Percutaneous Coronary Intervention Clinical Trial
Official title:
Safety Evaluation of Intracoronary Infusion of Extracellular Vesicles in Patients Following Coronary Stent Implantation (EV-CSI)
Verified date | July 2023 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the safety of using a biological drug called PEP in people who have had a coronary stent placed. A biological drug is a substance that is made from a living organism or its products (parts). In this case, PEP is made of certain parts of blood from living blood donors obtained from a certified blood bank. PEP comes in a powder form and is mixed with heparinized saline (a solution used to prevent clots in catheters) to create a solution that can be injected. The investigators want to see if PEP can be used to stop or slow heart damage.
Status | Enrolling by invitation |
Enrollment | 12 |
Est. completion date | November 2025 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 85 Years |
Eligibility | Inclusion Criteria: - Undergoing =1 elective, urgent, or emergent coronary stent implantation - Angiographic evidence of TIMI 3 flow through the stented vessel after stent placement - Angiographic evidence of residual stenosis visually <30% after stent placement - Willing and able to provide signed informed consent - Lives within 90 mile radius of study site - Willing and able to return to study site for all follow-up visits Exclusion Criteria: - Prior solid organ transplantation at any time - Pregnant or lactating at screening - Known presence of chronic systemic inflammatory disorder that requires ongoing therapy with immunosuppressive agents - Known immune system compromise including but not limited to human immunodeficiency virus (HIV), hepatitis A, hepatitis B (HBV) or hepatitis C (HCV) infection - Known history of malignancy of any type except non-melanoma skin cancer - Known serum creatinine >2 mg/dL or GFR =30 mL/min within the last twelve months - Known AST, ALT, and/or bilirubin (total) elevated twice the upper limit of normal for age & gender within the last twelve months - Known Hemoglobin lower than 8.0 g/dL within the last twelve months - Known current illicit drug use at screening - Other major surgical procedure or major trauma within the previous 14 days prior to enrollment - Female of child bearing potential who is unwilling to agree to use acceptable contraception methods for 3 months after receiving the investigational drug - Pacemaker/ICD implant in place - Adult lacking decision-making capacity - Prisoner - Non-English speaking - English-speaking but illiterate - Legally blind - Known allergy to heparin or heparin-induced thrombocytopenia - Known history of positive SARS-CoV2 testing within the last 30 days - DNR/DNI status prior to PCI procedure or planned DNR/DNI status after PCI procedure - Homeless or no permanent address at the time of enrollment |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Christopher J. McLeod | Rion LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose limiting toxicities (DLTs) and maximum tolerated dose (MTD) of a single dose (10 mL) of PEP at escalating concentrations of extracellular vesicles delivered at a single time point (after PCI). | DLTs are defined as: signs of infection present in the judgement of a reviewing MD, CTCAE Grade 2 or higher bronchial stricture (rhonchi/wheezing), or CTCAE Grade 3 or higher defined as new or reoccurring angina or anginal equivalent after infusion with PEP; elevated ALT, AST, total or direct bilirubin, unless due to procedural complications or complications of ischemic cardiomyopathy (ICM); decreased hemoglobin or platelet level, unless due to procedural complications or complications of ICM; sustained ventricular arrhythmia during PEP infusion; hypersensitivity or anaphylaxis during PEP infusion; any other grade 3 or higher adverse event. | Days 1-14 of the study period for each study participant. | |
Secondary | Infarction scar size | Cardiac MRI will be used to assess myocardial infarction scar size. | Day 7 and Day 40 of the study period for each study participant. | |
Secondary | Ejection fraction | Cardiac MRI will be used to assess ejection fraction. | Day 7 and Day 40 of the study period for each study participant. | |
Secondary | Alloimmune Response | Class I & II Antibody Single Antigen Bead testing will be completed. Changes will be documented and evaluated. | Day 1 (Baseline/Screening) visit, Day 40 and Day 365 |
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