Could donor blood particles protect hearts after stenting?
NCT ID NCT04327635
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early study tested whether a biologic called PEP, made from donor blood particles, is safe to infuse into heart arteries right after stent placement. Nine patients received a single dose during catheterization. The goal was to see if PEP could reduce heart damage, but the main focus was on safety and finding the right dose.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PEP (extracellular vesicles from donor blood)
- What this could lead to
- If safe, this could lead to a new way to limit heart muscle damage after stent placement.
- What could go wrong
- This is a very early Phase 1 trial with only 9 participants, so safety and effectiveness are not yet proven. There are risks of allergic reactions, infection, or heart rhythm problems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
9 people
The number who actually took part.
- Started
-
Nov 2021
- Finished
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Oct 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
21 to 85 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Mayo Clinic
Rochester, Minnesota, 55905, United States
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