NCT06840275

ASCs in Recently Diagnosed Non-ischemic Heart Failure

A Danish, Double-blind, Randomized Placebo-controlled Clinical Trial Evaluating Allogeneic Adipose Tissue Derived Mesenchymal Stromal Cell Therapy in Patients With Recently Diagnosed Non-ishemic Heart Failure With Reduced Ejection Fraction

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Cell to Cure ApS · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Allogeneic adipose tissue-derived mesenchymal stem cells	Two intravenous infusions of C2C\_ASC110 1 month apart. The C2C\_ASC110 product contains 110 million cells.
OTHER	Cryostor CS10	Two intravenous infusions of CryoStor CS10 1 month apart.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2025-02-21
• Last updated: 2026-04-01

Locations

1 site across 1 country: Denmark