Back to resultsAllogeneic Stem Cell Therapy in Heart Failure (CSCC_ASCII)
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Cardiology Stem Cell Centre Adipose Stem Cell (CSCC_ASC)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
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%
- 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
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Cardiology Stem Cell Centre Adipose Stem Cell (CSCC_ASC)
Placebo
Arm Description
Allogeneic adipose derived stromal cells
Saline
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Efficacy left ventricle
change in left ventricle ejection fraction (EF) measured by echocardiography and computerized tomography
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
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
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03092284
Brief Title
Allogeneic Stem Cell Therapy in Heart Failure
Acronym
CSCC_ASCII
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
July 2021 (Actual)
Study Completion Date
July 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
JKastrup
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cardiology Stem Cell Centre Adipose Stem Cell (CSCC_ASC)
Arm Type
Active Comparator
Arm Description
Allogeneic adipose derived stromal cells
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline
Intervention Type
Biological
Intervention Name(s)
Cardiology Stem Cell Centre Adipose Stem Cell (CSCC_ASC)
Intervention Description
Direct intramyocardial injection of CSCC_ASC
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Saline
Primary Outcome Measure Information:
Title
change in left ventricle end-systolic volume (LVESV) from base line to 6 months follow-up measured by echocardiography and computerized tomography
Description
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
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
Safety is evaluated by the incidence and severity of serious adverse events and suspected unrelated serious adverse events at 12 months follow-up
Time Frame
12 months
Title
Efficacy left ventricle
Description
change in left ventricle ejection fraction (EF) measured by echocardiography and computerized tomography
Time Frame
6 months
Title
Efficacy clinical function assessed by change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 6 months follow-up
Description
change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 6 months follow-up
Time Frame
6 months
Title
Efficacy clinical function assessed by change in Seattle Angina Questionnaire and 6 min walking test from baseline to 6 months follow-up
Description
change in Seattle Angina Questionnaire and 6 min walking test from baseline to 6 months follow-up
Time Frame
6 months
Title
Efficacy clinical function assessed by change in 6 min walking test from baseline to 6 months follow-up
Description
change in 6 min walking test from baseline to 6 months follow-up
Time Frame
6 months
Title
Efficacy clinical function assessed by change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 12 months follow-up
Description
change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 12 months follow-up
Time Frame
12 months
Title
Efficacy clinical function assessed by change in Seattle Angina Questionnaire and 6 min walking test from baseline to 12 months follow-up
Description
change in Seattle Angina Questionnaire and 6 min walking test from baseline to 12 months follow-up
Time Frame
12 months
Title
Efficacy clinical function assessed by change in 6 min walking test from baseline to 12 months follow-up
Description
change in 6 min walking test from baseline to 12 months follow-up
Time Frame
12 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%
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
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Kastrup, Professor MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet
City
Copenhagen Ø
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data can be share for scientific collaboration
Learn more about this trial
Allogeneic Stem Cell Therapy in Heart Failure
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