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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02445534
Other study ID # RECORD
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2005
Est. completion date May 2024

Study information

Verified date May 2023
Source University Medical Centre Ljubljana
Contact Bojan Vrtovec, MD, PhD
Phone +3861 522 1157
Email bojan.vrtovec@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date May 2024
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Slovenia UMC Ljubljana Ljubljana

Sponsors (1)

Lead Sponsor Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type Measure Description Time frame Safety issue
Other Changes in exercise capacity 5 years
Other Changes in NT-proBNP 5 years
Primary Transplantation-free survival Survival after 5 years without undergoing heart transplantation 5 years
Secondary Changes in left ventricular ejection fraction 5 years
Secondary Changes in left ventricular dimensions 5 years
Secondary Changes in left ventricular diastolic function 5 years
Secondary Changes in right ventricular function 5 years
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