Ischemic CardiomyopathyPhase 1NCT07505199
Safety and Efficacy of FAP iCDC in Ischemic Cardiomyopathy
A Phase 1 study testing autologus FAP-targeted immunosuppressive CAR-DCs (iCDC) and Standard medical treatment in people with Ischemic Cardiomyopathy and Cell Therapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study aims to evaluate the safety and efficacy of fibroblast activation protein (FAP)-targeted autologous immunosuppressive chimeric antigen receptor dendritic cell (iCDC) therapy in patients with ischemic cardiomyopathy, and to explore its potential as a novel therapeutic strategy for this disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ischemic Cardiomyopathy, Cell Therapy
- What is being tested?
- autologus FAP-targeted immunosuppressive CAR-DCs (iCDC) and Standard medical treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2026to 1 Apr 2029
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and ≤75 years.
- Diagnosis of ischemic cardiomyopathy, with at least 3 months of optimized guideline-directed medical therapy (GDMT) at maximally tolerated doses; left ventricular ejection fraction (LVEF) <35%; New York Heart Association (NYHA) functional class III-IV.
- Ability to understand the risks, benefits, and treatment alternatives of immunoregulatory CAR-DC therapy, and willingness to participate in the study; the patient or his/her legally authorized representative must provide written informed consent prior to study enrollment.
- Adequate hematologic function defined as: hematocrit >30%, lymphocyte count >0.5 × 10⁹/L, and platelet count >60 × 10⁹/L.
Who cannot join
- Life expectancy <1 year due to non-cardiac conditions.
- Cardiac resynchronization therapy (CRT) implantation within 3 months prior to enrollment or planned CRT implantation.
- Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 3 months prior to enrollment OR plan to PCI.
- Presence of non-ischemic cardiomyopathy, including but not limited to dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, arrhythmogenic cardiomyopathy, peripartum cardiomyopathy, inflammatory or immune-mediated cardiomyopathy, metabolic or genetic cardiomyopathy, or cardiomyopathy secondary to moderate-to-severe valvular heart disease, congenital heart disease, or other non-ischemic etiologies.
- Persistent hemodynamic instability.
- End-stage renal disease (eGFR <25 mL/min/1.73 m²) requiring or receiving renal replacement therapy (hemodialysis or peritoneal dialysis).
Show all 11Show fewer
- Active autoimmune disease requiring immunosuppressive therapy.
- History of malignancy.
- Active infection, including but not limited to active hepatitis B (HBV DNA >1000 copies/mL by PCR), hepatitis C, syphilis, or human immunodeficiency virus (HIV) infection, or uncontrolled systemic fungal, bacterial, viral, or other infections.
- Pregnant women.
- Known contraindications to the investigational product or study-related procedures.
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, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang / 浙江, 310009
Jiamin Li, Dr, 18868112006, 21818216@zju.edu.cn
21818216@zju.edu.cn
About this study
Official title: Safety and Efficacy of FAP-Targeted Immunosuppressive CAR-DC in the Treatment of Ischemic Cardiomyopathy
This study aims to evaluate the safety and efficacy of fibroblast activation protein (FAP)-targeted autologous immunosuppressive chimeric antigen receptor dendritic cell (iCDC) therapy in patients with ischemic cardiomyopathy, and to explore its potential as a novel therapeutic strategy for this disease.
Read the detailed description
Ischemic heart disease (IHD) is becoming an increasingly serious global public health challenge due to its rising prevalence and the continuous increase in human life expectancy. Despite substantial advances in reperfusion therapy, pharmacological treatment, and risk factor management in recent decades, clinical prognosis remains poor. Many patients continue to experience adverse cardiac remodeling after the initial ischemic injury and eventually progress to heart failure. This persistent residual risk suggests that current therapeutic strategies do not fully address key pathogenic mechanisms underlying disease progression. Inflammation plays a central role in linking acute myocardial injury to chronic cardiac remodeling.
Dendritic cells (DCs), as professional antigen-presenting cells, function at the interface between innate and adaptive immunity and play a critical role in coordinating immune responses within the tissue microenvironment. Recent advances in the study of tolerogenic dendritic cells (tolerogenic DCs) have provided new insights into their potential application in cardiovascular diseases. Unlike conventional immunostimulatory DCs, tolerogenic DCs can induce antigen-specific immune tolerance through multiple mechanisms, including secretion of regulatory cytokines, expression of co-inhibitory ligands, suppression of effector T-cell responses, and induction of regulatory T cells. These properties make DCs a promising but underexplored platform for immune modulation.
