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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
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
December 10, 2017
Last Updated
December 6, 2022
Sponsor
University Hospital Ostrava
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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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