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 (REPEAT)

February 25, 2020 updated by: A. M. Zeiher, Johann Wolfgang Goethe University Hospital

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Berka, Germany
        • Zentralklinik Bad Berka
      • Frankfurt, Germany, 60590
        • Goethe University Frankfurt
      • Fulda, Germany
        • Klinikum Fulda
      • Mainz, Germany
        • Universitätsklinikum Mainz
      • Neustadt, Germany
        • Krankenhaus Hetzelstift
      • Suhl, Germany
        • Zentralklinikum Suhl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Single intracoronary cell application
Single intracoronary application of autologous bone marrow derived mononuclear cells
Biological: intracoronary infusion of autologous bone marrow-derived cells
Intracoronary infusion into open vessel / bypass supplying previous (> 3 months) infarct area
Other Names:
  • t2c001
ACTIVE_COMPARATOR: repeated (2 times) intracoronary cell application
2 times (interval 4 months) intracoronary application of autologous bone marrow derived mononuclear cells
Biological: intracoronary infusion of autologous bone marrow-derived cells
Intracoronary infusion into open vessel / bypass supplying previous (> 3 months) infarct area
Other Names:
  • t2c001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality at 2 years after inclusion into the study
Time Frame: 2 years
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)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity at 2 and 5 years after inclusion into the study
Time Frame: 2 years and 5 years

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
2 years and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Investigators

  • Principal Investigator: Andreas M Zeiher, MD, Cardiology, Goethe University Frankfurt
  • Study Director: Birgit Assmus, MD, Cardiology, Goethe University Frankfurt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ANTICIPATED)

November 1, 2022

Study Completion (ANTICIPATED)

January 1, 2025

Study Registration Dates

First Submitted

September 19, 2012

First Submitted That Met QC Criteria

September 21, 2012

First Posted (ESTIMATE)

September 26, 2012

Study Record Updates

Last Update Posted (ACTUAL)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 25, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-01-01REPEAT
  • 2011-000595-33 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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