Clinical trial NCT04327635: Safety Evaluation of Intracoronary Infusion of Extracellular Vesicles in Patients Following Coronary Stent Implantation
Official title: Safety Evaluation of Intracoronary Infusion of Extracellular Vesicles in Patients Following Coronary Stent Implantation (EV-CSI)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Percutaneous Coronary Intervention
Keywords: Coronary Stent Placement
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Rion LLC
First posted: 2020-03-31
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Patients who undergo Percutaneous Coronary Intervention (PCI) will be treated with a single dose of PEP within 20 minutes after stent placement or post-dilation (whichever is last). Subjects will be screened at the time of emergency room presentation. Subjects will be treated in the cardiac catheterization laboratory where the PCI will be completed and PEP will be administered. Subjects will be followed for one year after PEP administration through clinic visits.

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: Days 1-14 of the study period for each study participant.
Secondary outcomes:
measure: Infarction scar size
timeFrame: Day 7 and Day 40 of the study period for each study participant.
measure: Ejection fraction
timeFrame: Day 7 and Day 40 of the study period for each study participant.
measure: Alloimmune Response
timeFrame: Day 1 (Baseline/Screening) visit, Day 40 and Day 365
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Guy S Reeder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kisby CK, Shadrin IY, Peng LT, Stalboerger PG, Trabuco EC, Behfar A, Occhino JA. Impact of Repeat Dosing and Mesh Exposure Chronicity on Exosome-Induced Vaginal Tissue Regeneration in a Porcine Mesh Exposure Model. Female Pelvic Med Reconstr Surg. 2021 Mar 1;27(3):195-201. doi: 10.1097/SPV.0000000000001017.