Clinical trial NCT03092284: Allogeneic Stem Cell Therapy in Heart Failure
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 81
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 30 to 80 years of age
2. Signed informed consent
3. Chronic stable ischemic heart disease
4. Symptomatic heart failure - New York Heart Association (NYHA) class II-III
5. EF ≤45%
6. 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
7. Maximal tolerable heart failure medication
8. Medication unchanged two months prior to inclusion
9. No option for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
10. 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
11. Patients cannot be included until three months after implantation of a cardiac resynchronisation therapy device

Exclusion Criteria:

1. Heart Failure (NYHA I or IV)
2. Acute coronary syndrome with elevation of creatine kinase (CK) isoenzyme MB (CKMB) or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion
3. Other revascularisation treatment within four months of treatment
4. If clinically indicated the patient should have a coronary angiography before inclusion
5. Moderate to severe aortic stenosis (valve area \< 1.3 mm2) or valvular disease with option for surgery.
6. 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
7. Clinical significant anaemia (haemoglobin \< 6 mmol/L), leukopenia (leucocytes \< 2 109/L), leucocytosis (leucocytes \>14 109/L) or thrombocytopenia (thrombocytes \< 50 109/L)
8. Anticoagulation treatment that cannot be paused during cell injections
9. Patients with reduced immune response
10. History with malignant disease within five years of inclusion or suspected malignity - except treated skin cancer other than melanoma
11. Pregnant women
12. Other experimental treatment within four weeks of baseline tests
13. Participation in another intervention trial

Primary outcomes:
measure: change in left ventricle end-systolic volume (LVESV) from base line to 6 months follow-up measured by echocardiography and computerized tomography
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 12 months
measure: Efficacy left ventricle
timeFrame: 6 months
measure: Efficacy clinical function assessed by change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 6 months follow-up
timeFrame: 6 months
measure: Efficacy clinical function assessed by change in Seattle Angina Questionnaire and 6 min walking test from baseline to 6 months follow-up
timeFrame: 6 months
measure: Efficacy clinical function assessed by change in 6 min walking test from baseline to 6 months follow-up
timeFrame: 6 months
measure: Efficacy clinical function assessed by change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 12 months follow-up
timeFrame: 12 months
measure: Efficacy clinical function assessed by change in Seattle Angina Questionnaire and 6 min walking test from baseline to 12 months follow-up
timeFrame: 12 months
measure: Efficacy clinical function assessed by change in 6 min walking test from baseline to 12 months follow-up
timeFrame: 12 months
Other outcomes:
Locations:
city: Copenhagen Ø
country: Denmark
facility: Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Jens Kastrup, Professor MD
role: STUDY_DIRECTOR
References: