Long-term Evaluation of Patients Receiving Bone Marrow-derived Cell Administration for Heart Disease (BMC registry)

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

Long-term Evaluation and Follow-up Care of Patients Receiving Intracoronary Bone Marrow-derived Cell Administration for Heart Disease

This study will provide follow-up information and care of patients who have undergone autologous intracoronary bone marrow cell administration at our institution. Patients are monitored for their response to treatment, progression of heart failure and coronary artery disease, and potential later occurring effects of the administered bone marrow cells.

Patients are eligible for this follow-up study if they have received their first intracoronary bone marrow cell administration for the treatment of cardiac disease at our institution from 2001 ongoing.

Participants are generally seen in the clinic at 12 months and 5 years after cell administration, in the meantime regular yearly telephone contacts are performed until 10 years after cell transplantation.

The detailed description contains the planned procedures that are performed during the clinical visits and, if necessary, at additional contacts.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In detail, the following procedures are performed during the clinical visits and, if necessary, at additional contacts:

  • periodic physical examination and blood tests
  • non-invasive imaging studies may include echocardiography and magnetic resonance imaging
  • electrocardiogram at rest and during treadmill testing (may include spiroergometry testing)
  • interrogation of implanted defibrillators / pacemakers for monitoring of arrhythmias

Study Type

Observational

Enrollment (Anticipated)

1500

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
        • Cardiology, Department of Internal Medicine III

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients suffering from heart disease with consecutive signs of heart failure, treated in our clinic or being referred for cell therapy

Description

Inclusion Criteria: Clinical diagnosis of heart disease with signs and symptoms of heart failure due to

  • acute myocardial infarction or
  • ischemic cardiomyopathy with or without previous myocardial infarction or
  • dilated cardiomyopathy due to valvular heart disease, hypertensive heart disease, history of myocarditis (no active myocardial infection present)

Exclusion Criteria:

  • none, all patients meeting the inclusion criteria will be eligible.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AMI
Patients with acute myocardial infarction treated with intracoronary administration of bone marrow derived cells
Biological: autologous bone marrow-derived cells
autologous bone marrow-derived cells isolated by density gradient centrifugation from 50 ml bone marrow aspirate obtained under local anesthesia
ICM
Patients with ischemic cardiomyopathy treated with intracoronary administration of bone marrow derived cells
Biological: autologous bone marrow-derived cells
autologous bone marrow-derived cells isolated by density gradient centrifugation from 50 ml bone marrow aspirate obtained under local anesthesia
DCM
Patients with dilated cardiomyopathy treated with intracoronary administration of bone marrow derived cells
Biological: autologous bone marrow-derived cells
autologous bone marrow-derived cells isolated by density gradient centrifugation from 50 ml bone marrow aspirate obtained under local anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of procedural and long-term safety of intracoronary administration of bone marrow cells for the treatment for cardiac disease
Time Frame: 10 years
10 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, Prof. Dr, Cardiology, Goethe University Frankfurt, Germany

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

Helpful Links

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

October 1, 2001

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

August 19, 2009

First Submitted That Met QC Criteria

August 19, 2009

First Posted (Estimate)

August 20, 2009

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201-01-BMC-Reg

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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