 6 months post-infusion ]IIEF is a 15 item questionnaire to be completed by males only, with scores ranging from 0-75. Higher scores indicate better male sexual function/quality of life.
- Sexual Quality of Life - Females (SQOL-F) Questionnaire [ Time Frame: 6 months post-infusion ]SQOL-F Questionnaire is an 18 item questionnaire in which female participants are asked to record responses on a 6-point Likert scale (completely agree to completely disagree). Total score can range from 18 to 108. Higher scores indicate better female sexual quality of life.
- Incidence of Treatment-Emergent Serious Adverse Events (TE-SAE) [ Time Frame: 1 month post infusion ]TE-SAEs will be defined as the composite of: death, non-fatal myocardial infarction (MI), stroke, hospitalization for heart failure, sustained ventricular arrhythmias or atrial fibrillation. TE-SAEs will be assessed by treating physician.
- Incidence of Major Adverse Cardiac Events (MACE) [ Time Frame: 12 months ]Defined as the composite incidence of (1) death, (2) hospitalization for cardiovascular events or (3) non-fatal MI. MACE will be assessed by treating physician.
- Rates of Adverse Events [ Time Frame: 12 months ]Rates of treatment emergent adverse event (AE) and serious adverse event (SAE) as assessed by treating physician will be reported.
- Number of participants with abnormal lab values [ Time Frame: 12 months ]Number of participants with clinically significant abnormal serum hematology and clinical chemistry values will be reported. Clinical significance will be assessed by treating physician.
- Number of participants with Target Vessel Failure [ Time Frame: 12 months ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04776239
|Contact: Mauricio G Cohen, MDfirstname.lastname@example.org|
|Contact: Yvenie Desire, BAemail@example.com|
|Principal Investigator:||Mauricio G Cohen, MD||University of Miami|