Non-Ischemic Heart FailurePhase 2ARIISENCT06840275
ASCs in Recently Diagnosed Non-ischemic Heart Failure
A Phase 2 study testing Allogeneic adipose tissue-derived mesenchymal stem cells and Cryostor CS10 in people with Non-Ischemic Heart Failure and Reduced Ejection Fraction Heart Failure, run by Cell to Cure ApS at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non-Ischemic Heart Failure, Reduced Ejection Fraction Heart Failure
- What is being tested?
- Allogeneic adipose tissue-derived mesenchymal stem cells and Cryostor CS10
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2026to 1 Sep 2028
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Cardiology Stem Cell Centre, Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Denmark
Copenhagen, 2100
About this study
Official title: 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
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.
Read the 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.
- Being tested
- Allogeneic adipose tissue-derived mesenchymal stem cells, Cryostor CS10
- Keywords
- allogeneic adipose tissue derived mesenchymal stromal cell, non-ischemic heart failure, mesenchymal stromal cell
- Medical subject headings
- Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic adipose tissue-derived mesenchymal stem cellsDrug
Also called C2C_ASC110
Two intravenous infusions of C2C_ASC110 1 month apart. The C2C_ASC110 product contains 110 million cells.
Cryostor CS10Other
Two intravenous infusions of CryoStor CS10 1 month apart.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Allogeneic adipose tissue-derived mesenchymal stem cells |
| CryoStor® CS10 | Placebo comparator | Intravenous infusion of CryoStor® CS10 1 month apart. Receives: Other: Cryostor CS10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 6 months after the last infusion of C2C_ASC110 and placebo.
Secondary outcomes (9)
Changes in left ventricular end systolic volume
Changes in left ventricular end systolic volume
Measured: From enrollment to 7 months and to 12 months.
Change in left ventricular ejection fraction (II)
Change in left ventricular ejection fraction.
Measured: From enrollment to 7 months and to 12 months.
Changes in left ventricular end diastolic volume
Changes in left ventricular end diastolic volume.
Measured: From enrollment to 7 months and to 12 months.
Change in NYHA classification
Change in New York Heart Association (NYHA) classification. A scale from 1 to 4 describing the extent of heart failure by patient-reported symptoms, with class 1 denoting no symptoms and no limitations in ordinary physical activity and class 4 denoting symptoms and severe limitations in ordinary physical activity.
Measured: From enrollment to 12 months.
Change in KCCQ questionnaire score
Change in Kansas City Cardiomyopathy (KCCQ) questionnaire score. A scale from 0 to 100 describing health status in patients with heart failure, with 0 denoting the worst possible health status and 100 denotes the best possible health status.
Measured: From enrollment to 12 months.
Change in EQ5D5L questionnaire score
Change in European Quality of Life - 5 Dimensions (EQ5D5L) questionnaire score. A scale from 0 to 100 describing health related quality of life, with 0 denoting the worst possible quality of life and 100 denoting the best possible quality of life.
Measured: From enrollment to 12 months.
Change in 6 minutes walking test
Change in 6 minutes walking test.
Measured: From enrollment to 12 months.
Change in Pro-BNP
Change in Pro-BNP.
Measured: From enrollment to 12 months.
Incidence and severity of adverse reactions
Incidence and severity of serious adverse reactions and suspected unexpected serious adverse reactions.
Measured: From the first infusion of C2C_ASC110 and placebo to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Mar 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Why it stopped: Due to changes in company structure and investment the trial will not be initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Ischemic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cell to Cure ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abbas A Qayyum, MD MSc PhD, Principal investigator, Cardiology Stem Cell Centre, Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840275
- Sponsor's protocol ID
- ARIISE
- Other IDs
- 2025-520837-22-00, U1111-1315-7011, 2025
- Acronym
- ARIISE
- Status last verified
- Mar 2026
- First submitted
- 3 Feb 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 Apr;22(4):353-361. doi: 10.1080/14796678.2026.2647879. Epub 2026 Mar 25.
PubMed 41879383
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06840275
- Acronym / sponsor ID
- ARIISE / ARIISE
- Keywords
- allogeneic adipose tissue derived mesenchymal stromal cell, non-ischemic heart failure, mesenchymal stromal cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to changes in company structure and investment the trial will not be initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cell to Cure ApSIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allogeneic adipose tissue-derived mesenchymal stromal cells (C2C_ASC110) | Experimental | Drug: Allogeneic adipose tissue-derived mesenchymal stem cellsIntravenous infusion of allogeneic adipose tissue-derived mesenchymal stromal cells (C2C_ASC110) 1 month apart. |
| CryoStor® CS10 | Placebo comparator | Other: Cryostor CS10Intravenous infusion of CryoStor® CS10 1 month apart. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic adipose tissue-derived mesenchymal stem cellsAlso: C2C_ASC110Two intravenous infusions of C2C_ASC110 1 month apart. The C2C_ASC110 product contains 110 million cells. | Drug | Allogeneic adipose tissue-derived mesenchymal stromal cells (C2C_ASC110) |
| Cryostor CS10Two intravenous infusions of CryoStor CS10 1 month apart. | Other | CryoStor® CS10 |
Primary outcome
Change in left ventricular ejection fraction (I)
Time frame: From enrollment to 6 months after the last infusion of C2C_ASC110 and placebo.
Change in left ventricular ejection fraction 6 months after last C2C_ASC110 infusion compared to the placebo group.
9 secondary outcomes
Changes in left ventricular end systolic volume
Time frame: From enrollment to 7 months and to 12 months.
Change in left ventricular ejection fraction (II)
Time frame: From enrollment to 7 months and to 12 months.
Changes in left ventricular end diastolic volume
Time frame: From enrollment to 7 months and to 12 months.
Change in NYHA classification
Time frame: From enrollment to 12 months.
Change in KCCQ questionnaire score
Time frame: From enrollment to 12 months.
Change in EQ5D5L questionnaire score
Time frame: From enrollment to 12 months.
Change in 6 minutes walking test
Time frame: From enrollment to 12 months.
Change in Pro-BNP
Time frame: From enrollment to 12 months.
Incidence and severity of adverse reactions
Time frame: From the first infusion of C2C_ASC110 and placebo to 12 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Derived from this study: PubMed 41879383Chaaban 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 Apr;22(4):353-361. doi: 10.1080/14796678.2026.2647879. Epub 2026 Mar 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abbas A Qayyum, MD MSc PhD principal investigator
Cardiology Stem Cell Centre, Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allogeneic adipose tissue-derived mesenchymal stem cells and Cryostor CS10 in people with Non-Ischemic Heart Failure and Reduced Ejection Fraction Heart Failure, run by Cell to Cure ApS at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in left ventricular ejection fraction (I) (time frame: From enrollment to 6 months after the last infusion of C2C_ASC110 and placebo.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06840275, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.