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Safety Evaluation of Intracoronary Infusion of Extracellular Vesicles in Patients Following Coronary Stent Implantation

NCT04327635 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-11-10

No results posted yet for this study

Summary

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.

Conditions

  • Percutaneous Coronary Intervention

Interventions

DRUG

PEP

A biological drug made of certain parts of blood from living blood donors obtained from a certified blood bank. At the time of cardiac catheterization patients will undergo one-time intracoronary infusion of 10 milliliters of PEP dosage consisting of approximately 5%, 10%, or 20% PEP. PEP dose will be infused immediately distal to the newly placed stent over approximately 5 minutes.

Sponsors & Collaborators

  • Rion LLC

    collaborator UNKNOWN

  • Christopher J. McLeod

    lead OTHER

Principal Investigators

  • Guy S Reeder, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-02
Primary Completion
2025-10-22
Completion
2025-10-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04327635 on ClinicalTrials.gov