Long-term Evaluation of Patients Receiving Bone Marrow-derived Cell Administration for Heart Disease (BMC registry)
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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 |
- 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 |
| 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 |
Patients suffering from heart disease with consecutive signs of heart failure, treated in our clinic or being referred for cell therapy
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| 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 | |
| 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. | |
| 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: | September 19, 2012 |
| Health Authority: | Germany: Ethics Commission |
Additional relevant MeSH terms:
|
Cardiomyopathy, Dilated Heart Diseases Heart Failure Infarction Myocardial Infarction Cardiomyopathies Cardiomegaly |
Cardiovascular Diseases Ischemia Pathologic Processes Necrosis Myocardial Ischemia Vascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013