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Retrograde Application of Bone Marrow Aspirate Concentrate

NCT ID: NCT03372954

Last Updated: 2022-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Bone marrow autologous cells concentrate (BMAC)

retrograde administration on non-selected BMAC via coronary sinus

Group Type EXPERIMENTAL

BMAC

Intervention Type DRUG

retrograde administration on non-selected BMAC via coronary sinus

Control

standard treatment o heart failure

Group Type PLACEBO_COMPARATOR

BMAC

Intervention Type DRUG

retrograde administration on non-selected BMAC via coronary sinus

Interventions

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BMAC

retrograde administration on non-selected BMAC via coronary sinus

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Ostrava

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leoš Pleva, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ostrava

Locations

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University Hospital Ostrava

Ostrava-Poruba, Moravian-Silesian Region, Czechia

Site Status

Countries

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Czechia

References

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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.

Reference Type DERIVED
PMID: 30704414 (View on PubMed)

Other Identifiers

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FNO-Retro

Identifier Type: -

Identifier Source: org_study_id