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Extracellular Vesicles

PEP for Post-Stent Heart Recovery

Phase 1

Waitlist Available

Led By Guy S Reeder, MD

Research Sponsored by Christopher J. McLeod

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing ≥1 elective, urgent, or emergent coronary stent implantation

Be older than 18 years old

Must not have

Known history of malignancy of any type except non-melanoma skin cancer

Legally blind

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 (baseline/screening) visit, day 40 and day 365

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety of a new drug for people who have had a heart attack.

Who is the study for?

This trial is for people who've had a coronary stent placed and show less than 30% blockage after the procedure. Participants must be able to return for follow-ups, live within 90 miles of the study site, and give informed consent. It's not for pregnant or breastfeeding women, those with decision-making impairments, prisoners, non-English speakers, certain viral infections (like HIV), severe kidney/liver issues, low hemoglobin levels, recent drug use or major surgery/trauma.

What is being tested?

The trial tests PEP—a biological drug made from blood components—to see if it can prevent heart damage when injected into patients who have received a coronary stent. PEP is mixed with heparinized saline before being administered intracoronarily.

What are the potential side effects?

Potential side effects are not explicitly listed in the provided information but may include reactions related to immune response due to biological nature of PEP or complications associated with intracoronary infusion such as bleeding or clotting at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for or have had a coronary stent placement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of cancer, but not non-melanoma skin cancer.

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I am legally blind.

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My kidney function is low, with creatinine >2 mg/dL or GFR ≤30 mL/min.

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I have chosen not to be resuscitated (DNR/DNI) before or plan to after my heart procedure.

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I do not speak English.

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I have not had major surgery or serious injury in the last 14 days.

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I am on medication for a long-term inflammation condition.

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I am unable to make decisions for myself.

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I am a woman able to have children and agree to use birth control for 3 months after treatment.

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I speak English but cannot read or write.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (baseline/screening) visit, day 40 and day 365

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 (baseline/screening) visit, day 40 and day 365

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (baseline/screening) visit, day 40 and day 365 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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).

Secondary study objectives

Alloimmune Response

Ejection fraction

Infarction scar size

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PEP in Coronary Stent ImplantationExperimental Treatment1 Intervention

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PEP

2019

N/A

~890

0 / 11Eligibility criteria met