PEP for Post-Stent Heart Recovery
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are on immunosuppressive agents for a chronic inflammatory disorder, you may not be eligible to participate.
What data supports the effectiveness of the treatment PEP for post-stent heart recovery?
Is PEP for Post-Stent Heart Recovery safe for humans?
How does the PEP treatment differ from other treatments for post-stent heart recovery?
PEP treatment is unique because it involves postconditioning, a process that protects the heart by limiting damage during the initial phase of blood flow restoration after a blockage. This approach targets mitochondrial pathways to reduce heart muscle damage, which is different from standard treatments that primarily focus on restoring blood flow.1112131415
What is the purpose of this trial?
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.
Research Team
Guy S Reeder
Principal Investigator
Mayo Clinic
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a one-time intracoronary infusion of PEP within 20 minutes after stent placement or post-dilation
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of dose limiting toxicities and myocardial infarction scar size
Treatment Details
Interventions
- PEP
Find a Clinic Near You
Who Is Running the Clinical Trial?
Christopher J. McLeod
Lead Sponsor
Rion LLC
Collaborator