Safety and Efficacy of FAP iCDC in End-stage Dilated Cardiomyopathy
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
About this trial
To study the safety and efficacy of fibroblast activation protein (FAP)-targeted immunosuppressive chimeric antigen receptor-dendritic cell (CAR-DC) in the treatment of end-stage dilated cardiomyopathy and provide a new method for the treatment of end-stage dilated cardiomyopathy.
Eligibility criteria
Qualifiers
Age between 18 years old and 75 years old, diagnosed with dilated cardiomyopathy.
Able to verbally confirm that he/she understands the risks, benefits and treatment options of the iCDC trial. He/she or his/her legal representative provides written informed consent before participating in the clinical trial.
Diagnosed with Heart Failure with reduced ejection fraction (HFrEF), optimized drug therapy (under maximum tolerance of GDMT) for at least 3 months, left ventricular ejection fraction <35%, NYHA functional class ⅢB-IV, INTERMACS class 3-6.
Blood test: hematocrit >30%, lymphocytes >0.5×10^9/L, platelets >60×10^9/L.
Disqualifiers
History of myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks before enrollment.
CRT implanted within 12 weeks before enrollment or intended to implant CRT device.
Previous heart transplantation or implantation of a ventricular assist device or similar device, or planned implantation of a ventricular assist device or similar device.
Heart failure caused by ischemic cardiomyopathy, restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, long-standing hypertension, congenital structural heart disease, or uncorrected primary valvular disease.
Trial design
Treatments tested in this trial
- FAP immunosuppressive CAR-DC
Treatment groups
43 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov