Heart FailurePhase 2SCIENCENCT02673164
Stem Cell Therapy in IschEmic Non-treatable Cardiac Disease
A Phase 2 study testing CSCC_ASC in people with Heart Failure, run by JKastrup at 1 site in Denmark.
Trial summary
The aim of the SCIENCE study is, in an international multicentre double-blind placebo-controlled study, to investigate efficacy of direct intra-myocardial injection of 100 mio. allogeneic Cardiology Stem Cell Centre_adipose derived stem cells (CSCC_ASCs) in patients with reduced left ventricular Ejection Fraction (EF)… 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?
- CSCC_ASC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2017to Dec 2020
- 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% on echocardiography, Computerized Tomography (CT) or Magnetic Resonances Imaging (MRI) scan
- Plasma NT-pro-BNP > 300 pg/ml (> 35 pmol/L)
Show all 11Show fewer
- Maximal tolerable heart failure medication
- Heart failure medication unchanged two months prior to inclusion. Changes in diuretics accepted.
- 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 coronary 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 (CRTD) and until 1 month after an ICD unit
Who cannot join
- Heart Failure (NYHA class I or IV)
- Acute coronary syndrome with acute reversible elevation of CKMB or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion. Constant elevated troponin due to renal failure, heart failure etc. do not exclude the patient.
- 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 cm2) or valvular disease with option for surgery or interventional therapy.
- Aortic valve replacement with an artificial heart valve. However, a trans-septal treatment approach can be considered in these patients.
Show all 19Show fewer
- If the patient is expected to be candidate for MitraClip therapy of mitral regurgitation in the 12 months follow-up period.
- 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
- Clinical significant anaemia (haemoglobin < 6 mmol/L), leukopenia (leucocytes < 2 109/L), leucocytosis (leucocytes > 14 109/L) or thrombocytopenia (thrombocytes < 50 109/L)
- Reduced kidney function (estimated Glomerular Filtration Rate (eGFR) < 30 ml/min)
- Left ventricular thrombus
- Anticoagulation treatment that cannot be paused during cell injections. Patients can continue with platelet inhibitor treatment
- Patients with reduced immune response or known anti-HLA (human leukocyte antigen) antibodies
- 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
- Life expectancy less than one year
- Known hypersensitivity to Dimethyl sulfoxide (DMSO), penicillin and streptomycin
Trial locations and contacts
1 site in 1 country.
Denmark1 site
2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet
Copenhagen, 2100
About this study
Official title: Stem Cell Therapy in IschEmic Non-treatable Cardiac Disease - SCIENCE A European Multi-Centre Trial
The aim of the SCIENCE study is, in an international multicentre double-blind placebo-controlled study, to investigate efficacy of direct intra-myocardial injection of 100 mio. allogeneic Cardiology Stem Cell Centre_adipose derived stem cells (CSCC_ASCs) in patients with reduced left ventricular Ejection Fraction (EF) (≤45%) and heart failure.
Read the detailed description
The aim of the SCIENCE study is, in an international multicentre double-blind placebo-controlled study, to investigate efficacy of direct intra-myocardial injection of 100 mio. allogeneic Cardiology Stem Cell Centre_adipose derived stem cells (CSCC_ASCs) in patients with reduced left ventricular EF (≤45%) and heart failure.
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 EF (≤45%) and heart failure in a double-blind placebo-controlled design.
A total of 138 patients with will be enrolled in the study and treated in a 2:1 randomization with either CSCC_ASC or placebo (saline).
