NCT00962364

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Acute Myocardial Infarction
• Ischemic Cardiomyopathy
• Dilated Cardiomyopathy
• Heart Failure

Interventions

Type	Name	Description
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

Timeline

• Start date: 2001-10-01
• Primary completion: 2020-12-01
• Completion: 2021-12-01
• First posted: 2009-08-20
• Last updated: 2020-02-26

Locations

1 site across 1 country: Germany