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Projects / Programmes source: ARIS

Repetitive Intramyocardial CD34+ Cell Therapy in Dilated Cardiomyopathy (REMEDIUM)

Research activity

Code Science Field Subfield
3.06.00  Medical sciences  Cardiovascular system   

Code Science Field
B530  Biomedical sciences  Cardiovascular system 

Code Science Field
3.02  Medical and Health Sciences  Clinical medicine 
Keywords
Heart failure, Dilated cardiomyopathy, Stem cell therapy
Evaluation (rules)
source: COBISS
Researchers (12)
no. Code Name and surname Research area Role Period No. of publicationsNo. of publications
1.  32516  Vesna Andročec    Technical associate  2016 - 2018  58 
2.  37394  Andraž Cerar  Cardiovascular system  Researcher  2016 - 2018  135 
3.  24039  PhD Sabina Frljak  Cardiovascular system  Researcher  2016 - 2018  114 
4.  32097  PhD Martina Jaklič  Microbiology and immunology  Researcher  2016 - 2018  91 
5.  16344  PhD Borut Kirn  Cardiovascular system  Researcher  2016 - 2018  61 
6.  17708  Regina Klavžar    Technical associate  2018 
7.  17712  MSc Janez Podobnik  Neurobiology  Researcher  2018  60 
8.  28021  PhD Gregor Poglajen  Cardiovascular system  Researcher  2016 - 2018  326 
9.  05201  PhD Nejka Potočnik  Cardiovascular system  Researcher  2016 - 2018  129 
10.  24908  PhD Matjaž Sever  Microbiology and immunology  Researcher  2016 - 2018  268 
11.  18826  PhD Bojan Vrtovec  Medical sciences  Head  2016 - 2018  481 
12.  37784  PhD Gregor Zemljič  Medical sciences  Researcher  2016 - 2018  121 
Organisations (2)
no. Code Research organisation City Registration number No. of publicationsNo. of publications
1.  0312  University Medical Centre Ljubljana  Ljubljana  5057272000  74,860 
2.  0381  University of Ljubljana, Faculty of Medicine  Ljubljana  1627066  45,116 
Abstract
Background. Stem cell therapy appears to represent a safe and effective treatment for patients with heart failure due to dilated cardiomyopathy. Study Aims. The aim of this study is to investigate whether repetitive stem cell application would be associated with superior clinical benefits when compared to single stem cell application in patients with dilated cardiomyopathy. Methods. The REMEDIUM trial will consist of a prospective randomized study design. We plan to enroll 80 patients with dilated cardiomyopathy. All patients will undergo stem cell mobilization; thereafter CD34+ cells will be collected via apheresis. Patients will be randomly allocated in 1:1 ratio in repetitive cell administration (Group A) and single administration (Group B). Group A will receive cell therapy at baseline, and again after 6 months; Group B will only receive one dose of cells at baseline. Before cell administration we will perform detailed electroanatomical mapping of the left ventricle, which will enable us to perform regional and global multimodality assessment of viability, contractility, and electrophysiological properties of the myocardium. The total duration of the follow up will be 1 year. At the time of enrollment, and at 6-month intervals thereafter, we will perform detailed clinical evaluation, echocardiography, high-resolution electrocardiography, 6-minute walk test, and measure plasma levels of NT-proBNP. Magnetic resonance imaging (MRI) will be performed in all eligible patients at baseline, 6 months, and 1 year. Expected results. When compared to single cell administration we expect repetitive cell therapy to be associated with superior effects on myocardial structure and function, laboratory parameters, electro-anatomical parameters, patient exercise capacity and outcome.
Significance for science
The expected impact of REMEDIUM trial will provide important clinical results, which will serve to further define the role of stem cell therapy in the treatment of heart failure and DCM. By combining the clinical and translation aspects, the aim of this trial is to directly implement the existing pre-clinical data into a clinical setting. Futhermore, the experience with already conducted first long-term clinical trial of CD34+ cell therapy in DCM offers a unique advantage over other similar research efforts worldwide, and may serve to significantly improve the international competitiveness of Slovenian regenerative medicine. By combining all of the above, the development of personalized CD34+ cell product that could be stored and used as needed, the REMEDIUM trial could also serve as an important fundament for effective dissemination and exploitation of stem cell therapies.
Significance for the country
The research aspect of REMEDIUM trial will provide important clinical data that could be used to further expand the role of stem cell therapy in patients with DCM. The translational part of the trial will be implemented in close collaboration with the clinical part, and will aim to develop patient-specific CD34+ cell product.   Therefore, the trial also offers a unique business opportunity for both European and global markets through a novel concept of personalized stem cell banking. The aim of this model is to start the initiative to develop a network of stem cell banking facilities, which would serve to store CD34+ cells for patients with different stages of heart failure. If the concept is proven successful, the storage capacity could be further expanded to store CD34+ cells of healthy individuals. This would allow for a unique preventive concept in regenerative medicine: cryopreserved personalized CD34+ cell product of healthy individuals could be stored and used in case of development of heart failure. This would not only allow for treatment of heart failure in earlier stages of the disease, but would also represent a boost for strengthening and growth of companies focusing on stem cell banking and cryopreservation.
Most important scientific results Interim report, final report
Most important socioeconomically and culturally relevant results Final report
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