Cardiogenic ShockPhase 1NCT07380659
Safety and Efficacy of FAP iCDC in Acute Myocardial Infarction With Cardiogenic Shock
A Phase 1 study testing FAP allogeneic immunosuppressive CAR-DC in people with Cardiogenic Shock and Cardiogenic Shock Post Myocardial Infarction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiogenic Shock, Cardiogenic Shock Post Myocardial Infarction, STEMI - ST Elevation Myocardial Infarction
- What is being tested?
- FAP allogeneic immunosuppressive CAR-DC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2026to 28 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and < 80 years.
- Acute ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock, meeting all the following conditions:
- 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
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- Cold, clammy skin and extremities
- Oliguria, with urine output <30 mL/h
- Arterial lactate level >2 mmol/L
- The patient or their legally authorized representative is capable of providing verbal confirmation of understanding the trial risks, benefits, and treatment alternatives associated with receiving immunosuppressive CAR-DC therapy, and provides written informed consent prior to participation in this clinical trial.
- Age ≥ 18 years and ≤ 75 years.
- Has provided written informed consent.
- Hematocrit >30%, lymphocyte count >0.5 × 10^9/L, platelet count >60 × 10^9/L.
- Pathogen screening results must be negative for HIV (antigen, core antibody, and RNA), HBV (surface antigen and core antibody), HCV, syphilis, CMV, and EBV.
Who cannot join
- Acute mechanical complications of infarction (e.g., ventricular septal rupture, acute mitral regurgitation).
- Cardiac arrest.
- Hypoxic-ischemic brain injury (cerebral injury with fixed and dilated pupils not attributable to medication).
- Shock due to other causes (e.g., sepsis, hypovolemia).
- Resuscitation duration >30 minutes.
- Absence of spontaneous cardiac activity.
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- Persistent electrical instability.
- Active bleeding or contraindications to heparin use.
- Active autoimmune disease requiring immunosuppressive therapy.
- History of malignancy.
- Infection, including:
- Active hepatitis B (HBV DNA >1000 copies/mL by PCR), hepatitis C, syphilis, or HIV infection at screening.
- Uncontrolled systemic fungal, bacterial, viral, or other pathogen infections.
- Pregnant women.
- Contraindications to the investigational drug or study procedures.
- Active infection requiring treatment.
- History of malignancy.
- Active autoimmune disease requiring immunosuppressive therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Xinyang Hu, 86-0571-87783777, hxy0507@zju.edu.cn
About this study
Official title: Safety and Efficacy of Allogeneic Immunosuppressive CAR-DC Targeting FAP in the Treatment of Acute Myocardial Infarction With Cardiogenic Shock
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.
Read the detailed description
Background: Cardiogenic shock following acute myocardial infarction (AMI) remains a major unresolved clinical challenge. Despite advances in urgent revascularization and mechanical circulatory support, short-term mortality remains unacceptably high, approaching 40% within 30 days. Few evidence-based therapies have demonstrated a meaningful survival benefit, highlighting the urgent need for novel, mechanism-driven interventions. Growing clinical and experimental evidence indicates that a dysregulated systemic inflammatory response-manifested by hyperthermia, leukocytosis, and elevated proinflammatory mediators-plays a central role in the pathophysiology and progression of cardiogenic shock. Excessive inflammation exacerbates myocardial dysfunction, promotes multiorgan injury, and impairs recovery, suggesting that targeted immunomodulation may represent a complementary therapeutic strategy in this high-risk population. Dendritic cells (DCs), as professional antigen-presenting cells, occupy a pivotal position at the interface of innate and adaptive immunity and are uniquely suited to orchestrate context-dependent immune responses. In particular, tolerogenic DCs exert potent immunosuppressive effects through regulatory cytokine production, expression of co-inhibitory ligands, antigen-specific suppression of effector T cells, and induction of regulatory T cells. Collectively, these properties render DCs an attractive yet underexplored cellular platform for resolving excessive inflammation and promoting tissue repair in cardiogenic shock with AMI.
