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Could donor blood particles protect hearts after stenting?

NCT ID NCT04327635

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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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