Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy

Conditions
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Cardiomyopathy, Dilated

Intervention / Treatment
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* Biological: Autologous stem cell therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient inclusion criteria consisted of the following: age 18-65 years old, diagnosis of DCM according to the European Society of Cardiology position statement (9), optimal medical management for at least 6 months, left ventricular ejection fraction (LVEF) <40%, and New York Heart Association functional Class III on stable medical therapy for at least 3 months before referral. Exclusion Criteria: Patients with acute multi-organ failure or a history of hematologic neoplasms were not included.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Autologous stem cell therapy|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transplantation-free survival | Survival after 5 years without undergoing heart transplantation | 5 years | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 5 years | 
| Changes in right ventricular function |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cell Therapy