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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (baseline/screening) visit, day 40 and day 365
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am scheduled for or have had a coronary stent placement.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Alloimmune Response
Ejection fraction
Infarction scar size
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
Find a Location
Who is running the clinical trial?
Christopher J. McLeodLead Sponsor
Rion LLCUNKNOWN
1 Previous Clinical Trials
8 Total Patients Enrolled
Guy S Reeder, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver tests were twice as high as the normal range in the past year.I am scheduled for or have had a coronary stent placement.You have an allergy to heparin or a condition called heparin-induced thrombocytopenia.I have a history of cancer, but not non-melanoma skin cancer.I am legally blind.My kidney function is low, with creatinine >2 mg/dL or GFR ≤30 mL/min.I have chosen not to be resuscitated (DNR/DNI) before or plan to after my heart procedure.I do not speak English.I have not had major surgery or serious injury in the last 14 days.I am on medication for a long-term inflammation condition.I am unable to make decisions for myself.I am a woman able to have children and agree to use birth control for 3 months after treatment.I can visit the study site for all my follow-ups.I speak English but cannot read or write.You have received an organ transplant in the past.
Research Study Groups:
This trial has the following groups:- Group 1: PEP in Coronary Stent Implantation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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