Retrograde Application of Bone Marrow Aspirate Concentrate

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Ostrava

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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