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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-10-31

Study Completion Date

2021-12-31

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.

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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

Conditions

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Acute Myocardial Infarction Ischemic Cardiomyopathy Dilated Cardiomyopathy Heart Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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AMI

Patients with acute myocardial infarction treated with intracoronary administration of bone marrow derived cells

autologous bone marrow-derived cells

Intervention Type BIOLOGICAL

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

autologous bone marrow-derived cells

Intervention Type BIOLOGICAL

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

autologous bone marrow-derived cells

Intervention Type BIOLOGICAL

autologous bone marrow-derived cells isolated by density gradient centrifugation from 50 ml bone marrow aspirate obtained under local anesthesia

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No