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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00962364
First Posted: August 20, 2009
Last Update Posted: March 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
A. M. Zeiher, Johann Wolfgang Goethe University Hospital
August 19, 2009
August 20, 2009
March 21, 2017
October 2001
December 2017   (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 ]
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.
 
Active, not recruiting
1500
December 2021
December 2017   (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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00962364
201-01-BMC-Reg
No
Not Provided
Not Provided
A. M. Zeiher, Johann Wolfgang Goethe University Hospital
Johann Wolfgang Goethe University Hospital
Not Provided
Principal Investigator: Andreas M Zeiher, Prof. Dr Cardiology, Goethe University Frankfurt, Germany
Johann Wolfgang Goethe University Hospital
March 2017