Purpose: In this prospective clinical study, the investigators engineered a stable, immunosuppressive, and fibrotic lesion-targeted DC therapy, termed immunosuppressive DCs (iCDC). This study was designed to evaluate the safety and preliminary efficacy of allogeneic fibroblast activation protein (FAP)-targeted iCDC therapy in patients with AMI complicated by cardiogenic shock.
Study design: This single-center, prospective, concurrent non-randomized controlled clinical trial enrolls patients aged 18-80 years presenting with acute myocardial infarction complicated by cardiogenic shock. Eligible patients are treated with allogeneic FAP-targeted immunosuppressive iCDC therapy.
Outcome measure: The primary outcome is the safety of FAP-targeted immunosuppressive iCDC therapy in patients with AMI complicated by cardiogenic shock. Secondary outcomes include 30-day all-cause mortality; hemodynamic parameters following iCDC therapy (systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate); time to hemodynamic stabilization; dose and duration of vasopressor and inotropic support; arterial lactate levels; changes in biomarkers (BNP, CRP, creatinine, ALT, AST, and inflammatory mediators); need for and duration of mechanical ventilation; need for and duration of left ventricular assist device implantation; intensive care unit and total hospital length of stay; left ventricular ejection fraction assessed by echocardiography; SAPS II score; SCAI shock classification; heart failure symptom burden assessed by NYHA functional class and the Kansas City Cardiomyopathy Questionnaire; incidence of major adverse cardiovascular events (MACE), including cardiac death and heart failure hospitalization; and incidence of adverse events.
- Conditions
- Cardiogenic Shock, Cardiogenic Shock Post Myocardial Infarction, STEMI - ST Elevation Myocardial Infarction
- Being tested
- FAP allogeneic immunosuppressive CAR-DC
- Keywords
- acute myocardial infarction with cardiogenic shock
- Medical subject headings
- Shock, Cardiogenic, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAP allogeneic immunosuppressive CAR-DCBiological
Each subject receive FAP immunosuppressive CAR-DC by intravenous infusion at the first day of shock.
| Study group | Role | What they receive |
|---|---|---|
| Administration of allogeneic FAP iCDC | Experimental | Administration of FAP immunosuppressive CAR-DC cell therapy in AMI CS. Patients are planned to be enrolled in the dose-escalation trial (1×10^5/kg、4×10^5/kg、and 8×10^5/kg) .The first dose group (4×10⁵/kg) initially enrolls 3 subjects to observe Dose-Limiting Toxicity (DLT) responses.
1. If no DLT occurs and all 3 subjects demonstrate efficacy after 6 months of treatment, and this dose is determined as the safe and effective dose.
2. If 1 subject experiences DLT, 3 additional subjects are enrolled. ·If 1/6 subjects develops DLT, and efficacy is not fully achieved in all 6 subjects, escalate to the next dose group (8×10^5/kg). ·If ≥2/6 subjects develop DLT, de-escalate to the previous dose group (1×10^5/kg).
3. After identifying a safe and effective dose, enrollment will be expanded at this dose to bring the total sample size to 8-10 subjects, to further evaluate safety and efficacy. Receives: Biological: FAP allogeneic immunosuppressive CAR-DC |
| Standard therapy | No intervention | Patients in the control group do not receive cellular therapy intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with Dose-limiting toxicity (DLT)
The proportion of participants with DLT as assessed by CTCAE v5.0
Measured: in 14 days after injection
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of iCDC treatment-emergent adverse events
Measured: in 14 days after injection
Secondary outcomes (29)
All-cause mortality
All-cause mortality at 30 days after iCDC treatment
Measured: 30 days after injection
Systolic blood pressure
Systolic blood pressure (mmHg) measured using a calibrated sphygmomanometer under standardized conditions.
Measured: 24 hours、48 hours、72 hours、7 days after injection
Diastolic blood pressure
Diastolic blood pressure (mmHg) measured using a calibrated sphygmomanometer under standardized conditions.
Measured: 24 hours、48 hours、72 hours、7 days after injection
Mean arterial pressure
The mean arterial pressure (MAP) is calculated using the following formula:
MAP=DBP+1/3(SBP-DBP)；DBP : Diastolic blood pressure，SBP ：Systolic blood pressure
Measured: 24 hours、48 hours、72 hours、7 days after injection
Time to hemodynamic stability
Sustained (> 60 min) systolic blood pressure >90 mmHg without requirement for catecholamines and without signs of peripheral endorgan hypoperfusion
Measured: From the end of the iCDC infusion to achievement of hemodynamic stability, assessed continuously until ICU discharge (up to 30 days).
Dose of vasopressors
Dose of vasopressors administered to the participant.
Measured: 24 hours、48 hours、72 hours、7 days after injection
Duration of vasopressor use
Duration of vasopressor therapy in days treated with vasopressor between enrollment and hospital discharge. A day treated with vasopressor is any day during the hospital period where the patient received a vasopressor.
Measured: From enrollment to hospital discharge (up to 30 days).
Dose of inotropic drugs
Dose of inotropic drugs administered to the participant.
Measured: 24 hours、48 hours、72 hours、7 days after injection
Duration of inotropic drugs use
Duration of inotropic drugs therapy in days treated with inotropic drugs between enrollment and hospital discharge. A day treated with inotropic drugs is any day during the hospital period where the patient received inotropic drugs
Measured: From enrollment to hospital discharge (up to 30 days).
Serum lactate level
Lactate is assessed via arterial blood gas analysis.
Measured: The measurement frequency is once every 8 hours for a duration of 48 hours.
Change in B-type natriuretic peptide (BNP) level from baseline
Change in serum B-type natriuretic peptide concentration compared with baseline.
Measured: 7 days，14 days，30 days after injection.
Change in C-reactive protein (CRP) level from baseline
Change in serum C-reactive protein concentration compared with baseline.
Measured: 24 hours, 72 hours, 7 days，14 days after injection.
Change in serum creatinine level from baseline
Change in serum creatinine concentration compared with baseline.
Measured: 24 hours, 72 hours, 7 days，14 days after injection.
Change in ALT (Alanine Aminotransferase) level from baseline
Change in serum ALT concentration compared with baseline.
Measured: 24 hours, 72 hours, 7 days，14 days after injection.
Change in AST (Aspartate Aminotransferase) level from baseline
Change in serum AST concentration compared with baseline.
Measured: 24 hours, 72 hours, 7 days，14 days after injection.
Change in Interleukin-6 (IL-6) levels from baseline
Change in serum Interleukin-6 (IL-6) levels compared with baseline.
Measured: 24 hours, 72 hours, 7 days，14 days after injection.
Need for mechanical ventilation
Need for mechanical ventilation is defined as requiring invasive or non-invasive positive pressure ventilation for at least 1 hour due to respiratory failure.
Measured: From the end of the drug infusion until ICU discharge (up to 30 days).
Duration of mechanical ventilation
Duration of mechanical ventilation is defined as the total number of hours from the initiation of invasive or non-invasive ventilation until the last successful extubation
Measured: From the initiation of mechanical ventilation until ICU discharge (up to 30 days).
Requirement for left ventricular assist device implantation
Requirement for left ventricular assist device implantation is defined as the need for implantation of a left ventricular assist device as bridge-to-transplant or destination therapy in patients with cardiogenic shock or end-stage heart failure who fail to maintain adequate end-organ perfusion despite optimized medical therapy.
Measured: From the end of iCDC infusion through study completion (up to 30 days).
Duration of left ventricular assist device use
Duration of left ventricular assist device use is defined as the total time from completion of device implantation until device removal, patient death, or the study cutoff date, whichever occurs first.
