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

Heart Failure Clinical Trial

— BMC registry  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00962364
• Other study ID #: 201-01-BMC-Reg
• Status: Active, not recruiting
• Start date: October 2001
• Est. completion date: December 2021

Study information

• Verified date: February 2020
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy
• Heart Diseases
• Heart Failure
• Infarction
• Ischemic Cardiomyopathy
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
Germany	Cardiology, Department of Internal Medicine III	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Assmus B, Fischer-Rasokat U, Honold J, Seeger FH, Fichtlscherer S, Tonn T, Seifried E, Schächinger V, Dimmeler S, Zeiher AM; TOPCARE-CHD Registry. Transcoronary transplantation of functionally competent BMCs is associated with a decrease in natriuretic pe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of procedural and long-term safety of intracoronary administration of bone marrow cells for the treatment for cardiac disease		10 years