Stem Cell Therapy in IschEmic Non-treatable Cardiac Disease (SCIENCE)
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
CSCC_ASC
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, stem cell, adipose derived stem cell, Stem cell therapy, ischemic heart disease
Eligibility Criteria
Inclusion Criteria:
- 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)
- 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
Exclusion Criteria:
- 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.
- 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
Sites / Locations
- 2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
CSCC_ASC
Placebo
Arm Description
Cardiology Stem Cell Centre_adipose derived stem cells (CSCC_ASC)
Saline
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Safety - Serious adverse events
Incidence and severity of serious adverse events and suspected unrelated serious adverse events 12 months follow-up
Full Information
NCT ID
NCT02673164
First Posted
February 1, 2016
Last Updated
January 15, 2021
Sponsor
JKastrup
Collaborators
European Union
1. Study Identification
Unique Protocol Identification Number
NCT02673164
Brief Title
Stem Cell Therapy in IschEmic Non-treatable Cardiac Disease
Acronym
SCIENCE
Official Title
Stem Cell Therapy in IschEmic Non-treatable Cardiac Disease - SCIENCE A European Multi-Centre Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
JKastrup
Collaborators
European Union
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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) (≤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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, stem cell, adipose derived stem cell, Stem cell therapy, ischemic heart disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
133 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CSCC_ASC
Arm Type
Active Comparator
Arm Description
Cardiology Stem Cell Centre_adipose derived stem cells (CSCC_ASC)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline
Intervention Type
Biological
Intervention Name(s)
CSCC_ASC
Other Intervention Name(s)
Cardiology Stem Cell Centre_adipose derived stem cells
Intervention Description
The stem cells will be injected directly into the myocardium using the NOGA XP system (BDS, US)
Primary Outcome Measure Information:
Title
left ventricle end-systolic volume (LVESV)
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Safety - Serious adverse events
Description
Incidence and severity of serious adverse events and suspected unrelated serious adverse events 12 months follow-up
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
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
Exclusion Criteria:
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Kastrup, Professor MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data can be shared for Scientific collaboration
Learn more about this trial
Stem Cell Therapy in IschEmic Non-treatable Cardiac Disease
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