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

NCT ID: NCT04327635

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-02
• Study Completion Date: 2025-10-22

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.

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.

Conditions

Percutaneous Coronary Intervention

Keywords

Coronary Stent Placement

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

PEP

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rion LLC

UNKNOWN

Sponsor Role: collaborator

Christopher J. McLeod

OTHER

Sponsor Role: lead

Responsible Party

Christopher J. McLeod

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Guy S Reeder, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33620904 (View on PubMed)

Other Identifiers

18-011636

Identifier Type: -

Identifier Source: org_study_id