Clinical trial NCT03372954: Retrograde Application of Bone Marrow Aspirate Concentrate
Official title: Retrograde Application of Bone Marrow Aspirate Concentrate (BMAC) Through Coronary Sinus in Patients With Congestive Heart Failure of Ischemic Etiology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Left ventricular end-systolic diameter (LVESd)
timeFrame: 12 month
measure: Left ventricular end-systolic volume (LVESV)
timeFrame: 12 month
measure: Left ventricular end-diastolic diameter (LVEDd)
timeFrame: 12 month
measure: Left ventricular end-diastolic volume (LVEDV)
timeFrame: 12 month
measure: ejection fraction of left ventricle (EF LV)
timeFrame: 12 month
Secondary outcomes:
measure: corridor walk test
timeFrame: 12 month
measure: QoL
timeFrame: 12 month
Other outcomes:
Locations:
city: Ostrava-Poruba
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Leoš Pleva, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pleva L, Kukla P, Vitkova K, Prochazka V. Rationale and design of a prospective, randomised study of retrograde application of bone marrow aspirate concentrate (BMAC) through coronary sinus in patients with congestive heart failure of ischemic etiology (the RETRO study). BMC Cardiovasc Disord. 2019 Jan 31;19(1):32. doi: 10.1186/s12872-019-1011-9.