Retrograde Application of Bone Marrow Aspirate Concentrate

NCT03372954 | Completed Phase 2 DMC

• 1 other identifier: FNO-Retro
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (5)

• Left ventricular end-systolic diameter (LVESd)

  Left ventricular end-systolic diameter

  12 month

• Left ventricular end-systolic volume (LVESV)

  Left ventricular end-systolic volume

  12 month

• Left ventricular end-diastolic diameter (LVEDd)

  Left ventricular end-diastolic diameter

  12 month

• Left ventricular end-diastolic volume (LVEDV)

  Left ventricular end-diastolic volume

  12 month

• ejection fraction of left ventricle (EF LV)

  ejection fraction of left ventricle

  12 month

Secondary Outcomes (2)

• corridor walk test

  12 month

• QoL

  12 month

Study Arms (2)

Bone marrow autologous cells concentrate (BMAC)

EXPERIMENTAL

retrograde administration on non-selected BMAC via coronary sinus

Drug: BMAC

Control

PLACEBO COMPARATOR

standard treatment o heart failure

Drug: BMAC

Interventions

BMAC DRUG

retrograde administration on non-selected BMAC via coronary sinus

Bone marrow autologous cells concentrate (BMAC); Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava-Poruba, Moravian-Silesian Region, 708 52, Czechia

Location

Related Publications (1)

• 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.

  PMID: 30704414 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Leoš Pleva, MD,PhD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2017
• First Posted: December 14, 2017
• Study Start: January 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)