ASCs in Recently Diagnosed Non-ischemic Heart Failure

NCT06840275 | Withdrawn Phase 2 DMC

• 3 other identifiers: ARIISE2025-520837-22-00U1111-1315-7011
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Ischemic Heart Failure; Reduced Ejection Fraction Heart Failure

Keywords

allogeneic adipose tissue derived mesenchymal stromal cell; non-ischemic heart failure; mesenchymal stromal cell

Outcome Measures

Primary Outcomes (1)

• Change in left ventricular ejection fraction (I)

  Change in left ventricular ejection fraction 6 months after last C2C\_ASC110 infusion compared to the placebo group.

  From enrollment to 6 months after the last infusion of C2C_ASC110 and placebo.

Secondary Outcomes (9)

• Changes in left ventricular end systolic volume

  From enrollment to 7 months and to 12 months.

• Change in left ventricular ejection fraction (II)

  From enrollment to 7 months and to 12 months.

• Changes in left ventricular end diastolic volume

  From enrollment to 7 months and to 12 months.

• Change in NYHA classification

  From enrollment to 12 months.

• Change in KCCQ questionnaire score

  From enrollment to 12 months.

Study Arms (2)

Allogeneic adipose tissue-derived mesenchymal stromal cells (C2C_ASC110)

EXPERIMENTAL

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

Drug: Allogeneic adipose tissue-derived mesenchymal stem cells

CryoStor® CS10

PLACEBO COMPARATOR

Intravenous infusion of CryoStor® CS10 1 month apart.

Other: Cryostor CS10

Interventions

Allogeneic adipose tissue-derived mesenchymal stem cells DRUG

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

Also known as: C2C_ASC110

Allogeneic adipose tissue-derived mesenchymal stromal cells (C2C_ASC110)

Cryostor CS10 OTHER

Two intravenous infusions of CryoStor CS10 1 month apart.

CryoStor® CS10

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)
• 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

Sponsors & Collaborators

• Cell to Cure ApS: lead

Study Sites (1)

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

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Chaaban N, Kastrup J, Rossing K, Schou M, Hove J, Buch P, Ekblond A, Johansen EM, Norgaard MJ, Hojgaard LD, Qayyum AA. Adipose tissue-derived mesenchymal stromal cell therapy in nonischemic heart failure with reduced ejection fraction - ARIISE study design. Future Cardiol. 2026 Mar 25:1-9. doi: 10.1080/14796678.2026.2647879. Online ahead of print.

  PMID: 41879383 DERIVED

MeSH Terms

Conditions

Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Abbas A Qayyum, MD MSc PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 21, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)