Long-term Evaluation of Patients Receiving Bone Marrow-derived Cell Administration for Heart Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Acute Myocardial Infarction, Ischemic Cardiomyopathy, Dilated Cardiomyopathy, Heart Failure

Intervention / Treatment
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* Biological: autologous bone marrow-derived cells


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of procedural and long-term safety of intracoronary administration of bone marrow cells for the treatment for cardiac disease |  | 10 years |