AzTrials
AzTrials

Heart FailurePhase 2/3REPEATNCT01693042

Compare the Effects of Single Versus Repeated Intracoronary Application of Autologous Bone Marrow-derived Mononuclear Cells on Mortality in Patients With Chronic Post-infarction Heart Failure

A Phase 2/3 study testing intracoronary infusion of autologous bone marrow-derived cells in people with Heart Failure, run by Johann Wolfgang Goethe University Hospital at 6 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Single or repeated application of autologous bone marrow-derived stem cells to treat chronic post-infarction heart failure Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Heart Failure
What is being tested?
intracoronary infusion of autologous bone marrow-derived cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
6 sitesGermany
Study dates
Nov 2013to Jan 2025
Phase
Phase 2/3
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Previous myocardial infarction at least 3 months ago, open infarct vessel or bypass
  • Left ventricular ejection fraction (LVEF) ≤ 45% on echocardiography
  • Stable chronic heart failure NYHA class II to III under constant (4 weeks) evidence-based optimal medical treatment
  • age 18 - 80 years
  • written informed consent
  • women of childbearing age: negative pregnancy test; effective contraception for the first 8 months in the trial

Who cannot join

  • Non-ischemic cardiomyopathy
  • Necessity for revascularization in other vessel than the infarct vessel at the time of study therapy
  • Hemodynamic relevant severe valvular disease with indication for operative / interventional revision
  • Heart failure with preserved ejection fraction (diastolic heart failure), LVEF > 45%
  • Unstable Angina
  • Severe peripheral artery occlusive disease (≥ Fontaine stadium III)
Show all 22Show fewer
  • Active infection (C-reactive protein > 10 mg/dl), chronic active hepatitis; any chronic inflammatory disease, HIV infection
  • Neoplastic disease without documented remission in the last 5 years
  • Stroke ≤ 3 months
  • Impaired renal function (Serum creatinine > 2,5 mg/dl) at the time of study inclusion
  • Relevant liver disease (GOT > 2x upper normal limit, spontaneous INR > 1,5).
  • Diseases of hematopoetic system, anemia (Hemoglobin < 8.5 mg/dl), thrombocytopenia < 100.000/µl)
  • Splenomegaly
  • Allergy or intolerance of clopidogrel, prasugrel, ticagrelor, heparin, bivalirudin
  • History of bleeding disorder
  • gastrointestinal bleeding ≤ 3 months
  • major surgery or trauma ≤ 3 months
  • Uncontrolled hypertension
  • Pregnancy, lactation period
  • mental retardation
  • previous cardiac cell therapy within last 12 months
  • Participation in another clinical trial ≤ 30 days

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites

  • Zentralklinik Bad Berka

    Bad Berka

  • Goethe University Frankfurt

    Frankfurt, 60590

  • Klinikum Fulda

    Fulda

  • Universitätsklinikum Mainz

    Mainz

  • Krankenhaus Hetzelstift

    Neustadt

  • Zentralklinikum Suhl

    Suhl

Other trials in Germany

About this study

Official title: Randomized Controlled Trial to Compare the Effects of Single Versus Repeated Intracoronary Application of Autologous Bone Marrow-derived Mononuclear Cells on Total and SHFM-predicted Mortality in Patients With Chronic Post-infarction Heart Failure

Single or repeated application of autologous bone marrow-derived stem cells to treat chronic post-infarction heart failure

Read the detailed description

Improve mortality and morbidity in patients with symptomatic chronic post-infarction heart failure under full dose conventional medical and device treatment including resynchronization therapy, by single versus repeated intracoronary infusion of autologous bone marrow-derived mononuclear cells.

Conditions
Heart Failure
Being tested
intracoronary infusion of autologous bone marrow-derived cells
Keywords
heart failure, old myocardial infarction, bone marrow-derived mononuclear cells, chronic, ischemic
Medical subject headings
Heart Failure, Bronchiolitis Obliterans Syndrome, Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intracoronary infusion of autologous bone marrow-derived cellsBiological

    Also called t2c001

    Intracoronary infusion into open vessel / bypass supplying previous (> 3 months) infarct area

Study groups in NCT01693042
Study groupRoleWhat they receive
Single intracoronary cell applicationActive comparatorSingle intracoronary application of autologous bone marrow derived mononuclear cells
Receives: Biological: intracoronary infusion of autologous bone marrow-derived cells
repeated (2 times) intracoronary cell applicationActive comparator2 times (interval 4 months) intracoronary application of autologous bone marrow derived mononuclear cells
Receives: Biological: intracoronary infusion of autologous bone marrow-derived cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality at 2 years after inclusion into the study

    2-year observed mortality is significantly lower in patients receiving 2 repeated intracoronary applications of autologous bone marrow-derived cells (t2c001) compared to patients receiving 1 intracoronary application of autologous bone marrow-derived cells (t2c001)

    Measured: 2 years

Secondary outcomes (1)

  1. Morbidity at 2 and 5 years after inclusion into the study

    Efficacy endpoints:

    Comparison between the 2 treatment groups at 2-year and 5-year follow-up

    • Cardiac mortality, cardiovascular mortality
    • Rehospitalisation for heart failure
    • Ischemic cardiac events (STEMI, NSTEMI, ACS)
    • Coronary revascularisations (PCI / CABG)
    • Heart transplantation, Assist-device implantation
    • New resynchronization therapy, ICD implantation
    • NYHA-Status, NT-proBNP serum levels
    • Minnesota Living with Heart Failure Questionnaire

    Safety endpoints:

    bleeding events, all in-hospital events (during hospitalization for BMC therapy), life-threatening arrhythmias, new malignancies

    Measured: 2 years and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2012 (estimated)
  2. Study startNov 2013
  3. Primary completionNov 2022 (estimated)
  4. Study completionJan 2025 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01693042
Sponsor's protocol ID
2011-01-01REPEAT
Other IDs
2011-000595-33
Acronym
REPEAT
Status last verified
Feb 2020
First submitted
19 Sep 2012
Last updated
26 Feb 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing intracoronary infusion of autologous bone marrow-derived cells in people with Heart Failure, run by Johann Wolfgang Goethe University Hospital at 6 sites in Germany.

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 6 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Mortality at 2 years after inclusion into the study (time frame: 2 years). 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 NCT01693042.

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 26 Feb 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in