Retrograde Application of Bone Marrow Aspirate Concentrate (Retro)
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 2
Locations
Czechia
Study Type
Interventional
Intervention
BMAC
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
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
Sites / Locations
- University Hospital Ostrava
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bone marrow autologous cells concentrate (BMAC)
Control
Arm Description
retrograde administration on non-selected BMAC via coronary sinus
standard treatment o heart failure
Outcomes
Primary Outcome Measures
Left ventricular end-systolic diameter (LVESd)
Left ventricular end-systolic diameter
Left ventricular end-systolic volume (LVESV)
Left ventricular end-systolic volume
Left ventricular end-diastolic diameter (LVEDd)
Left ventricular end-diastolic diameter
Left ventricular end-diastolic volume (LVEDV)
Left ventricular end-diastolic volume
ejection fraction of left ventricle (EF LV)
ejection fraction of left ventricle
Secondary Outcome Measures
corridor walk test
walk distance in 6 min corridor walk test
QoL
Quality of patients´ life using the Minnesota questionnaire
Full Information
NCT ID
NCT03372954
First Posted
December 10, 2017
Last Updated
December 6, 2022
Sponsor
University Hospital Ostrava
1. Study Identification
Unique Protocol Identification Number
NCT03372954
Brief Title
Retrograde Application of Bone Marrow Aspirate Concentrate
Acronym
Retro
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bone marrow autologous cells concentrate (BMAC)
Arm Type
Experimental
Arm Description
retrograde administration on non-selected BMAC via coronary sinus
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
standard treatment o heart failure
Intervention Type
Drug
Intervention Name(s)
BMAC
Intervention Description
retrograde administration on non-selected BMAC via coronary sinus
Primary Outcome Measure Information:
Title
Left ventricular end-systolic diameter (LVESd)
Description
Left ventricular end-systolic diameter
Time Frame
12 month
Title
Left ventricular end-systolic volume (LVESV)
Description
Left ventricular end-systolic volume
Time Frame
12 month
Title
Left ventricular end-diastolic diameter (LVEDd)
Description
Left ventricular end-diastolic diameter
Time Frame
12 month
Title
Left ventricular end-diastolic volume (LVEDV)
Description
Left ventricular end-diastolic volume
Time Frame
12 month
Title
ejection fraction of left ventricle (EF LV)
Description
ejection fraction of left ventricle
Time Frame
12 month
Secondary Outcome Measure Information:
Title
corridor walk test
Description
walk distance in 6 min corridor walk test
Time Frame
12 month
Title
QoL
Description
Quality of patients´ life using the Minnesota questionnaire
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leoš Pleva, MD,PhD
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava-Poruba
State/Province
Moravian-Silesian Region
ZIP/Postal Code
708 52
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There exists no plan to make individual participant data available to other researchers. The data may be provided upon request.
Citations:
PubMed Identifier
30704414
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.
Results Reference
derived
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Retrograde Application of Bone Marrow Aspirate Concentrate
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