Percutaneous Coronary InterventionPhase 1NCT04327635
Safety Evaluation of Intracoronary Infusion of Extracellular Vesicles in Patients Following Coronary Stent Implantation
A Phase 1 study testing PEP in people with Percutaneous Coronary Intervention, run by Christopher J. McLeod at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Percutaneous Coronary Intervention
- What is being tested?
- PEP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2021to 22 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety Evaluation of Intracoronary Infusion of Extracellular Vesicles in Patients Following Coronary Stent Implantation (EV-CSI)
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.
Read the 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.
- Conditions
- Percutaneous Coronary Intervention
- Being tested
- PEP
- Keywords
- Coronary Stent Placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEPDrug
A biological drug made of certain parts of blood from living blood donors obtained from a certified blood bank. At the time of cardiac catheterization patients will undergo one-time intracoronary infusion of 10 milliliters of PEP dosage consisting of approximately 5%, 10%, or 20% PEP. PEP dose will be infused immediately distal to the newly placed stent over approximately 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| PEP in Coronary Stent Implantation | Experimental | Patients undergoing a percutaneous coronary intervention (PCI) and possible stent placement procedure will receive a one-time intracoronary infusion of PEP within 20 minutes after stent placement or post-dilation (whichever comes last). Receives: Drug: PEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
DLTs are defined as: signs of infection present in the judgement of a reviewing MD, CTCAE Grade 2 or higher bronchial stricture (rhonchi/wheezing), or CTCAE Grade 3 or higher defined as new or reoccurring angina or anginal equivalent after infusion with PEP; elevated ALT, AST, total or direct bilirubin, unless due to procedural complications or complications of ischemic cardiomyopathy (ICM); decreased hemoglobin or platelet level, unless due to procedural complications or complications of ICM; sustained ventricular arrhythmia during PEP infusion; hypersensitivity or anaphylaxis during PEP infusion; any other grade 3 or higher adverse event.
Measured: Days 1-14 of the study period for each study participant.
Secondary outcomes (3)
Infarction scar size
Cardiac MRI will be used to assess myocardial infarction scar size.
Measured: Day 7 and Day 40 of the study period for each study participant.
Ejection fraction
Cardiac MRI will be used to assess ejection fraction.
Measured: Day 7 and Day 40 of the study period for each study participant.
Alloimmune Response
Class I \& II Antibody Single Antigen Bead testing will be completed. Changes will be documented and evaluated.
Measured: Day 1 (Baseline/Screening) visit, Day 40 and Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start2 Nov 2021
- Primary completion22 Oct 2025
- Study completion22 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher J. McLeod
- Sponsor type
- University, hospital or other
- Collaborators
- Rion LLC
- Responsible party
- Sponsor-investigator, Christopher J. McLeod, Mayo Clinic
- Investigators
- Guy S Reeder, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327635
- Sponsor's protocol ID
- 18-011636
- Status last verified
- Nov 2025
- First submitted
- 25 Mar 2020
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD, related data dictionaries, and all IPD that underlie results in a publication available.
Publications
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.
PubMed 33620904
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Evaluation of Intracoronary Infusion of Extracellular Vesicles in Patients Following Coronary Stent Implantation (EV-CSI)
- ClinicalTrials.gov ID
- NCT04327635
- Acronym / sponsor ID
- 18-011636
- Conditions
- Percutaneous Coronary Intervention
- Keywords
- Coronary Stent Placement
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Christopher J. McLeodUniversity, hospital or other
- Collaborators
- Rion LLC
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 22 Oct 2025 (actual)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEP in Coronary Stent Implantation | Experimental | Drug: PEPPatients undergoing a percutaneous coronary intervention (PCI) and possible stent placement procedure will receive a one-time intracoronary infusion of PEP within 20 minutes after stent placement or post-dilation (whichever comes last). |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEPA biological drug made of certain parts of blood from living blood donors obtained from a certified blood bank. At the time of cardiac catheterization patients will undergo one-time intracoronary infusion of 10 milliliters of PEP dosage consisting of approximately 5%, 10%, or 20% PEP. PEP dose will be infused immediately distal to the newly placed stent over approximately 5 minutes. | Drug | PEP in Coronary Stent Implantation |
Primary outcome
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).
Time frame: Days 1-14 of the study period for each study participant.
DLTs are defined as: signs of infection present in the judgement of a reviewing MD, CTCAE Grade 2 or higher bronchial stricture (rhonchi/wheezing), or CTCAE Grade 3 or higher defined as new or reoccurring angina or anginal equivalent after infusion with PEP; elevated ALT, AST, total or direct bilirubin, unless due to procedural complications or complications of ischemic cardiomyopathy (ICM); decreased hemoglobin or platelet level, unless due to procedural complications or complications of ICM; sustained ventricular arrhythmia during PEP infusion; hypersensitivity or anaphylaxis during PEP infusion; any other grade 3 or higher adverse event.
3 secondary outcomes
Infarction scar size
Time frame: Day 7 and Day 40 of the study period for each study participant.
Ejection fraction
Time frame: Day 7 and Day 40 of the study period for each study participant.
Alloimmune Response
Time frame: Day 1 (Baseline/Screening) visit, Day 40 and Day 365
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Derived from this study: PubMed 33620904Kisby 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.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD, related data dictionaries, and all IPD that underlie results in a publication available.
Related trials for Percutaneous Coronary Intervention
Not yet recruiting
Hs-CRP-Guided Colchicine Treatment Targets in Very-High-Risk Patients With Coronary Artery Disease After PCI (TARGET-CHD)
Coronary Artery Disease, Atherosclerotic Cardiovascular Disease (ASCVD)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Not yet recruiting
ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
Coronary Artery Disease, De Novo Stenosis Lesion
Recruiting
Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions
Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors
RecruitingPhase 3
Safety and Efficacy of Very Short DAPT in Older Patients Undergoing PCI
Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy S Reeder, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PEP in people with Percutaneous Coronary Intervention, run by Christopher J. McLeod at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: Days 1-14 of the study period for each study participant.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04327635, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.