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Although several studies have demonstrated beneficial effects of stem cell therapy in patients with non-ischemic dilated cardiomyopathy, the long term benefits and predictors of response to therapy remain undefined. The aim of this registry is to pool long-term clinical data in patients with non-ischemic dilated cardiomyopathy undergoing autologous cell therapy in an attempt to better define predictors of response to such treatment.
Registry will include all patients who underwent intracoronary or intramyocardial cell therapy as a part of clinical trials performed at UMC Ljubljana from January 2005 until January 2018. Patients will be followed on regular basis in a dedicated heart failure outpatient clinic, clinical data will be collected and stored in a secure central database. Data will be analyzed in periodic intervals by an independent Data monitoring board in an attempt to better define the predictors of clinical response to cell therapy in this patient population.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous stem cell therapy | Biological | All patients received granulocyte-colony stimulating factor (G-CSF; 5 mg/kg, 5 days). CD34+ cell were then collected by apheresis and injected transendocardially or intracororonary. |
| Measure | Description | Time Frame |
|---|---|---|
| Transplantation-free survival | Survival after 5 years without undergoing heart transplantation | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in left ventricular ejection fraction | 5 years | |
| Changes in left ventricular dimensions | 5 years | |
| Changes in left ventricular diastolic function |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in exercise capacity | 5 years | |
| Changes in NT-proBNP | 5 years |
Inclusion Criteria:
Exclusion Criteria:
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All patients enrolled in clinical trials of stem cell therapy in non-ischemic dilated cardiomyopathy at UMC Ljubljana from January, 2005 will be enrolled.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bojan Vrtovec, MD, PhD | Contact | +3861 522 1157 | bojan.vrtovec@gmail.com | |
| Gregor Poglajen, MD, PhD | Contact | +3861 522 1148 | gregor.poglajen@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Bojan Vrtovec, MD, PhD | UMC Ljubljana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC Ljubljana | Recruiting | Ljubljana | 1000 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33012343 | Derived | Frljak S, Poglajen G, Zemljic G, Cerar A, Haddad F, Terzic A, Vrtovec B. Larger End-Diastolic Volume Associates With Response to Cell Therapy in Patients With Nonischemic Dilated Cardiomyopathy. Mayo Clin Proc. 2020 Oct;95(10):2125-2133. doi: 10.1016/j.mayocp.2020.02.031. | |
| 28296283 | Derived | Bervar M, Kozelj M, Poglajen G, Sever M, Zemljic G, Frljak S, Cukjati M, Cernelc P, Haddad F, Vrtovec B. Effects of Transendocardial CD34+ Cell Transplantation on Diastolic Parameters in Patients with Nonischemic Dilated Cardiomyopathy. Stem Cells Transl Med. 2017 Jun;6(6):1515-1521. doi: 10.1002/sctm.16-0331. Epub 2017 Mar 11. |
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| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
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| 5 years |
| Changes in right ventricular function | 5 years |
| D000083083 |
| Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |