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

NCT ID: NCT01693042

Last Updated: 2020-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2025-01-31

Brief Summary

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single intracoronary cell application

Single intracoronary application of autologous bone marrow derived mononuclear cells

Group Type: ACTIVE_COMPARATOR

intracoronary infusion of autologous bone marrow-derived cells

Intervention Type: BIOLOGICAL

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

repeated (2 times) intracoronary cell application

2 times (interval 4 months) intracoronary application of autologous bone marrow derived mononuclear cells

Group Type: ACTIVE_COMPARATOR

intracoronary infusion of autologous bone marrow-derived cells

Intervention Type: BIOLOGICAL

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

Interventions

intracoronary infusion of autologous bone marrow-derived cells

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

Intervention Type: BIOLOGICAL

Other Intervention Names

t2c001

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role: lead

Responsible Party

A. M. Zeiher

Prof. Dr. Andreas M. Zeiher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas M Zeiher, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiology, Goethe University Frankfurt

Birgit Assmus, MD

Role: STUDY_DIRECTOR

Cardiology, Goethe University Frankfurt

Locations

Zentralklinik Bad Berka

Bad Berka, , Germany

Goethe University Frankfurt

Frankfurt, , Germany

Klinikum Fulda

Fulda, , Germany

Universitätsklinikum Mainz

Mainz, , Germany

Krankenhaus Hetzelstift

Neustadt, , Germany

Zentralklinikum Suhl

Suhl, , Germany

Countries

Germany

Other Identifiers

2011-000595-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2011-01-01REPEAT

Identifier Type: -

Identifier Source: org_study_id