- Conditions
- Heart Failure
- Being tested
- CSCC_ASC
- Keywords
- Heart failure, stem cell, adipose derived stem cell, Stem cell therapy, ischemic heart disease
- Medical subject headings
- Heart Failure, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSCC_ASCBiological
Also called Cardiology Stem Cell Centre_adipose derived stem cells
The stem cells will be injected directly into the myocardium using the NOGA XP system (BDS, US)
| Study group | Role | What they receive |
|---|---|---|
| CSCC_ASC | Active comparator | Cardiology Stem Cell Centre_adipose derived stem cells (CSCC_ASC) Receives: Biological: CSCC_ASC |
| Placebo | Placebo comparator | Saline Receives: Biological: CSCC_ASC |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricle end-systolic volume (LVESV)
The primary endpoint is change in left ventricle end-systolic volume (LVESV) from baseline to 6 months follow-up measured by ECHO, MR and CT between CSCC_ASC and placebo treated
Measured: 6 months
Secondary outcomes (1)
Safety - Serious adverse events
Incidence and severity of serious adverse events and suspected unrelated serious adverse events 12 months follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- JKastrup
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Sponsor-investigator, JKastrup, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Jens Kastrup, Professor MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673164
- Sponsor's protocol ID
- SCIENCE
- Acronym
- SCIENCE
- Status last verified
- Jan 2021
- First submitted
- 1 Feb 2016
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data can be shared for Scientific collaboration
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stem Cell Therapy in IschEmic Non-treatable Cardiac Disease - SCIENCE A European Multi-Centre Trial
- ClinicalTrials.gov ID
- NCT02673164
- Acronym / sponsor ID
- SCIENCE / SCIENCE
- Conditions
- Heart Failure
- Keywords
- Heart failure, stem cell, adipose derived stem cell, Stem cell therapy, ischemic heart disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- JKastrupUniversity, hospital or other
- Collaborators
- European Union
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 3 Feb 2016 (estimated)
- 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 aim of the SCIENCE study is, in an international multicentre double-blind placebo-controlled study, to investigate efficacy of direct intra-myocardial injection of 100 mio. allogeneic Cardiology Stem Cell Centre_adipose derived stem cells (CSCC_ASCs) in patients with reduced left ventricular Ejection Fraction (EF) (≤45%) and heart failure.
Detailed description
The aim of the SCIENCE study is, in an international multicentre double-blind placebo-controlled study, to investigate efficacy of direct intra-myocardial injection of 100 mio. allogeneic Cardiology Stem Cell Centre_adipose derived stem cells (CSCC_ASCs) in patients with reduced left ventricular EF (≤45%) and heart failure.
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 EF (≤45%) and heart failure in a double-blind placebo-controlled design.
A total of 138 patients with will be enrolled in the study and treated in a 2:1 randomization with either CSCC_ASC or placebo (saline).
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 |
|---|---|---|
| CSCC_ASC | Active comparator | Biological: CSCC_ASCCardiology Stem Cell Centre_adipose derived stem cells (CSCC_ASC) |
| Placebo | Placebo comparator | Biological: CSCC_ASCSaline |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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% on echocardiography, Computerized Tomography (CT) or Magnetic Resonances Imaging (MRI) scan
Key exclusion criteria (19 listed)
- Heart Failure (NYHA class I or IV)
- Acute coronary syndrome with acute reversible elevation of CKMB or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion. Constant elevated troponin due to renal failure, heart failure etc. do not exclude the patient.
- 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 cm2) or valvular disease with option for surgery or interventional therapy.
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 |
|---|---|---|
| CSCC_ASCAlso: Cardiology Stem Cell Centre_adipose derived stem cellsThe stem cells will be injected directly into the myocardium using the NOGA XP system (BDS, US) | Biological | CSCC_ASC, Placebo |
Primary outcome
left ventricle end-systolic volume (LVESV)
Time frame: 6 months
The primary endpoint is change in left ventricle end-systolic volume (LVESV) from baseline to 6 months follow-up measured by ECHO, MR and CT between CSCC_ASC and placebo treated
1 secondary outcome
Safety - Serious adverse events
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Individual participant dataSharing planned: Yes. Data can be shared for Scientific collaboration
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Jens Kastrup, Professor MD principal investigator
Copenhagen University Hospital, Rigshospitalet
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 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 19 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 19 Jan 2021. 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?
left ventricle end-systolic volume (LVESV) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2021; AzTrials last refreshed its copy on 6 Nov 2026.