Measured: From left ventricular assist device implantation through study completion (up to 30 days).
Simplified Acute Physiology Score II
The Simplified Acute Physiology Score II (SAPS II) is a validated severity-of-disease scoring system used to assess the physiological status of critically ill patients. The score ranges from 0 to 163, with higher scores indicating greater disease severity and a worse prognosis. SAPS II will be calculated based on the worst physiological values recorded during each 24-hour period.
Measured: Daily from ICU admission through ICU discharge (up to 30 days).
time to recovery from cardiogenic shock
Time to recovery from cardiogenic shock is defined as the duration from the end of the single study drug infusion to the achievement of predefined criteria for hemodynamic stability and improvement in end-organ perfusion.
Measured: From the end of iCDC infusion to recovery from cardiogenic shock, assessed continuously until ICU discharge (up to 30 days).
length of stay at the intensive care unit
Length of stay in the ICU is defined as the total time from ICU admission until ICU discharge.
Measured: From ICU admission until ICU discharge (up to 30 days).
Length of hospital stay;
Total hospital length of stay is defined as the total calendar days from patient admission registration until final discharge or death, whichever occurs first.
Measured: From hospital admission until hospital discharge or death (up to 30 days).
Left ventricular ejection fraction (LVEF)
The difference of LVEF from baseline. LVEF will be assessed by echo.
Measured: 1 month after injection
SCAI Shock Classification
The SCAI shock classification is a standardized, five-stage system (from A to E) used to categorize the severity of cardiogenic shock based on clinical, hemodynamic, and biomarker criteria.
Measured: 3 days、7 days、14 days after injection
assessment of heart failure symptom
The difference of heart failure symptom, which will be assessed by NYHA grading and KCCQ score.
Measured: 1 month after injection
Incidence of major adverse cardiovascular events (MACE)
Incidence of Cardiac death, readmission due to heart failure.
Measured: 1 month after injection
incidence of adverse events
Incidence of adverse events of heart, nerve system, mental system, digestive system and immune system.
Measured: From the end of the drug infusion through study completion，up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start20 Jan 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinyang Hu, PhD, Principal investigator, Second Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380659
- Sponsor's protocol ID
- YAN2025-1716
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Allogeneic Immunosuppressive CAR-DC Targeting FAP in the Treatment of Acute Myocardial Infarction With Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT07380659
- Acronym / sponsor ID
- YAN2025-1716
- Conditions
- Cardiogenic Shock, Cardiogenic Shock Post Myocardial Infarction, STEMI - ST Elevation Myocardial Infarction
- Keywords
- acute myocardial infarction with cardiogenic shock
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 2 Feb 2026 (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.
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.
Detailed description
Background: Cardiogenic shock following acute myocardial infarction (AMI) remains a major unresolved clinical challenge. Despite advances in urgent revascularization and mechanical circulatory support, short-term mortality remains unacceptably high, approaching 40% within 30 days. Few evidence-based therapies have demonstrated a meaningful survival benefit, highlighting the urgent need for novel, mechanism-driven interventions. Growing clinical and experimental evidence indicates that a dysregulated systemic inflammatory response-manifested by hyperthermia, leukocytosis, and elevated proinflammatory mediators-plays a central role in the pathophysiology and progression of cardiogenic shock. Excessive inflammation exacerbates myocardial dysfunction, promotes multiorgan injury, and impairs recovery, suggesting that targeted immunomodulation may represent a complementary therapeutic strategy in this high-risk population. Dendritic cells (DCs), as professional antigen-presenting cells, occupy a pivotal position at the interface of innate and adaptive immunity and are uniquely suited to orchestrate context-dependent immune responses. In particular, tolerogenic DCs exert potent immunosuppressive effects through regulatory cytokine production, expression of co-inhibitory ligands, antigen-specific suppression of effector T cells, and induction of regulatory T cells. Collectively, these properties render DCs an attractive yet underexplored cellular platform for resolving excessive inflammation and promoting tissue repair in cardiogenic shock with AMI.
Purpose: In this prospective clinical study, the investigators engineered a stable, immunosuppressive, and fibrotic lesion-targeted DC therapy, termed immunosuppressive DCs (iCDC). This study was designed to evaluate the safety and preliminary efficacy of allogeneic fibroblast activation protein (FAP)-targeted iCDC therapy in patients with AMI complicated by cardiogenic shock.
Study design: This single-center, prospective, concurrent non-randomized controlled clinical trial enrolls patients aged 18-80 years presenting with acute myocardial infarction complicated by cardiogenic shock. Eligible patients are treated with allogeneic FAP-targeted immunosuppressive iCDC therapy.
Outcome measure: The primary outcome is the safety of FAP-targeted immunosuppressive iCDC therapy in patients with AMI complicated by cardiogenic shock. Secondary outcomes include 30-day all-cause mortality; hemodynamic parameters following iCDC therapy (systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate); time to hemodynamic stabilization; dose and duration of vasopressor and inotropic support; arterial lactate levels; changes in biomarkers (BNP, CRP, creatinine, ALT, AST, and inflammatory mediators); need for and duration of mechanical ventilation; need for and duration of left ventricular assist device implantation; intensive care unit and total hospital length of stay; left ventricular ejection fraction assessed by echocardiography; SAPS II score; SCAI shock classification; heart failure symptom burden assessed by NYHA functional class and the Kansas City Cardiomyopathy Questionnaire; incidence of major adverse cardiovascular events (MACE), including cardiac death and heart failure hospitalization; and incidence of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Administration of allogeneic FAP iCDC | Experimental | Biological: FAP allogeneic immunosuppressive CAR-DCAdministration of FAP immunosuppressive CAR-DC cell therapy in AMI CS. Patients are planned to be enrolled in the dose-escalation trial (1×10^5/kg、4×10^5/kg、and 8×10^5/kg) .The first dose group (4×10⁵/kg) initially enrolls 3 subjects to observe Dose-Limiting Toxicity (DLT) responses. 1. If no DLT occurs and all 3 subjects demonstrate efficacy after 6 months of treatment, and this dose is determined as the safe and effective dose. 2. If 1 subject experiences DLT, 3 additional subjects are enrolled. ·If 1/6 subjects develops DLT, and efficacy is not fully achieved in all 6 subjects, escalate to the next dose group (8×10^5/kg). ·If ≥2/6 subjects develop DLT, de-escalate to the previous dose group (1×10^5/kg). 3. After identifying a safe and effective dose, enrollment will be expanded at this dose to bring the total sample size to 8-10 subjects, to further evaluate safety and efficacy. |
| Standard therapy | No intervention | –Patients in the control group do not receive cellular therapy intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥ 18 years and < 80 years.
- Acute ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock, meeting all the following conditions:
- The patient or their legally authorized representative is capable of providing verbal confirmation of understanding the trial risks, benefits, and treatment alternatives associated with receiving immunosuppressive CAR-DC therapy, and provides written informed consent prior to participation in this clinical trial.
- Age ≥ 18 years and ≤ 75 years.
- Has provided written informed consent.
Key exclusion criteria (18 listed)
- Acute mechanical complications of infarction (e.g., ventricular septal rupture, acute mitral regurgitation).
- Cardiac arrest.
- Hypoxic-ischemic brain injury (cerebral injury with fixed and dilated pupils not attributable to medication).
- Shock due to other causes (e.g., sepsis, hypovolemia).
- Resuscitation duration >30 minutes.