This study evaluates a novel therapeutic strategy using fibroblast activation protein (FAP)-targeted autologous immunosuppressive chimeric antigen receptor dendritic cell (CAR-DC) therapy, also referred to as iCDC therapy, in patients with ischemic cardiomyopathy. This approach is designed to direct engineered dendritic cells to sites of cardiac injury and fibrosis, with the goal of modulating the balance between injurious and reparative immune responses. By targeting local immune regulation at the site of injury, this strategy may help attenuate adverse cardiac remodeling while potentially avoiding the systemic immunosuppression associated with conventional therapies.
- Conditions
- Ischemic Cardiomyopathy, Cell Therapy
- Being tested
- autologus FAP-targeted immunosuppressive CAR-DCs (iCDC), Standard medical treatment
- Keywords
- ischemic cardiomyopathy, dendritic cell, immune tolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologus FAP-targeted immunosuppressive CAR-DCs (iCDC)Biological
Each subject receives FAP-targeted immunosuppressive CAR-DCs by intravenous infusion after enrollment.
Standard medical treatmentOther
Participants receive standard medical treatment for ischemic cardiomyopathy according to current clinical practice and guideline-directed medical therapy. No iCDC therapy is administered in this arm.
| Study group | Role | What they receive |
|---|---|---|
| Administration of autologus FAP iCDC | Experimental | Administration of FAP immunosuppressive CAR-DC cell therapy in ischemic cardiomyopathy. 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 15 subjects, to further evaluate safety and efficacy. Receives: Biological: autologus FAP-targeted immunosuppressive CAR-DCs (iCDC) |
| Standard treatment control | Active comparator | Participants in this arm will receive standard medical treatment for ischemic cardiomyopathy according to current clinical practice and guideline-directed medical therapy. These participants will not receive iCDC therapy but will undergo scheduled follow-up assessments for safety and efficacy comparisons. Receives: Other: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLT)
Incidence of dose-limiting toxicities (DLT) within 14 days after administration of FAP-targeted immunoregulatory CAR-DC therapy
Measured: Within 14 days after treatment
Incidence of Treatment-Emergent Adverse Events (TEAE)
Incidence of treatment-emergent adverse events (TEAE) occurring within 6 months after treatment in patients with ischemic cardiomyopathy.
Measured: Within 6 months after treatment
Secondary outcomes (20)
Change in Left Ventricular Ejection Fraction (LVEF) by Echocardiography
Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiography, and between-group difference between the iCDC treatment group and the standard treatment control group.
Measured: Baseline, 3 months, 6 months
Change in left ventricular end-systolic volume (LVESV) as assessed by Echocardiography
Change from baseline in left ventricular end-systolic volume (LVESV)measured by echocardiography, and between-group difference between the iCDC treatment group and the standard treatment control group.
Measured: Baseline, 3 months, and 6 months
Change in left ventricular end-diastolic volume (LVEDV) by Echocardiography
Change from baseline in left ventricular end-diastolic volume (LVEDV) measured by echocardiography, and between-group difference between the iCDC treatment group and the standard treatment control group.
Measured: Baseline, 3 months, and 6 months
Change in global longitudinal strain (GLS) measured by Echocardiography
Change from baseline in global longitudinal strain (GLS) measured by echocardiography, and between-group difference between the iCDC treatment group and the standard treatment control group.
Measured: Baseline, 3 months, 6 months
Change in wall motion score index (WMSI) measured by Echocardiography
Change from baseline in wall motion score index (WMSI) measured by echocardiography, and between-group difference between the iCDC treatment group and the standard treatment control group.
Measured: Baseline, 3 months, 6 months
Change in left ventricular ejection fraction (LVEF) by Cardiac Magnetic Resonance Imaging
Change from baseline in left ventricular ejection fraction (LVEF) measured by cardiac magnetic resonance imaging, and between-group difference between the iCDC treatment group and the standard treatment control group.
