ARIISE - ASCs in recently diagnosed non-ischemic heart failure

2025-520837-22-00 Therapeutic exploratory (Phase II) Ended

End 27 Mar 2026 · Status Ended · 1 EU/EEA countries · 4 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ended
Participants planned 90
Countries 1
Sites 4

Non-ischemic heart failure with reduced ejection fraction

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).

Key facts

Sponsor
Cell2Cure ApS
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Cardiovascular Diseases [C14], Phenomena and Processes [G] - Immune system processes [G12], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
Trial duration
completed 27 Mar 2026
Decision date (initial)
2025-12-08
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2025-520837-22-00
WHO UTN
U1111-1315-7011
ClinicalTrials.gov
NCT06840275

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

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).

Conditions and MedDRA coding

Non-ischemic heart failure with reduced ejection fraction

VersionLevelCodeTermSystem organ class
20.0 LLT 10055222 Non-ischemic cardiomyopathy 10007541

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. > 18 years of age
  2. 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
  3. Symptomatic heart failure (NYHA II-III)
  4. 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)
  5. 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

Exclusion criteria 14

  1. NYHA I or IV heart failure
  2. Documented ischemic heart failure
  3. Ongoing alcohol abuse
  4. Implantation of CRT within 3 months or ICD within 1 month
  5. Acute coronary syndrome with elevation of CKMB (Creatine Phosphatase-Myocardial Band) or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion
  6. Expected to undergo screening for heart transplantation during the study time
  7. Listed for heart transplantation
  8. Other cardiac revascularization treatments to be performed
  9. Moderate to severe aortic stenosis (valve area < 1.1 cm2) or clinically significant mitral valve disease
  10. 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
  11. Clinically significant anaemia (haemoglobin < 6 mmol/L), leukopenia (leucocytes < 2x10^9/L), leucocytosis (leucocytes >14x10^9/L) or thrombocytopenia (thrombocytes < 50x10^9/L)
  12. History with malignant disease within five years of inclusion or current suspected malignancy – except treated skin cancer other than melanoma
  13. Patients with known hypersensitivity to DMSO and Dextran-40
  14. Pregnant women

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The primary efficacy endpoint is change in LVEF 6 months after last C2C_ASC110 infusion compared to the patient group treated with placebo (CryoStor CS10) infusion.

Secondary endpoints 3

  1. The secondary efficacy endpoint are changes in LVESV (left ventricular end-systolic volume), LVEF and LVEDV (left ventricular end-diastolic volume) at 7 and 12 months follow-up.
  2. Other secondary efficacy endpoints: changes in; NYHA classification; 6-minute walking test; KCCQ and EQ5D5L questionnaire; additional echocardiographic measures and Pro-BNP
  3. Safety endpoints are: incidence and severity of SARs (serious adverse reactions) and SUSARs (suspected unexpected serious adverse reactions) evaluated at 12 months follow-up

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

C2CASC110

PRD11957843 · Product

Active substance
Allogenic Adipose-Tissue-Derived Mesenchymal Stem Cells
Substance synonyms
CellReady
Pharmaceutical form
INFUSION
Route of administration
INFUSION
Max daily dose
110 million organisms million organisms
Max total dose
220 million organisms million organisms
Max treatment duration
1 Month(s)
Authorisation status
Not Authorised
MA holder
CELL2CURE APS
Paediatric formulation
No
Orphan designation
No

Placebo 1

CryoStor® CS10 is used as placebo. CryoStor® CS10 is a freezing medium for cells that contains DMSO. It has been used for cryopreservation of C2C_ASC110 and within the formulation of C2C_ASC110 formulation as excipient. It is serum-free, animal component-free product. It is manufactured according to cGMP principles. It is formulated with USP-grade components to minimize variability and contains 10% DMSO. CryoStor® 10 has been used as an excipient for cryopreservation of the EU marketed product Yescarta® EU/1/18/1299/001, a genetically modifies autologous cell-based product containing transduced T cells (0,4 -2x10^8 cells) for treatment of blood cancers. The product is also approved by US FDA and Health Canada. Thus, CryoStor® is not regarded as a novel excipient. A further description of CryoStor® CS10 are approachable in the IMPD of C2C_ASC110.

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Cell2Cure ApS

2 Total trials 2 Ended
Commercial
Sponsor organisation
Cell2Cure ApS
Address
Kajeroedgaard 9
City
Birkeroed
Postcode
3460
Country
Denmark

Scientific contact point

Organisation
Cell2Cure ApS
Contact name
Jens Kastrup

Public contact point

Organisation
Cell2Cure ApS
Contact name
Jens Kastrup

Third parties 1

OrganisationCity, countryDuties
GCP-enheden ved Københavns Universitetshospital
ORL-000010164
 Frederiksberg, Denmark On site monitoring

Locations

1 EU/EEA country · 4 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Ended 90 4
Rest of world — 0 —

Investigational sites

Denmark

4 sites · Ended
Copenhagen University Hospital
Department of Cardiology, Bispebjerg Bakke 23, 2400, Copenhagen Nv
Rigshospitalet
Department of Cardiology, Blegdamsvej 9, 2100, Copenhagen Oe
Herlev Hospital
Department of Heart Diseases, Borgmester Ib Juuls Vej 1, 2730, Herlev
Region Hovedstaden
Hvidovre Hospital Heart Centre, Kettegaard Alle 36, 2650, Hvidovre

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) Protocol ARIISE 5
Protocol (for publication) Protocol ARIISE track changes 5
Recruitment arrangements (for publication) ARIISE Subject recruitment procedure 2
Recruitment arrangements (for publication) Recruitment arrangements ARIISE track changes 2
Subject information and informed consent form (for publication) Deltagerinformation ARIISE 2
Subject information and informed consent form (for publication) Deltagerinformation ARIISE track changes 2
Subject information and informed consent form (for publication) Informeret samtykke ARIISE 1
Subject information and informed consent form (for publication) Tillg til samtykkeblanket - Retten til ikke-viden ARIISE 1
Summary of Product Characteristics (SmPC) (for publication) IB_ARIISE track changes 2
Summary of Product Characteristics (SmPC) (for publication) Product resume human albumin 1
Summary of Product Characteristics (SmPC) (for publication) Product resume natriumklorid 1

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-02-04 Denmark Acceptable with conditions
2025-05-01
 2025-12-08
2 SUBSTANTIAL MODIFICATION SM-1 2026-01-13 Denmark Acceptable
2026-01-30
 2026-01-30