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

• Conditions: Dilated Cardiomyopathy; Heart Failure; Ischemic Cardiomyopathy; Acute Myocardial Infarction
• Interventions: Biological: autologous bone marrow-derived cells

• Registration Number: NCT00962364
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief 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

Study Timeline

• Study Start: 2001-10
• Study First Submitted: 2009-08-19
• Study First Submitted QC: 2009-08-19
• Study First Posted: 2009-08-20
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-25
• Last Update Posted: 2020-02-26
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICM	autologous bone marrow-derived cells	Patients with ischemic cardiomyopathy treated with intracoronary administration of bone marrow derived cells
AMI	autologous bone marrow-derived cells	Patients with acute myocardial infarction treated with intracoronary administration of bone marrow derived cells
DCM	autologous bone marrow-derived cells	Patients with dilated cardiomyopathy treated with intracoronary administration of bone marrow derived cells

Primary Outcome Measures

Name	Time	Method
Evaluation of procedural and long-term safety of intracoronary administration of bone marrow cells for the treatment for cardiac disease	10 years

Trial Locations

Locations (1)

Cardiology, Department of Internal Medicine III; 🇩🇪 Frankfurt, Germany