NCT02445534

Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: University Medical Centre Ljubljana · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Cardiomyopathy, Dilated

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2005-01-01
• Primary completion: 2027-01-01
• Completion: 2027-05-01
• First posted: 2015-05-15
• Last updated: 2024-07-03

Locations

1 site across 1 country: Slovenia