CSCC_ASCII: Allogeneic Stem Cell Therapy in Heart Failure
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Cardiology Stem Cell Centre Adipose Stem Cell (CSCC_ASC) Allogeneic adipose derived stromal cells |
Biological: Cardiology Stem Cell Centre Adipose Stem Cell (CSCC_ASC)
Direct intramyocardial injection of CSCC_ASC
|
| Placebo Comparator: Placebo Saline |
Biological: Placebo
Saline
|
Outcome Measures
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 [6 months]
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 [12 months]
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 [6 months]
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 [6 months]
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 [6 months]
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 [6 months]
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 [12 months]
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 [12 months]
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 [12 months]
change in 6 min walking test from baseline to 12 months follow-up
Eligibility Criteria
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
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Other revascularisation treatment within four months of treatment
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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
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Patients with reduced immune response
-
History with malignant disease within five years of inclusion or suspected malignity - except treated skin cancer other than melanoma
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Pregnant women
-
Other experimental treatment within four weeks of baseline tests
-
Participation in another intervention trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet | Copenhagen Ø | Denmark | 2100 |
Sponsors and Collaborators
- JKastrup
Investigators
- Study Director: Jens Kastrup, Professor MD, Rigshospitalet, Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CSCC_ASCII