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

NCT04327635 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 18-011636
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Coronary Stent Placement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Infarction scar size

  Day 7 and Day 40 of the study period for each study participant.

• Ejection fraction

  Day 7 and Day 40 of the study period for each study participant.

• Alloimmune Response

  Day 1 (Baseline/Screening) visit, Day 40 and Day 365

Study Arms (1)

PEP in Coronary Stent Implantation

EXPERIMENTAL

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

Interventions

PEP DRUG

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.

PEP in Coronary Stent Implantation

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christopher J. McLeod: lead
• Rion LLC: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Kisby CK, Shadrin IY, Peng LT, Stalboerger PG, Trabuco EC, Behfar A, Occhino JA. Impact of Repeat Dosing and Mesh Exposure Chronicity on Exosome-Induced Vaginal Tissue Regeneration in a Porcine Mesh Exposure Model. Female Pelvic Med Reconstr Surg. 2021 Mar 1;27(3):195-201. doi: 10.1097/SPV.0000000000001017.

  PMID: 33620904 DERIVED

Study Officials

• Guy S Reeder, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: March 31, 2020
• Study Start: November 2, 2021
• Primary Completion: October 22, 2025
• Study Completion: October 22, 2025
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• Access Criteria: IPD will only be shared with the collaborator, Rion, LLC.

Locations

US (1)