The overall aim of the project is to test the feasibility and safety of allogeneic adipose-derived stromal cells (CSCC_ASC) investigational medicinal product, to improve myocardial function in patients with nonischemic dilated cardiomyopathies (NIDCM) and heart failure.
Conditions
Interventions
Product Name: CSCC_ASC - Allogeneic adipose tissue-derived stromal/stem cells
Product Code: CSCC_ASC
Pharmaceutical Form: Solution for injection/infusion
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 30 to 80 years of age 2. Signed informed consent 3. Patients with non-ischemic dilated cardiomyopathy 4. NYHA = II in spite of optimal heart failure treatment and have no other treatment options 5. Heart failure medication unchanged two months prior to inclusion/signature of informed consent. Changes in diuretics accepted 6. LVEF = 405% 7. Plasma NT-pro-BNP > 300 pg/ml (> 35 pmol/L) 8. Patients cannot be included until three months after implantation of a cardiac resynchronisation therapy device (CRTD) and until 1 month after an ICD unit Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Heart Failure NYHA I 2. Moderate to severe aortic stenosis (valve area 14 109/L) or thrombocytopenia (thrombocytes < 50 109/L) 10. Reduced kidney function (eGFR < 30 ml/min) 11. Left ventricular thrombus 12. Anticoagulation treatment that cannot be paused during cell injections. 13. Patients with reduced immune response 14. History with malignant disease within five years of inclusion or suspected malignity – except treated skin cancer other than melanoma 15. Pregnant women 16. Woman of childbearing potential unless ßHCG negative and they should be on contraception during the trial 17. Other experimental treatment within four weeks of baseline tests 18. Participation in another intervention trial 19. Life expectancy less than one year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to investigate safety and regenerative capacity of direct intra-myocardial injection of 100 million allogeneic CSCC_ASCs in NIDCM patients with reduced left ventricular EF (= 40%) and heart failure.;Secondary Objective: Allogeneic antibodies, left ventricular ejection fraction, end-systolic volume and myocardial mass. Development of allogeneic antibodies and laboratory safety measurements 1, 3 and 6 months after treatment and changes in left ventricular ejection fraction (LVEF), end-diastolic volume and myocardial mass at 6 months follow-up. Additional secondary endpoints are changes in NYHA, Kansas City Cardiomyopathy Questionnaire, EQ-5D3L Questionnaire, 6 min walking test, additional echocardiographic measures (Global strain %) and NT-pro-BNP.;Primary end point(s): 1. Left ventricle end-systolic volume Measured using echocardiography;Timepoint(s) of evaluation of this end point: 6 months after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Allogeneic antibodies, left ventricular ejection fraction, end-systolic volume and myocardial mass. Additional secondary endpoints are changes in NYHA, Kansas City Cardiomyopathy Questionnaire, EQ-5D3L Questionnaire, 6 min walking test, additional echocardiographic measures (Global strain %) and NTpro-BNP. ;Timepoint(s) of evaluation of this end point: 1, 3, 6 and 12 months after treatment | — |
Countries
Slovenia
Contacts
Public ContactDepartment of Cardiology
Rigshospitalet
Outcome results
None listed