Heart failure stem cell trial pulled before it began
NCT ID NCT06840275
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 However, the study was withdrawn before enrolling anyone, so no data was collected.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- This trial was withdrawn before any participants were enrolled, so no results are available.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
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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 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: * 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
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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.