Status:
COMPLETED
Retrograde Application of Bone Marrow Aspirate Concentrate
Lead Sponsor:
University Hospital Ostrava
Conditions:
Heart Failure
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03372954
Start Date
January 1 2018
End Date
December 31 2021
Last Update
December 9 2022
Active Locations (1)
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1
University Hospital Ostrava
Ostrava-Poruba, Moravian-Silesian Region, Czechia, 708 52