Clinical trial NCT02248532: Repetitive Intramyocardial CD34+ Cell Therapy in Dilated Cardiomyopathy (REMEDIUM)
Official title: Repetitive Intramyocardial CD34+ Cell Therapy in Dilated Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dilated Cardiomyopathy
Heart Failure
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of REMEDIUM project is to develop personalized stem cell therapy for patients with chronic heart failure due to dilated cardiomyopathy (DCM). The main focus of the project is (1) on repetitive administration of cell therapy that would allow for long-lasting improvements in heart function and outcome in this patient population. In parallel, the investigators aim to (2) develop a standardized patient-specific stem cell product that could be cryopreserved and stored in a stem cell bank for prolonged time periods, and used for therapeutic application when clinically indicated. By using a unique multimodality imaging platform, the goal of this project is also to (3) define standardized clinical criteria that would serve as a guideline for evaluation of the effects of stem cell therapy in future clinical trials and everyday clinical settings. Finally, to improve the clinical implementation of cell therapy,the investigators aim to (4) develop a stem cell delivery technique that could be used to treat both left and right and ventricular failure and could be implemented in a standardized fashion designed for a widespread clinical use.


Eligibility criteria: Inclusion Criteria:

* Age 18-70 years old
* Diagnosis of DCM according to European Society of Cardiology position statement
* Left ventricular ejection fraction (LVEF) by echocardiography 20-40%,
* New York Heart Association (NYHA) functional class heart failure II or III for at least 3 months before referral.

Exclusion Criteria:

* Acute multi-organ failure
* History of any malignant disease within 5 years
* Diminished functional capacity due to non-cardiac co-morbidities (COPD, PAOD, morbid obesity)
* Pregnancy

Primary outcomes:
measure: Change in left ventricular ejection fraction
timeFrame: baseline and 1 year
Secondary outcomes:
measure: Changes in regional wall motion
timeFrame: baseline and 1 year
measure: Change in left ventricular dimension
timeFrame: 1 year
measure: Change in exercise capacity
timeFrame: baseline and 1 year
measure: Change in NT-proBNP
timeFrame: baseline and 1 year
Other outcomes:
measure: Incidence of ventricular arrhythmias
timeFrame: 1 year
measure: Cardiac mortality
timeFrame: 1 year
measure: Hospitalization for heart failure
timeFrame: 1 year
measure: Pump failure mortality
timeFrame: 1 year
Locations:
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana
state: Please Select
Study officials:
References:
citation: Vrtovec B, Poglajen G, Lezaic L, Sever M, Socan A, Domanovic D, Cernelc P, Torre-Amione G, Haddad F, Wu JC. Comparison of transendocardial and intracoronary CD34+ cell transplantation in patients with nonischemic dilated cardiomyopathy. Circulation. 2013 Sep 10;128(11 Suppl 1):S42-9. doi: 10.1161/CIRCULATIONAHA.112.000230.
citation: Vrtovec B, Poglajen G, Sever M, Zemljic G, Frljak S, Cerar A, Cukjati M, Jaklic M, Cernelc P, Haddad F, Wu JC. Effects of Repetitive Transendocardial CD34+ Cell Transplantation in Patients With Nonischemic Dilated Cardiomyopathy. Circ Res. 2018 Jul 20;123(3):389-396. doi: 10.1161/CIRCRESAHA.117.312170. Epub 2018 Jun 7.
citation: Frljak S, Jaklic M, Zemljic G, Cerar A, Poglajen G, Vrtovec B. CD34+ Cell Transplantation Improves Right Ventricular Function in Patients with Nonischemic Dilated Cardiomyopathy. Stem Cells Transl Med. 2018 Feb;7(2):168-172. doi: 10.1002/sctm.17-0197.
citation: Rozman JZ, Perme MP, Jez M, Malicev E, Krasna M, Novakovic S, Vrtovec B, Rozman P. The effect of CD34+ cell telomere length and hTERT expression on the outcome of autologous CD34+ cell transplantation in patients with chronic heart failure. Mech Ageing Dev. 2017 Sep;166:42-47. doi: 10.1016/j.mad.2017.06.001. Epub 2017 Jun 19.