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ARIISE - ASCs in recently diagnosed non-ischemic heart failure
EU CTIS ID: 2025-520837-22-00
What this study is testing
To investigate efficacy and safety of intravenous infusion of allogeneic adipose tissue-derived mesenchymal stromal stem cells (C2C_ASC110) in patients with recently diagnosed non-ischemic heart failure in restoring cardiac function compared to placebo (CryoStor CS10).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- > 18 years of age
- Diagnosed with non-ischemic heart failure with initial LVEF (left ventricular ejection fraction) ≤ 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 rhyth and plasma Pro BNP > 422 pg/ml (> 49 pmol/L) in patients with atrial fibrillation
You likely can't join if
- NYHA I or IV heart failure
- 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/m^2
- Clinically significant anaemia (haemoglobin < 6 mmol/L), leukopenia (leucocytes < 2x10^9/L), leucocytosis (leucocytes >14x10^9/L) or thrombocytopenia (thrombocytes < 50x10^9/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
See the full eligibility criteria
- > 18 years of age
- Diagnosed with non-ischemic heart failure with initial LVEF (left ventricular ejection fraction) ≤ 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 rhyth and plasma Pro BNP > 422 pg/ml (> 49 pmol/L) in patients with atrial fibrillation
- NYHA I or IV heart failure
- 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/m^2
- Clinically significant anaemia (haemoglobin < 6 mmol/L), leukopenia (leucocytes < 2x10^9/L), leucocytosis (leucocytes >14x10^9/L) or thrombocytopenia (thrombocytes < 50x10^9/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
- Documented ischemic heart failure
- Ongoing 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.