Measured: Baseline, 6 months
Change in left ventricular end-systolic volume (LVESV) by Cardiac Magnetic Resonance Imaging
Change from baseline in left ventricular end-systolic volume (LVESV) measured by cardiac magnetic resonance imaging, and between-group difference between the iCDC treatment group and the standard treatment control group.
Measured: Baseline and 6 months
Change in left ventricular end-diastolic volume (LVEDV) by Cardiac Magnetic Resonance Imaging
Change from baseline in left ventricular end-diastolic volume (LVEDV) measured by cardiac magnetic resonance imaging, and between-group difference between the iCDC treatment group and the standard treatment control group.
Measured: Baseline, 6 months
Change in stroke volume (SV) by Cardiac Magnetic Resonance Imaging
Change from baseline in stroke volume (SV) measured by cardiac magnetic resonance imaging, and between-group difference between the iCDC treatment group and the standard treatment control group.
Measured: Baseline and 6 months
Change in Myocardial Late Gadolinium Enhancement Volume by Cardiac Magnetic Resonance Imaging
Change from baseline in myocardial late gadolinium enhancement (LGE) volume percentage measured by cardiac magnetic resonance imaging, and between-group difference between the iCDC treatment group and the standard treatment control group.
Measured: Baseline and 6 months
Change in Extracellular Volume Fraction in Remote Myocardium by Cardiac Magnetic Resonance Imaging
Change from baseline in extracellular volume fraction (ECV) in remote myocardium measured by cardiac magnetic resonance imaging, and between-group difference between the iCDC treatment group and the standard treatment control group.
Measured: Baseline and 6 months
Change in Myocardial Scar Transmurality by Cardiac Magnetic Resonance Imaging
Change from baseline in myocardial scar transmurality percentage measured by cardiac magnetic resonance imaging, and between-group difference between the iCDC treatment group and the standard treatment control group.
Measured: Baseline and 6 months
Change in Serum B-type Natriuretic Peptide (BNP) Level
Change from baseline in serum B-type natriuretic peptide (BNP) level, and between-group difference between the iCDC treatment group and the standard treatment control group.
Measured: Baseline, 3 months, and 6 months
Change in Six-Minute Walk Test Distance
Change from baseline in six-minute walk test distance, and between-group difference between the iCDC treatment group and the standard treatment control group.
Measured: Baseline, 3 months, and 6 months
Change in Heart Failure Symptom Assessments--NYHA
Change from baseline in heart failure symptom and functional status assessments, including New York Heart Association (NYHA) functional class, and between-group difference between the iCDC treatment group and the standard treatment control group.
Measured: Baseline, 3 months, and 6 months
Change in Heart Failure Symptom Assessments--INTERMACS
Change from baseline in heart failure symptom and functional status assessments, including INTERMACS profile, and between-group difference between the iCDC treatment group and the standard treatment control group.
Measured: Baseline, 3 months, and 6 months
Change in Heart Functional Status Assessments-KCCQ
Change from baseline in heart failure symptom and functional status assessments, including Kansas City Cardiomyopathy Questionnaire (KCCQ) score, and between-group difference between the iCDC treatment group and the standard treatment control group.
Measured: Baseline, 3 months, and 6 months
Change in Cardiac 18F-FAPI Uptake by PET/CT
Change from baseline in cardiac 18F-FAPI maximum standardized uptake value (SUVmax) measured by positron emission tomography/computed tomography (PET/CT), and between-group difference between the iCDC treatment group and the standard treatment control group.
Measured: Baseline and 6 months
Incidence of Major Adverse Cardiovascular Events
Incidence of major adverse cardiovascular events (MACE), including all-cause death, hospitalization for heart failure, myocardial infarction, and stroke, in the iCDC treatment group and the standard treatment control group.
Measured: Up to 6 months
Incidence of Adverse Events
Incidence of adverse events in the iCDC treatment group and the standard treatment control group. Adverse events will be assessed according to the Common Terminology Criteria for Adverse Events, version 5.0.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start21 May 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic CardiomyopathyStudies 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
- Model description
- Participants will be assigned in parallel to either the iCDC treatment group or the standard treatment control group. Assignment will be based on participants' treatment preference; therefore, this is a non-randomized, open-label study.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505199
- Sponsor's protocol ID
- YAN2026-0257
- Status last verified
- Jun 2026
- First submitted
- 26 Mar 2026
- Last updated
- 2 Jul 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 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of FAP-Targeted Immunosuppressive CAR-DC in the Treatment of Ischemic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT07505199
- Acronym / sponsor ID
- YAN2026-0257
- Conditions
- Ischemic Cardiomyopathy, Cell Therapy
- Keywords
- ischemic cardiomyopathy, dendritic cell, immune tolerance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 21 May 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 1 Apr 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.
