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Heart FailurePhase 2CSCC_ASCIINCT03092284

Allogeneic Stem Cell Therapy in Heart Failure

A Phase 2 study testing Cardiology Stem Cell Centre Adipose Stem Cell (CSCC_ASC) in people with Heart Failure, run by JKastrup at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The present aim is to perform at clinical double-blind placebo-controlled Cardiology Stem Cell Centre - Adipose Stem Cells (CSCC_ASC) study in heart failure patients to investigate the regenerative capacity of the CSCC_ASC treatment. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Heart Failure
What is being tested?
Cardiology Stem Cell Centre Adipose Stem Cell (CSCC_ASC)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
81 participants
Where
1 siteDenmark
Study dates
Sep 2015to Jul 2022
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 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 30 to 80 years of age
  • Signed informed consent
  • Chronic stable ischemic heart disease
  • Symptomatic heart failure - New York Heart Association (NYHA) class II-III
  • EF ≤45%
  • Plasma NT-pro-BNP > 300 pg/ml (> 35 pmol/L) in sinus rhythm and plasma NT-pro-BNP > 422 pg/ml (> 450 pmol/L) in patients with atrial fibrillation
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  • Maximal tolerable heart failure medication
  • Medication unchanged two months prior to inclusion
  • No option for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
  • Patients who have had PCI or CABG within six months of inclusion must have a new angiography less than one month before inclusion or at least four months after the intervention to rule out early restenosis
  • Patients cannot be included until three months after implantation of a cardiac resynchronisation therapy device

Who cannot join

  • Heart Failure (NYHA I or IV)
  • Acute coronary syndrome with elevation of creatine kinase (CK) isoenzyme MB (CKMB) or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion
  • Other revascularisation treatment within four months of treatment
  • If clinically indicated the patient should have a coronary angiography before inclusion
  • Moderate to severe aortic stenosis (valve area < 1.3 mm2) or valvular disease with option for surgery.
  • Diminished functional capacity for other reasons such as: obstructive pulmonary disease (COPD) with forced expiratory volume (FEV) <1 L/min, moderate to severe claudication or morbid obesity
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  • Clinical significant anaemia (haemoglobin < 6 mmol/L), leukopenia (leucocytes < 2 109/L), leucocytosis (leucocytes >14 109/L) or thrombocytopenia (thrombocytes < 50 109/L)
  • Anticoagulation treatment that cannot be paused during cell injections
  • Patients with reduced immune response
  • History with malignant disease within five years of inclusion or suspected malignity - except treated skin cancer other than melanoma
  • Pregnant women
  • Other experimental treatment within four weeks of baseline tests
  • Participation in another intervention trial

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet

    Copenhagen Ø, 2100

Other trials in Denmark

About this study

Official title: Allogeneic Adipose Tissue-derived Stromal/Stem Cell Therapy in Patients With Ischemic Heart Disease and Heart Failure: A Phase II Danish Multicentre Study

The present aim is to perform at clinical double-blind placebo-controlled Cardiology Stem Cell Centre - Adipose Stem Cells (CSCC_ASC) study in heart failure patients to investigate the regenerative capacity of the CSCC_ASC treatment.

Read the detailed description

The primary objective is to investigate the regenerative capacity of direct intra-myocardial injection of 100 mio. allogeneic CSCC_ASCs in patients with reduced left ventricular Ejection Fraction (EF) (≤45%) and heart failure in a double-blind placebo-controlled design.

A total of 81 patients with will be enrolled in the study and treated in a 2:1 randomization with either CSCC_ASC or placebo (saline).

The primary endpoint is change in left ventricle end-systolic volume (LVESV) at 6 months follow-up.

Conditions
Heart Failure
Being tested
Cardiology Stem Cell Centre Adipose Stem Cell (CSCC_ASC), Placebo
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiology Stem Cell Centre Adipose Stem Cell (CSCC_ASC)Biological

    Direct intramyocardial injection of CSCC_ASC

  • PlaceboBiological

    Saline

Study groups in NCT03092284
Study groupRoleWhat they receive
Cardiology Stem Cell Centre Adipose Stem Cell (CSCC_ASC)Active comparatorAllogeneic adipose derived stromal cells
Receives: Biological: Cardiology Stem Cell Centre Adipose Stem Cell (CSCC_ASC)
PlaceboPlacebo comparatorSaline
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in left ventricle end-systolic volume (LVESV) from base line to 6 months follow-up measured by echocardiography and computerized tomography

    change in left ventricle end-systolic volume (LVESV) from base line to 6 months follow-up measured by echocardiography and computerized tomography

    Measured: 6 months

Secondary outcomes (8)

  1. Incidence of Treatment-Emergent Adverse Events

    Safety is evaluated by the incidence and severity of serious adverse events and suspected unrelated serious adverse events at 12 months follow-up

    Measured: 12 months

  2. Efficacy left ventricle

    change in left ventricle ejection fraction (EF) measured by echocardiography and computerized tomography

    Measured: 6 months

  3. Efficacy clinical function assessed by change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 6 months follow-up

    change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 6 months follow-up

    Measured: 6 months

  4. Efficacy clinical function assessed by change in Seattle Angina Questionnaire and 6 min walking test from baseline to 6 months follow-up

    change in Seattle Angina Questionnaire and 6 min walking test from baseline to 6 months follow-up

    Measured: 6 months

  5. Efficacy clinical function assessed by change in 6 min walking test from baseline to 6 months follow-up

    change in 6 min walking test from baseline to 6 months follow-up

    Measured: 6 months

  6. Efficacy clinical function assessed by change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 12 months follow-up

    change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 12 months follow-up

    Measured: 12 months

  7. Efficacy clinical function assessed by change in Seattle Angina Questionnaire and 6 min walking test from baseline to 12 months follow-up

    change in Seattle Angina Questionnaire and 6 min walking test from baseline to 12 months follow-up

    Measured: 12 months

  8. Efficacy clinical function assessed by change in 6 min walking test from baseline to 12 months follow-up

    change in 6 min walking test from baseline to 12 months follow-up

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2017
  2. Study startSep 2015
  3. Primary completionJul 2021
  4. Study completionJul 2022

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03092284
Sponsor's protocol ID
CSCC_ASCII
Acronym
CSCC_ASCII
Status last verified
Sep 2022
First submitted
20 Jul 2015
Last updated
6 Sep 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Data can be share for scientific collaboration

Publications

  • Qayyum AA, Mouridsen M, Nilsson B, Gustafsson I, Schou M, Nielsen OW, Hove JD, Mathiasen AB, Jorgensen E, Helqvist S, Joshi FR, Johansen EM, Follin B, Juhl M, Hojgaard LD, Haack-Sorensen M, Ekblond A, Kastrup J. Danish phase II trial using adipose tissue derived mesenchymal stromal cells for patients with ischaemic heart failure. ESC Heart Fail. 2023 Apr;10(2):1170-1183. doi: 10.1002/ehf2.14281. Epub 2023 Jan 13.

    PubMed 36638837

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cardiology Stem Cell Centre Adipose Stem Cell (CSCC_ASC) in people with Heart Failure, run by JKastrup 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 11 inclusion and 13 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: finished, as of the sponsor's last update on 6 Sep 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 ventricle end-systolic volume (LVESV) from base line to 6 months follow-up measured by echocardiography and computerized tomography (time frame: 6 months). 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 NCT03092284, 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 6 Sep 2022.

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