Experimental cell therapy targets End-Stage heart disease
NCT ID NCT06902896
First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times
Summary
This early-stage trial tested a new cell therapy called CAR-DC in 8 people with end-stage dilated cardiomyopathy, a condition that weakens the heart. The therapy targets a protein called FAP to calm the immune system and improve heart function. The main goal was to check safety, with secondary measures looking at changes in the heart's pumping ability.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FAP-targeted immunosuppressive CAR-DC cells
- What this could lead to
- If it works, this could point toward a new cell therapy to control heart failure in end-stage dilated cardiomyopathy.
- What could go wrong
- This is a very early Phase 1 trial with only 8 people. It primarily tests safety, not effectiveness, and may not lead to a widely available treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 43 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Symptomatic bradycardia or second/third degree heart block. * Active autoimmune disease requiring immunosuppressive therapy. * Pulmonary Embolism (PE). * A history of tuberculosis. * History of severe renal failure or need for dialysis, creatinine \>2.5 mg/dl. * Uncorrected thrombocytopenia or systemic coagulopathy (platelet count \< 50,000, INR \> 2.5, or aPTT \> 2.5 times control in the absence of anticoagulation), or active bleeding and uncorrectable coagulopathy. * Aspartate aminotransferase or alanine aminotransferase levels greater than 5.0 times the upper limit of normal (ULN), total bilirubin \>3 mg/dl. * History of concurrent severe infection, hepatobiliary obstruction, or malignancy. * Infections: Active hepatitis B (PCR-detected hepatitis B virus DNA copies \> 1000), hepatitis C, syphilis, or human immunodeficiency virus (HIV) infection at screening; uncontrolled systemic fungal, bacterial, viral, or other pathogen infection. * Severe hemodynamic instability (eg, shock). * Women who are pregnant or may become pregnant. * Contraindications to study drugs or tests.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Second Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITINGHangzhou, Zhejiang, 310009, China
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