Retrograde Application of Bone Marrow Aspirate Concentrate

Heart Failure Clinical Trial

— Retro  

Official title:

Retrograde Application of Bone Marrow Aspirate Concentrate (BMAC) Through Coronary Sinus in Patients With Congestive Heart Failure of Ischemic Etiology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03372954
• Other study ID #: FNO-Retro
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2022
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• BMAC
retrograde administration on non-selected BMAC via coronary sinus

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava-Poruba	Moravian-Silesian Region

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular end-systolic diameter (LVESd)	Left ventricular end-systolic diameter	12 month
Primary	Left ventricular end-systolic volume (LVESV)	Left ventricular end-systolic volume	12 month
Primary	Left ventricular end-diastolic diameter (LVEDd)	Left ventricular end-diastolic diameter	12 month
Primary	Left ventricular end-diastolic volume (LVEDV)	Left ventricular end-diastolic volume	12 month
Primary	ejection fraction of left ventricle (EF LV)	ejection fraction of left ventricle	12 month
Secondary	corridor walk test	walk distance in 6 min corridor walk test	12 month
Secondary	QoL	Quality of patients´ life using the Minnesota questionnaire	12 month