Allogeneic Adipose Tissue-derived Stromal/Stem Cell Therapy in Patients With Ischemic Heart Disease and Heart Failure: A Phase II Danish Multicentre Study

JKastrup1 site in 1 country81 target enrollmentSeptember 2015

ConditionsHeart Failure

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Heart Failure
Sponsor: JKastrup
Enrollment: 81
Locations: 1
Primary Endpoint: change in left ventricle end-systolic volume (LVESV) from base line to 6 months follow-up measured by echocardiography and computerized tomography
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2015

End Date

July 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

JKastrup

Responsible Party

Sponsor Investigator

Principal Investigator

JKastrup

Professor Chief Physician

Rigshospitalet, Denmark

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
•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

Outcomes

Primary Outcomes

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

change in left ventricle end-systolic volume (LVESV) from base line to 6 months follow-up measured by echocardiography and computerized tomography

Secondary Outcomes

Efficacy clinical function assessed by change in 6 min walking test from baseline to 12 months follow-up(12 months)
Efficacy left ventricle(6 months)
Efficacy clinical function assessed by change in 6 min walking test from baseline to 6 months follow-up(6 months)
Efficacy clinical function assessed by change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 12 months follow-up(12 months)
Incidence of Treatment-Emergent Adverse Events(12 months)
Efficacy clinical function assessed by change in Seattle Angina Questionnaire and 6 min walking test from baseline to 6 months follow-up(6 months)
Efficacy clinical function assessed by change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 6 months follow-up(6 months)
Efficacy clinical function assessed by change in Seattle Angina Questionnaire and 6 min walking test from baseline to 12 months follow-up(12 months)