drugset / Trial / NCT04327635

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

NCT04327635 ↗

Phase 1 Completed 9 enrolled Christopher J. McLeod Rion LLC · collab
NaSequentialOpen-labelTreatment

Summary

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.

Timeline

Start
2021-11-02
Primary completion
2025-10-22
Completion
2025-10-22

Drugs

EvaluationDrugModalityDoseRoute
Subject PEP Other / unclassified 5 % Other
Subject PEP Other / unclassified 10 ml Other
Subject PEP Other / unclassified 10 % Other
Subject PEP Other / unclassified 20 % Other

Indications

No indication recorded.