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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.
In detail, the following procedures are performed during the clinical visits and, if necessary, at additional contacts:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMI | Patients with acute myocardial infarction treated with intracoronary administration of bone marrow derived cells |
| |
| ICM | Patients with ischemic cardiomyopathy treated with intracoronary administration of bone marrow derived cells |
| |
| DCM | Patients with dilated cardiomyopathy treated with intracoronary administration of bone marrow derived cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous bone marrow-derived cells | Biological | autologous bone marrow-derived cells isolated by density gradient centrifugation from 50 ml bone marrow aspirate obtained under local anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of procedural and long-term safety of intracoronary administration of bone marrow cells for the treatment for cardiac disease | 10 years |
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Inclusion Criteria: Clinical diagnosis of heart disease with signs and symptoms of heart failure due to
Exclusion Criteria:
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Patients suffering from heart disease with consecutive signs of heart failure, treated in our clinic or being referred for cell therapy
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| Name | Affiliation | Role |
|---|---|---|
| Andreas M Zeiher, Prof. Dr | Cardiology, Goethe University Frankfurt, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology, Department of Internal Medicine III | Frankfurt | 60590 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17379833 | Result | Assmus B, Fischer-Rasokat U, Honold J, Seeger FH, Fichtlscherer S, Tonn T, Seifried E, Schachinger V, Dimmeler S, Zeiher AM; TOPCARE-CHD Registry. Transcoronary transplantation of functionally competent BMCs is associated with a decrease in natriuretic peptide serum levels and improved survival of patients with chronic postinfarction heart failure: results of the TOPCARE-CHD Registry. Circ Res. 2007 Apr 27;100(8):1234-41. doi: 10.1161/01.RES.0000264508.47717.6b. Epub 2007 Mar 22. | |
| 28351842 |
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Serum and plasma from peripheral blood and bone marrow may me retained
| Derived |
| Luu B, Leistner DM, Herrmann E, Seeger FH, Honold J, Fichtlscherer S, Zeiher AM, Assmus B. Minute Myocardial Injury as Measured by High-Sensitive Troponin T Serum Levels Predicts the Response to Intracoronary Infusion of Bone Marrow-Derived Mononuclear Cells in Patients With Stable Chronic Post-Infarction Heart Failure: Insights From the TOPCARE-CHD Registry. Circ Res. 2017 Jun 9;120(12):1938-1946. doi: 10.1161/CIRCRESAHA.116.309938. Epub 2017 Mar 28. |
| 23612920 | Derived | Honold J, Fischer-Rasokat U, Seeger FH, Leistner D, Lotz S, Dimmeler S, Zeiher AM, Assmus B. Impact of intracoronary reinfusion of bone marrow-derived mononuclear progenitor cells on cardiopulmonary exercise capacity in patients with chronic postinfarction heart failure. Clin Res Cardiol. 2013 Sep;102(9):619-25. doi: 10.1007/s00392-013-0574-1. Epub 2013 Apr 24. |
| 23362308 | Derived | De Rosa S, Seeger FH, Honold J, Fischer-Rasokat U, Lehmann R, Fichtlscherer S, Schachinger V, Dimmeler S, Zeiher AM, Assmus B. Procedural safety and predictors of acute outcome of intracoronary administration of progenitor cells in 775 consecutive procedures performed for acute myocardial infarction or chronic heart failure. Circ Cardiovasc Interv. 2013 Feb;6(1):44-51. doi: 10.1161/CIRCINTERVENTIONS.112.971705. Epub 2013 Jan 29. |
| 22936827 | Derived | Leistner DM, Seeger FH, Fischer A, Roxe T, Klotsche J, Iekushi K, Seeger T, Assmus B, Honold J, Karakas M, Badenhoop K, Frantz S, Dimmeler S, Zeiher AM. Elevated levels of the mediator of catabolic bone remodeling RANKL in the bone marrow environment link chronic heart failure with osteoporosis. Circ Heart Fail. 2012 Nov;5(6):769-77. doi: 10.1161/CIRCHEARTFAILURE.111.966093. Epub 2012 Aug 30. |
| 22651868 | Derived | Xu Q, Seeger FH, Castillo J, Iekushi K, Boon RA, Farcas R, Manavski Y, Li YG, Assmus B, Zeiher AM, Dimmeler S. Micro-RNA-34a contributes to the impaired function of bone marrow-derived mononuclear cells from patients with cardiovascular disease. J Am Coll Cardiol. 2012 Jun 5;59(23):2107-17. doi: 10.1016/j.jacc.2012.02.033. |
| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
| D000083083 | Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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