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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00962364
Acronym
BMC registry
Enrollment
1500
Registered
2009-08-20
Start date
2001-10-31
Completion date
2021-12-31
Last updated
2020-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

BIOLOGICALautologous bone marrow-derived cells

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

Sponsors

Johann Wolfgang Goethe University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Evaluation of procedural and long-term safety of intracoronary administration of bone marrow cells for the treatment for cardiac disease10 years

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026