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Heart failure stem cell trial pulled before it began

NCT ID NCT06840275

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial aimed to test whether infusions of stem cells from donated fat tissue could improve heart function in people recently diagnosed with non-ischemic heart failure. Participants would have received two infusions a month apart. However, the study was withdrawn before enrolling anyone, so no data was collected.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
allogeneic adipose tissue-derived mesenchymal stem cells (C2C_ASC110)
What this could lead to
If this approach had worked, it could have pointed toward a new treatment to improve heart function in people with heart failure.
What could go wrong
This trial was withdrawn before any participants were enrolled, so no results are available. The approach was still experimental and early-stage.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 reasons such as: chronic obstructive pulmonary disease (COPD) with forced expiratory volume (FEV) \< 1 L/min or body mass index \> 35kg/m2 * Clinically significant anaemia (haemoglobin \< 6 mmol/L), leukopenia (leucocytes \< 2 109/L), leucocytosis (leucocytes \>14 109/L) or thrombocytopenia (thrombocytes \< 50 109/L) * History with malignant disease within five years of inclusion or current suspected malignancy - except treated skin cancer other than melanoma * Patients with known hypersensitivity to DMSO and Dextran-40. * Pregnant women * Other experimental treatment within four weeks from baseline tests * Participation in another interventional trial

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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.

Contacts and locations

Locations

  • Cardiology Stem Cell Centre, Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Denmark

    Copenhagen, 2100, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.