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

NCT01693042 | Unknown Phase 2 DMC

• 2 other identifiers: 2011-01-01REPEAT2011-000595-33
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Heart Failure

Keywords

heart failure; old myocardial infarction; bone marrow-derived mononuclear cells; chronic; ischemic

Outcome Measures

Primary Outcomes (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)

  2 years

Secondary Outcomes (1)

• Morbidity at 2 and 5 years after inclusion into the study

  2 years and 5 years

Study Arms (2)

Single intracoronary cell application

ACTIVE COMPARATOR

Single intracoronary application of autologous bone marrow derived mononuclear cells

Biological: intracoronary infusion of autologous bone marrow-derived cells

repeated (2 times) intracoronary cell application

ACTIVE COMPARATOR

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

Biological: intracoronary infusion of autologous bone marrow-derived cells

Interventions

intracoronary infusion of autologous bone marrow-derived cells BIOLOGICAL

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

Also known as: t2c001

Single intracoronary cell application; repeated (2 times) intracoronary cell application

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital: lead

Study Sites (6)

Zentralklinik Bad Berka

Bad Berka, Germany

Location

Goethe University Frankfurt

Frankfurt, 60590, Germany

Location

Klinikum Fulda

Fulda, Germany

Location

Universitätsklinikum Mainz

Mainz, Germany

Location

Krankenhaus Hetzelstift

Neustadt, Germany

Location

Zentralklinikum Suhl

Suhl, Germany

Location

MeSH Terms

Conditions

Heart Failure; Bronchiolitis Obliterans Syndrome; Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas M Zeiher, MD

  Cardiology, Goethe University Frankfurt

  PRINCIPAL INVESTIGATOR

• Birgit Assmus, MD

  Cardiology, Goethe University Frankfurt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Andreas M. Zeiher

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: September 26, 2012
• Study Start: November 1, 2013
• Primary Completion: November 1, 2022
• Study Completion: January 1, 2025
• Last Updated: February 26, 2020

Record last verified: 2020-02

Locations

DE (6)