Retrograde Application of Bone Marrow Aspirate Concentrate

University Hospital Ostrava

Status and phase: Completed; Phase 2

Conditions: Heart Failure

Treatments: Drug: BMAC

Study type: Interventional

Funder types: Other

Identifiers

NCT03372954

FNO-Retro

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Bone marrow autologous cells concentrate (BMAC)

Experimental group

Description:

retrograde administration on non-selected BMAC via coronary sinus

Treatment:

Drug: BMAC

Control

Placebo Comparator group

Description:

standard treatment o heart failure

Treatment:

Drug: BMAC