WithdrawnPhase 2

ASCs in Recently Diagnosed Non-ischemic Heart Failure

Stopped: Due to changes in company structure and investment the trial will not be initiated.

Denmark0Started 2026-03-01

Plain-language summary

The goal of this clinical trial is to investigate the efficacy and safety of intravenous infusions of allogeneic adipose tissue-derived mesechymal stromal cells in patients with recently diagnosed non-ischemic heart failure in restoring cardiac function compared to placebo. The primary outcome of this trial is the change in left ventricular ejection fraction 6 month after treatment compared to placebo. Participants will be given two treatments with one month apart of either allogeneic adipose tissue-derived mesechymal stromal cells or placebo.

Who can participate

Age range

18 Years – 100 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: * Patients above 18 years of age * Written informed consent * Anticipated to be able to participate during the entire study period * Diagnosed with non-ischemic heart failure with initial LVEF ≤ 40% and then up-titrated to maximal tolerable heart failure medication within the last 12 months * Symptomatic heart failure (NYHA II-III) * LVEF ≤ 45 % documented by echocardiography, CT or MRI performed after up-titration of heart failure medication (documentation of reduced LVEF at least after 1 and 3 months if implantation of a device either an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronisation Therapy (CRT), respectively) * Plasma Pro-BNP \> 300 pg/ml (\> 35 pmol/L) in patients with sinus rhythm and plasma Pro-BNP \> 422 pg/ml (\> 49 pmol/L) in patients with atrial fibrillation. Exclusion Criteria: * NYHA I or IV heart failure * Documented ischemic heart failure * On-going alcohol abuse * Implantation of CRT within 3 months or ICD within 1 month * Acute coronary syndrome with elevation of CKMB (Creatine Phosphatase-Myocardial Band) or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion * Expected to undergo screening for heart transplantation during the study time * Listed for heart transplantation * Other cardiac revascularization treatments to be performed * Moderate to severe aortic stenosis (valve area \< 1.1 cm2) or clinically significant mitral valve disease * Diminished functional capacity for other …

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Change in left ventricular ejection fraction (I)

Timeframe: From enrollment to 6 months after the last infusion of C2C_ASC110 and placebo.

Trial details

NCT IDNCT06840275

SponsorCell to Cure ApS

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-09-01

View on ClinicalTrials.gov More Non-Ischemic Heart Failure trials