This study aims to evaluate the safety and efficacy of fibroblast activation protein (FAP)-targeted autologous immunosuppressive chimeric antigen receptor dendritic cell (iCDC) therapy in patients with ischemic cardiomyopathy, and to explore its potential as a novel therapeutic strategy for this disease.
Detailed description
Ischemic heart disease (IHD) is becoming an increasingly serious global public health challenge due to its rising prevalence and the continuous increase in human life expectancy. Despite substantial advances in reperfusion therapy, pharmacological treatment, and risk factor management in recent decades, clinical prognosis remains poor. Many patients continue to experience adverse cardiac remodeling after the initial ischemic injury and eventually progress to heart failure. This persistent residual risk suggests that current therapeutic strategies do not fully address key pathogenic mechanisms underlying disease progression. Inflammation plays a central role in linking acute myocardial injury to chronic cardiac remodeling.
Dendritic cells (DCs), as professional antigen-presenting cells, function at the interface between innate and adaptive immunity and play a critical role in coordinating immune responses within the tissue microenvironment. Recent advances in the study of tolerogenic dendritic cells (tolerogenic DCs) have provided new insights into their potential application in cardiovascular diseases. Unlike conventional immunostimulatory DCs, tolerogenic DCs can induce antigen-specific immune tolerance through multiple mechanisms, including secretion of regulatory cytokines, expression of co-inhibitory ligands, suppression of effector T-cell responses, and induction of regulatory T cells. These properties make DCs a promising but underexplored platform for immune modulation.
This study evaluates a novel therapeutic strategy using fibroblast activation protein (FAP)-targeted autologous immunosuppressive chimeric antigen receptor dendritic cell (CAR-DC) therapy, also referred to as iCDC therapy, in patients with ischemic cardiomyopathy. This approach is designed to direct engineered dendritic cells to sites of cardiac injury and fibrosis, with the goal of modulating the balance between injurious and reparative immune responses. By targeting local immune regulation at the site of injury, this strategy may help attenuate adverse cardiac remodeling while potentially avoiding the systemic immunosuppression associated with conventional therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned in parallel to either the iCDC treatment group or the standard treatment control group. Assignment will be based on participants' treatment preference; therefore, this is a non-randomized, open-label study.
| Arm | Type | Receives |
|---|---|---|
| Administration of autologus FAP iCDC | Experimental | Biological: autologus FAP-targeted immunosuppressive CAR-DCs (iCDC)Administration of FAP immunosuppressive CAR-DC cell therapy in ischemic cardiomyopathy. 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 15 subjects, to further evaluate safety and efficacy. |
| Standard treatment control | Active comparator | Other: Standard medical treatmentParticipants in this arm will receive standard medical treatment for ischemic cardiomyopathy according to current clinical practice and guideline-directed medical therapy. These participants will not receive iCDC therapy but will undergo scheduled follow-up assessments for safety and efficacy comparisons. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years and ≤75 years.
- Diagnosis of ischemic cardiomyopathy, with at least 3 months of optimized guideline-directed medical therapy (GDMT) at maximally tolerated doses; left ventricular ejection fraction (LVEF) <35%; New York Heart Association (NYHA) functional class III-IV.
- Ability to understand the risks, benefits, and treatment alternatives of immunoregulatory CAR-DC therapy, and willingness to participate in the study; the patient or his/her legally authorized representative must provide written informed consent prior to study enrollment.
- Adequate hematologic function defined as: hematocrit >30%, lymphocyte count >0.5 × 10⁹/L, and platelet count >60 × 10⁹/L.
Key exclusion criteria (11 listed)
- Life expectancy <1 year due to non-cardiac conditions.
- Cardiac resynchronization therapy (CRT) implantation within 3 months prior to enrollment or planned CRT implantation.
- Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 3 months prior to enrollment OR plan to PCI.
