Retrograde Application of Bone Marrow Aspirate Concentrate
- Conditions
- Heart Failure
- Interventions
- Drug: BMAC
- Registration Number
- NCT03372954
- Lead Sponsor
- University Hospital Ostrava
- Brief Summary
The aim of our prospective randomised study is to assess the efficacy of the retrograde application of non-selected bone marrow autologous cells concentrate (BMAC) in patients with heart failure with reduced ejection fraction of left ventricle (HFREF) of ischemic aetiology. The evaluated preparation is concentrated BMAC, obtained using Harvest SmartPReP2 technology.
- Detailed Description
Our assumption is that non-selected BMAC administrations will lead to improvements in the left ventricular ejection fraction (LV EF), the left ventricular end-systolic and end-diastolic diameters and volumes (measured with magnetic resonance imaging) compared to standard heart failure therapy.
Furthermore, it will be associated with improved exercise tolerance in the six-minute corridor walk test and an improvement in the life quality of patients without increasing the incidence of severe ventricular arrythmias.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Patients with chronic heart failure and left ventricular ejection fraction ≤ 40% with coronary artery disease and with symptoms of heart failure in the NYHA class ≥ 3 on standard heart failure therapy for 3 months and in a stabilised state for at least 1 month
- Age ≥18 years
- Informed, written consent by the patient
- Ability to comply fully with the study protocol
- Negative pregnancy test (and effective contraception) in women with childbearing potential
- Previous bone marrow disease (especially myelodysplastic syndrome or non-Hodgkin's lymphoma)
- Acute myocardial infarction ˂ 1 week
- Active infection or antibiotics treatment ˂ 1 week
- Previous malingant ventricular arrhythmias without cardioverter-defibrilator (ICD) implantation
- Anemia (HTC≤28%), leukocythosis (≥ 14.000/mm3) or thrombocytopenia (≤50.000/mm3)
- Previous bleeding diathesis
- Need for hematopoietic growth factor treatment (e.g. erythropoetin, G-CSF)
- Impossibility of aspiration 240ml of bone marrow
- Hepathopathy or cirrhosis (bilirubin, ALT or AST ≥ 2,5x upper limit of normal)
- Terminal renal insufficiency or haemodyalysis
- Uncontrolled hypertension
- Need for high dose (> 7.5mg/day) corticotherapy within the next 6 months
- Inability to stop anticoagulation therapy (>72 hours) before bone marrow aspiration
- Known malignancies requiring actino or chemotherapy, or previous actinotherapy
- Patients with a BMI >40
- Known allergy to contrast agents
- Other comorbidities with a life expectancy of 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bone marrow autologous cells concentrate (BMAC) BMAC retrograde administration on non-selected BMAC via coronary sinus Control BMAC standard treatment o heart failure
- Primary Outcome Measures
Name Time Method Left ventricular end-systolic diameter (LVESd) 12 month Left ventricular end-systolic diameter
Left ventricular end-systolic volume (LVESV) 12 month Left ventricular end-systolic volume
Left ventricular end-diastolic diameter (LVEDd) 12 month Left ventricular end-diastolic diameter
ejection fraction of left ventricle (EF LV) 12 month ejection fraction of left ventricle
Left ventricular end-diastolic volume (LVEDV) 12 month Left ventricular end-diastolic volume
- Secondary Outcome Measures
Name Time Method corridor walk test 12 month walk distance in 6 min corridor walk test
QoL 12 month Quality of patients´ life using the Minnesota questionnaire
Trial Locations
- Locations (1)
University Hospital Ostrava
🇨🇿Ostrava-Poruba, Moravian-Silesian Region, Czechia