Safety Evaluation of Intracoronary Infusion of Extracellular Vesicles in Patients With AMI

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Determine the safety of up to 3 dose levels of a study drug called PEP in patients who have had a recent (within the last 12 hours) heart attack.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Christopher J. McLeod; Paul G. Stalboerger
• Collaborator: Rion LLC

Criteria

Inclusion Criteria:

• Ages 21-85

• Males and females

• Acute myocardial infarction (ST elevation at the J point in at least 2 contiguous leads of

≥2 mm (0.2 mV) in men or ≥1.5 mm (0.15 mV) in women in leads V2-V3 and/or of ≥1 mm (0.1 mV) in other contiguous chest leads or the limb leads)

• Successful stent implantation within 4 and 12 hours from onset of AMI symptoms

• Angiographic evidence of TIMI 0 or TIMI 1 flow through culprit lesion prior to stent placement

• Angiographic evidence of residual stenosis visually <30% after stent placement

• Willing and able to provide signed informed consent

Exclusion Criteria:

• Prior cardiovascular history of systolic or diastolic dysfunction or acute myocardial infarction

• Received fibrinolytic therapy (i.e. tPA (tissue plasminogen activator)), prior to PCI

• Known history of stroke or TIA within the past 6 months

• 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

• 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 PCR nasal swab test