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

August 19, 2009
November 14, 2013
October 2001
December 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00962364 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Long-term Evaluation of Patients Receiving Bone Marrow-derived Cell Administration for Heart Disease
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.

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
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

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

  • Acute Myocardial Infarction
  • Ischemic Cardiomyopathy
  • Dilated Cardiomyopathy
  • Heart Failure
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
  • AMI
    Patients with acute myocardial infarction treated with intracoronary administration of bone marrow derived cells
    Intervention: Biological: autologous bone marrow-derived cells
  • ICM
    Patients with ischemic cardiomyopathy treated with intracoronary administration of bone marrow derived cells
    Intervention: Biological: autologous bone marrow-derived cells
  • DCM
    Patients with dilated cardiomyopathy treated with intracoronary administration of bone marrow derived cells
    Intervention: Biological: autologous bone marrow-derived cells

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
December 2016
December 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
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
Germany
 
NCT00962364
201-01-BMC-Reg
No
A. M. Zeiher, Johann Wolfgang Goethe University Hospitals
Johann Wolfgang Goethe University Hospitals
Not Provided
Principal Investigator: Andreas M Zeiher, Prof. Dr Cardiology, Goethe University Frankfurt, Germany
Johann Wolfgang Goethe University Hospitals
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP