Safety and Efficacy of FAP iCDC in Acute Myocardial Infarction With Cardiogenic Shock (NCT07380659) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Safety and Efficacy of FAP iCDC in Acute Myocardial Infarction With Cardiogenic Shock
China18 participantsStarted 2026-01-20
Plain-language summary
To study the safety and efficacy of fibroblast activation protein (FAP)-targeted allogeneic immunosuppressive chimeric antigen receptor-dendritic cell (CAR-DC) in the treatment of acute myocardial infarction with cardiogenic shock and provide a new method for the treatment of acute myocardial infarction with cardiogenic shock.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Post-emergent revascularization (PCI or CABG)
. Systolic blood pressure \< 90 mmHg for \>30 minutes, or requiring catecholamine support to maintain systolic blood pressure \>90 mmHg
. Signs of impaired organ perfusion, meeting at least one of the following criteria:
. Altered mental status
. Cold, clammy skin and extremities
. Oliguria, with urine output \<30 mL/h
. Arterial lactate level \>2 mmol/L
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 1 trial focused on safety in people who've had a STEMI with cardiogenic shock — what does that mean for how much is known about whether FAP iCDC actually helps patients in my situation, versus just testing whether it's safe to give?
2Since the trial isn't recruiting yet, how long might it realistically be before it opens, and should we be making treatment decisions now rather than waiting for a study that may not be available soon?
3The main things being measured are dose-limiting toxicity and treatment-emergent adverse events — given how critical cardiogenic shock already is, what kinds of serious side effects would I need to be prepared for if I were to consider a Phase 1 cell therapy on top of that?
4Are there standard-of-care treatments for post-STEMI cardiogenic shock — like mechanical circulatory support or existing medications — that I should be pursuing first, and would enrolling in this trial affect access to those?
5What does 'FAP iCDC' actually do to the heart, and is my care team familiar enough with this type of cell therapy to help me weigh whether the experimental risk makes sense given how sick I already am?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The proportion of subjects with Dose-limiting toxicity (DLT)
Timeframe: in 14 days after injection
2
Incidence of treatment-emergent adverse events (TEAEs)
Timeframe: in 14 days after injection
Trial details
NCT IDNCT07380659
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University