Cell-Wave Study: Combined Extracorporal Shock Wave Therapy and Intracoronary Cell Therapy in Chronic Ischemic Myocardium

March 20, 2017 updated by: A. M. Zeiher, Johann Wolfgang Goethe University Hospital

Extracorporal Shock Wave Therapy for Induction of Therapeutic Neovascularization and Homing of Bone Marrow Progenitor Cells in Patients With Chronic Ischemic Heart Disease

Extracorporal shock wave therapy is performed prior to cell therapy for induction of therapeutic neovascularization and improvement of homing of bone marrow progenitor cells in patients with chronic ischemic heart disease following anterior myocardial infarction.

Shock waves can induce growth factor expression in the ischemic myocardium and might augment homing of autologous bone marrow mononuclear cells which are injected intracoronary 24 h following shock wave therapy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Single center, Phase I-II Study (Safety, Feasibility and Efficacy) Double-blind, randomised trial (Cell therapy), single blind (Shockwave)

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 2
  • Phase 1

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
      • Frankfurt, Germany, 60590
        • Div. of Cardiology , University of Frankfurt

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:

  • Patients with chronic ischemic heart disease
  • Patients with anterior myocardial infarction > 3months
  • EF < 50% or NYHA II-IV
  • Age 18-80
  • Informed consent

Exclusion Criteria:

  • Ventricular thrombus
  • Infarct < 3 months.
  • Active infection or fever
  • Chronic inflammatory disease (e.g M. Crohn, Rheumatoid Arthritis)
  • HIV Infection oder active Hepatitis
  • Neoplastic disease w/o complete remission within 5 years
  • Stroke < 3months
  • Creatinine > 2 mg/dl
  • Relevant Liver disease (GOT > twice the upper limit).
  • Anemia (Hemoglobin <10 mg/dl)
  • Thrombocytopenia < 100.000/µl
  • Allergies to Aspirin, Clopidogrel, Heparin
  • History of bleeding disorder
  • History of coagulopathy
  • Gastrointestinal Bleeding < 3 months
  • Surgery or Trauma < 2 months
  • Pregnancy
  • Mental Retardation
  • Participation in other clinical study < 1 month

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low-dose shock wave treatment & Placebo
Procedure: intracoronary stem cell therapy
extracorporal shock waves prior to intracoronary cell therapy
Active Comparator: low-dose shock-wave treatment & Cell therapy
Procedure: intracoronary stem cell therapy
extracorporal shock waves prior to intracoronary cell therapy
Active Comparator: High-dose shock-wave treatment & Placebo
Procedure: intracoronary stem cell therapy
extracorporal shock waves prior to intracoronary cell therapy
Active Comparator: High-dose shock-wave treatment & cell therapy
Procedure: intracoronary stem cell therapy
extracorporal shock waves prior to intracoronary cell therapy
Active Comparator: Placebo shock-wave treatment & cell therapy
Procedure: intracoronary stem cell therapy
extracorporal shock waves prior to intracoronary cell therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in global ejection fraction on LV angiography
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Global or regional wall motion at 4 months and 1 year
Time Frame: 4 months
4 months
NYHA Class
Time Frame: 4 months
4 months
NT BNP levels
Time Frame: 4 months
4 months
MACE
Time Frame: 4 months
4 months
Life quality
Time Frame: 4 months
4 months

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, Div. of Cardiology, University of Frankfurt, Germany
  • Study Director: Dirk H Walter, MD, Div. of Cardiology, University of Frankfurt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2006

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

May 16, 2006

First Submitted That Met QC Criteria

May 16, 2006

First Posted (Estimate)

May 17, 2006

Study Record Updates

Last Update Posted (Actual)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 20, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-005709-50
  • Cellwave CHF

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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