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

Johann Wolfgang Goethe University Hospital

Status: Unknown

Conditions: Heart Failure; Acute Myocardial Infarction; Dilated Cardiomyopathy; Ischemic Cardiomyopathy

Treatments: Biological: autologous bone marrow-derived cells

Study type: Observational

Funder types: Other

Identifiers

NCT00962364

201-01-BMC-Reg

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

1,500 participants in 3 patient groups

AMI

Description:

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

Treatment:

Biological: autologous bone marrow-derived cells

ICM

Description:

Patients with ischemic cardiomyopathy treated with intracoronary administration of bone marrow derived cells

Treatment:

Biological: autologous bone marrow-derived cells

DCM

Description:

Patients with dilated cardiomyopathy treated with intracoronary administration of bone marrow derived cells

Treatment:

Biological: autologous bone marrow-derived cells