Clinical Trials/NCT04776239

NCT04776239

Completed

Phase 1

Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects With Symptomatic Ischemic Heart Disease.

Joshua M Hare1 site in 1 country26 target enrollmentAugust 16, 2021

ConditionsDiabetes Mellitus Ischemic Heart Disease

Interventions100 million Allogeneic Mesenchymal Human Stem Cells Placebo

Overview

Phase: Phase 1
Intervention: 100 million Allogeneic Mesenchymal Human Stem Cells
Conditions: Diabetes Mellitus
Sponsor: Joshua M Hare
Enrollment: 26
Locations: 1
Primary Endpoint: EPC-CFU levels
Status: Completed
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to test the hypothesis that allogeneic Mesenchymal Stem Cells (MSCs) promote systemic and coronary endothelial repair through rescue of bone marrow progenitors in type 2 diabetic patients with symptomatic IHD compared to placebo.

Registry

clinicaltrials.gov

Start Date

August 16, 2021

End Date

August 26, 2025

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Joshua M Hare

Responsible Party

Sponsor Investigator

Principal Investigator

Joshua M Hare

Professor of Clinical Medicine

University of Miami

Eligibility Criteria

Inclusion Criteria

•Be ≥ 18 years of age (males and females).
•Provide written informed consent.
•Have a diagnosis of symptomatic ischemic heart disease (IHD) and an indication for standard-of-care coronary angiography.
•Have Diabetes Mellitus (DM) type 2 documented by glycated hemoglobin (HbA1C) \> 7%, or on medical therapy for diabetes.

Exclusion Criteria

•Be younger than 18 years of age.
•Have history of prior myocardial Infarction and revascularization.
•Have a baseline glomerular filtration rate (GFR) \<30 ml/min 1.73m2 estimated using the Modification of Diet for Renal Disease (MDRD) formula.
•Have poorly controlled blood glucose levels with hemoglobin A1C \> 8.5% in the previous 3 months.
•Have a history of proliferative retinopathy or severe neuropathy requiring medical treatment.
•Have an indication for standard-of-care surgical (including valve surgery, placement of left-ventricular assist device) or percutaneous intervention for the treatment of valvular heart disease (including valvuloplasty).
•Have known hypersensitivity or contraindication to aspirin; both heparin and bivalirudin; all available P2Y12 inhibitors (clopidogrel, prasugrel, and ticagrelor); or any zotarolimus, cobalt, chromium, nickel, tungsten, acrylic, or fluoropolymers; or hypersensitivity to contrast media that cannot be adequately premedicated.
•Have a hematologic abnormality as evidenced by hematocrit \< 25%, white blood cell \< 2,500/microliter (uL) or platelet values \< 100,000/uL without another explanation (per investigator discretion).
•Have liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the upper limit of normal.
•Have a bleeding diathesis or coagulopathy (INR \> 1.3), cannot be withdrawn from anticoagulation therapy, or will refuse blood transfusions.

Arms & Interventions

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).

Intervention: 100 million Allogeneic Mesenchymal Human Stem Cells

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.

Intervention: Placebo

Outcomes

Primary Outcomes

EPC-CFU levels

Time Frame: 6 months post-infusion

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.

Flow Mediated Diameter Percentage (FMD%)

Time Frame: 6 months post-infusion

FMD% is measured via brachial artery ultrasound. The unit of measure is percent.

Secondary Outcomes

Target lesion lumen loss(6 months (post-infusion))
Circulating angiogenic factors marker levels(6 months post-infusion)
Circulating inflammatory markers(6 months post-infusion)
Seattle Angina Questionnaire (SAQ) Angina Frequency(6 months post-infusion)
EuroQol 5 Dimension (EQ-5D) Quality of life Questionnaire Overall Health Status Question(6 months post-infusion)
Short Form (SF) 36 Questionnaire Quality of Life Questionnaire(6 months post-infusion)
Number of Treatment-Emergent Serious Adverse Events (TE-SAE)(1 month post infusion)
Number of Major Adverse Cardiac Events (MACE)(12 months)
Number of Treatment Emergent Adverse Events(12 months)
Number of participants with abnormal lab values(12 months)
Number of participants with Target Vessel Failure(12 months)
Post-Percutaneous Coronary Intervention (PCI) coronary artery endothelial function as assessed via CFR(6 months (post-infusion))
Post-PCI coronary artery endothelial function as assessed via FFR(6 months (post infusion))