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Retrograde Application of Bone Marrow Aspirate Concentrate (Retro)

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ClinicalTrials.gov Identifier: NCT03372954
Recruitment Status : Not yet recruiting
First Posted : December 14, 2017
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital Ostrava

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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: BMAC Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Retrograde Application of Bone Marrow Aspirate Concentrate (BMAC) Through Coronary Sinus in Patients With Congestive Heart Failure of Ischemic Etiology
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Bone marrow autologous cells concentrate (BMAC)
retrograde administration on non-selected BMAC via coronary sinus
Drug: BMAC
retrograde administration on non-selected BMAC via coronary sinus

Placebo Comparator: Control
standard treatment o heart failure
Drug: BMAC
retrograde administration on non-selected BMAC via coronary sinus




Primary Outcome Measures :
  1. Left ventricular end-systolic diameter (LVESd) [ Time Frame: 12 month ]
    Left ventricular end-systolic diameter

  2. Left ventricular end-systolic volume (LVESV) [ Time Frame: 12 month ]
    Left ventricular end-systolic volume

  3. Left ventricular end-diastolic diameter (LVEDd) [ Time Frame: 12 month ]
    Left ventricular end-diastolic diameter

  4. Left ventricular end-diastolic volume (LVEDV) [ Time Frame: 12 month ]
    Left ventricular end-diastolic volume

  5. ejection fraction of left ventricle (EF LV) [ Time Frame: 12 month ]
    ejection fraction of left ventricle


Secondary Outcome Measures :
  1. corridor walk test [ Time Frame: 12 month ]
    walk distance in 6 min corridor walk test

  2. QoL [ Time Frame: 12 month ]
    Quality of patients´ life using the Minnesota questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT03372954     History of Changes
Other Study ID Numbers: FNO-Retro
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases