Heart FailurePhase 2RetroNCT03372954
Retrograde Application of Bone Marrow Aspirate Concentrate
A Phase 2 study testing BMAC in people with Heart Failure, run by University Hospital Ostrava at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- BMAC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2018to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava-Poruba, Moravian-Silesian Region, 708 52
About this study
Official title: Retrograde Application of Bone Marrow Aspirate Concentrate (BMAC) Through Coronary Sinus in Patients With Congestive Heart Failure of Ischemic Etiology
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- BMAC
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMACDrug
retrograde administration on non-selected BMAC via coronary sinus
| Study group | Role | What they receive |
|---|---|---|
| Bone marrow autologous cells concentrate (BMAC) | Experimental | retrograde administration on non-selected BMAC via coronary sinus Receives: Drug: BMAC |
| Control | Placebo comparator | standard treatment o heart failure Receives: Drug: BMAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular end-systolic diameter (LVESd)
Left ventricular end-systolic diameter
Measured: 12 month
Left ventricular end-systolic volume (LVESV)
Left ventricular end-systolic volume
Measured: 12 month
Left ventricular end-diastolic diameter (LVEDd)
Left ventricular end-diastolic diameter
Measured: 12 month
Left ventricular end-diastolic volume (LVEDV)
Left ventricular end-diastolic volume
Measured: 12 month
ejection fraction of left ventricle (EF LV)
ejection fraction of left ventricle
Measured: 12 month
Secondary outcomes (2)
corridor walk test
walk distance in 6 min corridor walk test
Measured: 12 month
QoL
Quality of patients´ life using the Minnesota questionnaire
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start1 Jan 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leoš Pleva, MD,PhD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372954
- Sponsor's protocol ID
- FNO-Retro
- Acronym
- Retro
- Status last verified
- Dec 2022
- First submitted
- 10 Dec 2017
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There exists no plan to make individual participant data available to other researchers. The data may be provided upon request.
Publications
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.
PubMed 30704414
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrograde Application of Bone Marrow Aspirate Concentrate (BMAC) Through Coronary Sinus in Patients With Congestive Heart Failure of Ischemic Etiology
- ClinicalTrials.gov ID
- NCT03372954
- Acronym / sponsor ID
- Retro / FNO-Retro
- Conditions
- Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone marrow autologous cells concentrate (BMAC) | Experimental | Drug: BMACretrograde administration on non-selected BMAC via coronary sinus |
| Control | Placebo comparator | Drug: BMACstandard treatment o heart failure |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMACretrograde administration on non-selected BMAC via coronary sinus | Drug | Bone marrow autologous cells concentrate (BMAC), Control |
Primary outcome
Left ventricular end-systolic diameter (LVESd)
Time frame: 12 month
Left ventricular end-systolic diameter
Left ventricular end-systolic volume (LVESV)
Time frame: 12 month
Left ventricular end-systolic volume
Left ventricular end-diastolic diameter (LVEDd)
Time frame: 12 month
Left ventricular end-diastolic diameter
Left ventricular end-diastolic volume (LVEDV)
Time frame: 12 month
Left ventricular end-diastolic volume
ejection fraction of left ventricle (EF LV)
Time frame: 12 month
ejection fraction of left ventricle
2 secondary outcomes
corridor walk test
Time frame: 12 month
QoL
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Derived from this study: PubMed 30704414Pleva 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.
- Individual participant dataSharing planned: No. There exists no plan to make individual participant data available to other researchers. The data may be provided upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leoš Pleva, MD,PhD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMAC in people with Heart Failure, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular end-systolic diameter (LVESd) (time frame: 12 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03372954, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022; AzTrials last refreshed its copy on 6 Nov 2026.