Ischemic heart failure MedDRA version: 20.0 Level: LLT Classification code 10019285 Term: Heart failure, unspecified System Organ Class: 100000004849
Conditions
Interventions
Product Name: CSCC_ASC
Pharmaceutical Form: Solution for injection/infusion
Other descriptive name: ALLOGENEIC ADIPOSE DERIVED STROMAL CELLS
Concentration unit: U unit(s)
Concentration type: equal
Con
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. 30 to 85 years of age 2. Written informed consent 3. Chronic stable ischemic heart disease 4. Symptomatic heart failure (NYHA II-III) 5. LVEF =40 % documented by echocardiography, CT or MRI obtained after up-titration of heart failure medication (if previously treated with cardiac resynchronisation at least 3 months after implantation) 6. Plasma NT-pro-BNP > 300 pg/ml (> 35 pmol/L) in sinus rhythm and plasma NT-pro-BNP > 422 pg/ml (> 49 pmol/L) in those patients with atrial fibrillation 7. Maximal tolerable heart failure medication 8. Heart failure medication unchanged two months prior to inclusion/signature of informed consent. Changes in diuretics are acceptable 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 and at least four months after the intervention to rule out early restenosis 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. NYHA I or IV heart failure 2. Implantation of a cardiac resynchronisation therapy device (CRT) within 3 months or Implantable Cardioverter Defibrillator (ICD) 1 month 3. Acute coronary syndrome with elevation of CKMB or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion 4. Other revascularisation treatment within four months of treatment 5. Moderate to severe aortic stenosis (valve area 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this trial is to investigate the treatment effect of repeat intra-myocardial injections of 100 million allogeneic CSCC_ASCs 6 months apart in patients with severe ischemic heart failure (=40%), in a randomized controlled study. ;Secondary Objective: Not applicable;Primary end point(s): The primary efficacy endpoint is change in left ventricle end-systolic volume (LVESV) at 12 months follow-up after first treatment. ;Timepoint(s) of evaluation of this end point: 12 months after (first) treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are changes in left ventricular ejection fraction (LVEF), end-systolic volume, end-diastolic volume and myocardial mass at 6 and 12 months follow-up. Other secondary endpoints are changes in NYHA, CCS, Kansas City Cardiomyopathy Questionnaire (KCCQ), Seattle Angina Questionnaire and EQ5D3L Questionnaire, 6 min walking test, additional echocardiographic measures and NT-pro-BNP. Moreover, secondary safety endpoint is evaluating development of allogeneic antibodies and laboratory safety measurements 3, 6 and 12 months after treatment. In addition, safety of allogeneic CSCC_ASCs with respect to incidence and severity of SAEs and suspected unrelated serious adverse events will be evaluated at 12 months follow-up. A combined endpoint of 1. death, hospitalization for worsening heart failure including inserting of a bi-ventricular pacemaker, hospitalization because of ventricular tachycardia or fibrillation and increased heart failure medical treatment 1, 2 and 3 years after treatment 2. death, hospitalization for any cardiovascular reason, hospitalization for worsening heart failure including inserting of a bi-ventricular pacemaker, hospitalization because of ventricular tachycardia or fibrillation and increased heart failure medical treatment 1, 2 and 3 years after treatment ;Timepoint(s) of evaluation of this end point: 6, 12, 24, 36 months after (first) treatment | — |
Countries
Denmark
Contacts
Public ContactAbbas Ali Qayyum
Rigshospitalet
Outcome results
None listed