Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy

ConditionCardiomyopathy, Dilated

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-65

SponsorUniversity Medical Centre Ljubljana

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with acute multi-organ failure or a history of hematologic neoplasms were not included.

Trial population

All patients enrolled in clinical trials of stem cell therapy in non-ischemic dilated cardiomyopathy at UMC Ljubljana from January, 2005 will be enrolled.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Autologous stem cell therapy
Biological/Vaccine
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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

Transplantation-free survival

Survival after 5 years without undergoing heart transplantation

Time frame

5 years

Secondary outcomes

Changes in left ventricular ejection fraction

Time frame

5 years

Changes in left ventricular dimensions

Time frame

5 years

Changes in left ventricular diastolic function

Time frame

5 years

Changes in right ventricular function

Time frame

5 years

Other outcomes

Changes in exercise capacity

Time frame

5 years

Changes in NT-proBNP

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medical Centre Ljubljana

Lead sponsor

Source ClinicalTrials.gov

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