Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-31 @ 2:18 PM
Study NCT ID:
NCT02445534
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2015-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy
Sponsor:
University Medical Centre Ljubljana
Organization:
Study Overview
Official Title:
Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECORD
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: