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

November 7, 2025 updated by: Christopher J. McLeod

Safety Evaluation of Intracoronary Infusion of Extracellular Vesicles in Patients Following Coronary Stent Implantation (EV-CSI)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients who undergo Percutaneous Coronary Intervention (PCI) will be treated with a single dose of PEP within 20 minutes after stent placement or post-dilation (whichever is last). Subjects will be screened at the time of emergency room presentation. Subjects will be treated in the cardiac catheterization laboratory where the PCI will be completed and PEP will be administered. Subjects will be followed for one year after PEP administration through clinic visits.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PEP in Coronary Stent Implantation
Patients undergoing a percutaneous coronary intervention (PCI) and possible stent placement procedure will receive a one-time intracoronary infusion of PEP within 20 minutes after stent placement or post-dilation (whichever comes last).
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Time Frame: Days 1-14 of the study period for each study participant.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Infarction scar size
Time Frame: Day 7 and Day 40 of the study period for each study participant.
Cardiac MRI will be used to assess myocardial infarction scar size.
Day 7 and Day 40 of the study period for each study participant.
Ejection fraction
Time Frame: Day 7 and Day 40 of the study period for each study participant.
Cardiac MRI will be used to assess ejection fraction.
Day 7 and Day 40 of the study period for each study participant.
Alloimmune Response
Time Frame: Day 1 (Baseline/Screening) visit, Day 40 and Day 365
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Christopher J. McLeod

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rion LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guy S Reeder, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 22, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 22, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18-011636

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

There is a plan to make IPD, related data dictionaries, and all IPD that underlie results in a publication available.

IPD Sharing Time Frame

Prior to study initiation, the study protocol and informed consent form will be provided to Rion, LLC. During the study, all safety reports (as they happen or quarterly), and all SAEs as they happen will be reported to Rion, LLC. At the end of the study after database is locked, a formal clinical study report will be provided to Rion, LLC.

IPD Sharing Access Criteria

IPD will only be shared with the collaborator, Rion, LLC.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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