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Extracellular Vesicles

PEP for Post-Stent Heart Recovery

Q: Is this experimental procedure open to those of senior age?

This trial is open for patients between the ages of 21 and 85. Additionally, there are 9 studies designed specifically to help children under 18 and 324 options available for seniors above 65 years old.

Q: Has the FDA sanctioned Percutaneous Endoscopic Procedures in Acute Myocardial Infarction?

Due to the lack of clinical data supporting PEP's efficacy and safety as it relates to Acute Myocardial Infarction, our Power team gave this intervention a score of 1.

Q: How many individuals are being enrolled in this experiment?

Correct. Clinicaltrials.gov reveals that this medical investigation, initially posted on November 2nd 2021, is currently enlisting participants. Exactly 23 individuals must be recruited from 1 facility for the trial to proceed as planned.

Q: Is there still an opportunity for participants to join this research study?

Affirmative. Clinicaltrials.gov reflects that this medical trial is presently looking for volunteers, having been initially posted on November 2nd 2021 and recently updated on February 23rd 2022. The research requires 23 participants from a single site to participate in the program.

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 below

Select...

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

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

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

0 / 1Eligibility criteria met

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

PEP (Extracellular Vesicles) Clinical Trial Eligibility Overview. Trial Name: NCT04327635 — Phase 1

Percutaneous Coronary Intervention Research Study Groups: PEP in Coronary Stent Implantation

Percutaneous Coronary Intervention Clinical Trial 2023: PEP Highlights & Side Effects. Trial Name: NCT04327635 — Phase 1

PEP (Extracellular Vesicles) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04327635 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any possibility of me becoming a participant in this medical study?

"Participants for this cardiovascular study must be between 21 and 85 years old, living within 90 miles of the clinical site and have sustained a myocardial infarction. Additionally, requirements include successful stent implantation in 4 to 12 hours from diagnosis as well as angiographic evidence of TIMI 0 or TIMI 1 flow through culprit lesion prior to stenting with residual stenosis visually <30% post-stenting. Furthermore, all potential enrollees require signed informed consent before entering the trial."

Answered by AI

Is this experimental procedure open to those of senior age?

"This trial is open for patients between the ages of 21 and 85. Additionally, there are 9 studies designed specifically to help children under 18 and 324 options available for seniors above 65 years old."

Answered by AI

Has the FDA sanctioned Percutaneous Endoscopic Procedures in Acute Myocardial Infarction?

"Due to the lack of clinical data supporting PEP's efficacy and safety as it relates to Acute Myocardial Infarction, our Power team gave this intervention a score of 1."

Answered by AI

How many individuals are being enrolled in this experiment?

"Correct. Clinicaltrials.gov reveals that this medical investigation, initially posted on November 2nd 2021, is currently enlisting participants. Exactly 23 individuals must be recruited from 1 facility for the trial to proceed as planned."

Answered by AI

Is there still an opportunity for participants to join this research study?

"Affirmative. Clinicaltrials.gov reflects that this medical trial is presently looking for volunteers, having been initially posted on November 2nd 2021 and recently updated on February 23rd 2022. The research requires 23 participants from a single site to participate in the program."

Answered by AI

Recent research and studies

Female Pelvic Medicine & Reconstructive SurgeryJournal

Impact of Repeat Dosing and Mesh Exposure Chronicity on Exosome-induced Vaginal Tissue Regeneration in a Porcine Mesh Exposure Model

Kisby, Cassandra K., Ilya Y. Shadrin, Lillian T. Peng, Paul G. Stalboerger, Emanuel C. Trabuco, Atta Behfar, and John A. Occhino. 2021. “Impact of Repeat Dosing and Mesh Exposure Chronicity on Exosome-induced Vaginal Tissue Regeneration in a Porcine Mesh Exposure Model”. Female Pelvic Medicine & Reconstructive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/spv.0000000000001017.

clinicaltrials.govStudy

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

Christopher J. McLeod 2021. "Safety Evaluation of Intracoronary Infusion of Extracellular Vesicles in Patients Following Coronary Stent Implantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04327635.