ASCs in Recently Diagnosed Non-ischemic Heart Failure

NCT ID: NCT06840275

Last Updated: 2026-02-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2028-09-01

Brief 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.

Detailed Description

Non-ischemic heart failure (NIHF) is the leading reason for heart transplantation. The disease can be caused by several different factors, which include genetic disposition, inflammation, hypertension, alcohol consumption, and arrhythmia. Regardless of the aetiology, immune activation in myocardium leads to collagen deposition and decreases the function of heart. There are currently no treatment options, which reverse the inflammatory component in NIHF.

For the past decade, cell therapy has been tested as treatment option for ischemic and non-ischemic heart failure. Especially the mesenchymal stromal cell (MSC) has shown encouraging results for their potential to improve cardiac function in patients with non-ischemic heart failure along with its safety. The cardiac improvement may be related to the immunomodulation as MSC is known by its ability to modulate the immune system and has successfully been applied clinically as a novel active immunosuppressor.

We aim to conduct a clinical trial in which patients recently diagnosed with NIHF will be randomized to either treatment with two intravenous infusions of allogeneic MSCs obtained from adipose tissue (C2C_ASC110) or placebo (Cryostor® CS10) 4 weeks apart. The objective is to evaluate the safety and effect of MSCs on cardiac function.

The long-term perspective is that the information gathered from this study can lead to a new treatment option for this specific group of patients, who currently have no further treatment options and a poor prognosis.

Conditions

Non-Ischemic Heart Failure; Reduced Ejection Fraction Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Allogeneic adipose tissue-derived mesenchymal stromal cells (C2C_ASC110)

Intravenous infusion of allogeneic adipose tissue-derived mesenchymal stromal cells (C2C\_ASC110) 1 month apart.

Group Type: EXPERIMENTAL

Allogeneic adipose tissue-derived mesenchymal stem cells

Intervention Type: DRUG

Two intravenous infusions of C2C\_ASC110 1 month apart. The C2C\_ASC110 product contains 110 million cells.

CryoStor® CS10

Intravenous infusion of CryoStor® CS10 1 month apart.

Group Type: PLACEBO_COMPARATOR

Cryostor CS10

Intervention Type: OTHER

Two intravenous infusions of CryoStor CS10 1 month apart.

Interventions

Allogeneic adipose tissue-derived mesenchymal stem cells

Two intravenous infusions of C2C\_ASC110 1 month apart. The C2C\_ASC110 product contains 110 million cells.

Intervention Type: DRUG

Cryostor CS10

Two intravenous infusions of CryoStor CS10 1 month apart.

Intervention Type: OTHER

Other Intervention Names

C2C_ASC110

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cell to Cure ApS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abbas A Qayyum, MD MSc PhD

Role: PRINCIPAL_INVESTIGATOR

Cardiology Stem Cell Centre, Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen

Locations

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

Copenhagen, , Denmark

Countries

Denmark

Central Contacts

Jens Kastrup, MD DMSc

Role: CONTACT

jk@cell2cure.com

+45 21202994

Facility Contacts

Abbas A Qayyum, MD MSc PhD

Role: primary

abbas.ali.qayyum@regionh.dk

+4540219173

Other Identifiers

2025-520837-22-00

Identifier Type: CTIS

Identifier Source: secondary_id

U1111-1315-7011

Identifier Type: OTHER

Identifier Source: secondary_id

ARIISE

Identifier Type: -

Identifier Source: org_study_id