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 |
|---|---|---|
| FAP allogeneic immunosuppressive CAR-DCEach subject receive FAP immunosuppressive CAR-DC by intravenous infusion at the first day of shock. | Biological | Administration of allogeneic FAP iCDC |
Primary outcome
The proportion of subjects with Dose-limiting toxicity (DLT)
Time frame: in 14 days after injection
The proportion of participants with DLT as assessed by CTCAE v5.0
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: in 14 days after injection
Incidence of iCDC treatment-emergent adverse events
29 secondary outcomes
All-cause mortality
Time frame: 30 days after injection
Systolic blood pressure
Time frame: 24 hours、48 hours、72 hours、7 days after injection
Diastolic blood pressure
Time frame: 24 hours、48 hours、72 hours、7 days after injection
Mean arterial pressure
Time frame: 24 hours、48 hours、72 hours、7 days after injection
Time to hemodynamic stability
Time frame: From the end of the iCDC infusion to achievement of hemodynamic stability, assessed continuously until ICU discharge (up to 30 days).
Dose of vasopressors
Time frame: 24 hours、48 hours、72 hours、7 days after injection
Duration of vasopressor use
Time frame: From enrollment to hospital discharge (up to 30 days).
Dose of inotropic drugs
Time frame: 24 hours、48 hours、72 hours、7 days after injection
Duration of inotropic drugs use
Time frame: From enrollment to hospital discharge (up to 30 days).
Serum lactate level
Time frame: The measurement frequency is once every 8 hours for a duration of 48 hours.
Change in B-type natriuretic peptide (BNP) level from baseline
Time frame: 7 days，14 days，30 days after injection.
Change in C-reactive protein (CRP) level from baseline
Time frame: 24 hours, 72 hours, 7 days，14 days after injection.
Change in serum creatinine level from baseline
Time frame: 24 hours, 72 hours, 7 days，14 days after injection.
Change in ALT (Alanine Aminotransferase) level from baseline
Time frame: 24 hours, 72 hours, 7 days，14 days after injection.
Change in AST (Aspartate Aminotransferase) level from baseline
Time frame: 24 hours, 72 hours, 7 days，14 days after injection.
Change in Interleukin-6 (IL-6) levels from baseline
Time frame: 24 hours, 72 hours, 7 days，14 days after injection.
Need for mechanical ventilation
Time frame: From the end of the drug infusion until ICU discharge (up to 30 days).
Duration of mechanical ventilation
Time frame: From the initiation of mechanical ventilation until ICU discharge (up to 30 days).
Requirement for left ventricular assist device implantation
Time frame: From the end of iCDC infusion through study completion (up to 30 days).
Duration of left ventricular assist device use
Time frame: From left ventricular assist device implantation through study completion (up to 30 days).
Simplified Acute Physiology Score II
Time frame: Daily from ICU admission through ICU discharge (up to 30 days).
time to recovery from cardiogenic shock
Time frame: From the end of iCDC infusion to recovery from cardiogenic shock, assessed continuously until ICU discharge (up to 30 days).
length of stay at the intensive care unit
Time frame: From ICU admission until ICU discharge (up to 30 days).
Length of hospital stay;
Time frame: From hospital admission until hospital discharge or death (up to 30 days).
Left ventricular ejection fraction (LVEF)
Time frame: 1 month after injection
SCAI Shock Classification
Time frame: 3 days、7 days、14 days after injection
assessment of heart failure symptom
Time frame: 1 month after injection
Incidence of major adverse cardiovascular events (MACE)
Time frame: 1 month after injection
incidence of adverse events
Time frame: From the end of the drug infusion through study completion，up to 30 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Xinyang Hu, PhD principal investigator
Second Affiliated Hospital, School of Medicine, Zhejiang University, China
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 FAP allogeneic immunosuppressive CAR-DC in people with Cardiogenic Shock and Cardiogenic Shock Post Myocardial Infarction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 14 inclusion and 18 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: opening soon, as of the sponsor's last update on 2 Feb 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiamin Li, MD (86-18868112006, 21818216@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects with Dose-limiting toxicity (DLT) (time frame: in 14 days after injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2026.