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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Johann Wolfgang Goethe University Hospitals
Sponsor:
Information provided by (Responsible Party):
A. M. Zeiher, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00962364
First received: August 19, 2009
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Acute Myocardial Infarction
Ischemic Cardiomyopathy
Dilated Cardiomyopathy
Heart Failure
Biological: autologous bone marrow-derived cells

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Long-term Evaluation and Follow-up Care of Patients Receiving Intracoronary Bone Marrow-derived Cell Administration for Heart Disease

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Evaluation of procedural and long-term safety of intracoronary administration of bone marrow cells for the treatment for cardiac disease [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Serum and plasma from peripheral blood and bone marrow may me retained


Estimated Enrollment: 1500
Study Start Date: October 2001
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962364

Contacts
Contact: Andreas M Zeiher, Prof. Dr. +49 69 6301 ext 5789 zeiher@em.uni-frankfurt.de
Contact: Birgit Assmus, PD Dr. +49 69 6301 ext 7387 b.assmus@em.uni-frankfurt.de

Locations
Germany
Cardiology, Department of Internal Medicine III Recruiting
Frankfurt, Germany, 60590
Contact: Andreas M Zeiher, Prof. Dr.    +49 69 6301 ext 5789    zeiher@em.uni-frankfurt.de   
Contact: Birgit Assmus, PD Dr.    +49 69 6301 ext 7387    b.assmus@em.uni-frankfurt.de   
Principal Investigator: Andreas M Zeiher, Prof. Dr         
Sub-Investigator: Birgit Assmus, PD Dr.         
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Principal Investigator: Andreas M Zeiher, Prof. Dr Cardiology, Goethe University Frankfurt, Germany
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: A. M. Zeiher, Prof. Dr. Andreas M. Zeiher, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT00962364     History of Changes
Other Study ID Numbers: 201-01-BMC-Reg
Study First Received: August 19, 2009
Last Updated: November 14, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Heart Failure
Infarction
Myocardial Infarction
Cardiomegaly
Cardiovascular Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014