- Presence of non-ischemic cardiomyopathy, including but not limited to dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, arrhythmogenic cardiomyopathy, peripartum cardiomyopathy, inflammatory or immune-mediated cardiomyopathy, metabolic or genetic cardiomyopathy, or cardiomyopathy secondary to moderate-to-severe valvular heart disease, congenital heart disease, or other non-ischemic etiologies.
- Persistent hemodynamic instability.
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 |
|---|---|---|
| autologus FAP-targeted immunosuppressive CAR-DCs (iCDC)Each subject receives FAP-targeted immunosuppressive CAR-DCs by intravenous infusion after enrollment. | Biological | Administration of autologus FAP iCDC |
| Standard medical treatmentParticipants receive standard medical treatment for ischemic cardiomyopathy according to current clinical practice and guideline-directed medical therapy. No iCDC therapy is administered in this arm. | Other | Standard treatment control |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLT)
Time frame: Within 14 days after treatment
Incidence of dose-limiting toxicities (DLT) within 14 days after administration of FAP-targeted immunoregulatory CAR-DC therapy
Incidence of Treatment-Emergent Adverse Events (TEAE)
Time frame: Within 6 months after treatment
Incidence of treatment-emergent adverse events (TEAE) occurring within 6 months after treatment in patients with ischemic cardiomyopathy.
20 secondary outcomes
Change in Left Ventricular Ejection Fraction (LVEF) by Echocardiography
Time frame: Baseline, 3 months, 6 months
Change in left ventricular end-systolic volume (LVESV) as assessed by Echocardiography
Time frame: Baseline, 3 months, and 6 months
Change in left ventricular end-diastolic volume (LVEDV) by Echocardiography
Time frame: Baseline, 3 months, and 6 months
Change in global longitudinal strain (GLS) measured by Echocardiography
Time frame: Baseline, 3 months, 6 months
Change in wall motion score index (WMSI) measured by Echocardiography
Time frame: Baseline, 3 months, 6 months
Change in left ventricular ejection fraction (LVEF) by Cardiac Magnetic Resonance Imaging
Time frame: Baseline, 6 months
Change in left ventricular end-systolic volume (LVESV) by Cardiac Magnetic Resonance Imaging
Time frame: Baseline and 6 months
Change in left ventricular end-diastolic volume (LVEDV) by Cardiac Magnetic Resonance Imaging
Time frame: Baseline, 6 months
Change in stroke volume (SV) by Cardiac Magnetic Resonance Imaging
Time frame: Baseline and 6 months
Change in Myocardial Late Gadolinium Enhancement Volume by Cardiac Magnetic Resonance Imaging
Time frame: Baseline and 6 months
Change in Extracellular Volume Fraction in Remote Myocardium by Cardiac Magnetic Resonance Imaging
Time frame: Baseline and 6 months
Change in Myocardial Scar Transmurality by Cardiac Magnetic Resonance Imaging
Time frame: Baseline and 6 months
Change in Serum B-type Natriuretic Peptide (BNP) Level
Time frame: Baseline, 3 months, and 6 months
Change in Six-Minute Walk Test Distance
Time frame: Baseline, 3 months, and 6 months
Change in Heart Failure Symptom Assessments--NYHA
Time frame: Baseline, 3 months, and 6 months
Change in Heart Failure Symptom Assessments--INTERMACS
Time frame: Baseline, 3 months, and 6 months
Change in Heart Functional Status Assessments-KCCQ
Time frame: Baseline, 3 months, and 6 months
Change in Cardiac 18F-FAPI Uptake by PET/CT
Time frame: Baseline and 6 months
Incidence of Major Adverse Cardiovascular Events
Time frame: Up to 6 months
Incidence of Adverse Events
Time frame: Up to 6 months
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 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Ischemic Cardiomyopathy
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Left Ventricular Outflow Tract Obstruction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
Not yet recruitingObservational study
PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
Heart Failure, Coronary Artery Disease
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.
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 autologus FAP-targeted immunosuppressive CAR-DCs (iCDC) and Standard medical treatment in people with Ischemic Cardiomyopathy and Cell Therapy, 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 4 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 2 Jul 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?
Incidence of Dose-Limiting Toxicities (DLT) (time frame: Within 14 days after treatment). 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 Jul 2026.