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Projects / Programmes source: ARIS

Precision Medicine Approach to Cell Therapy in Heart Failure

Research activity

Code Science Field Subfield
3.06.00  Medical sciences  Cardiovascular system   

Code Science Field
3.02  Medical and Health Sciences  Clinical medicine 
Keywords
stem cells; heart failure; precision medicine
Evaluation (rules)
source: COBISS
Points
6,270.56
A''
1,007.69
A'
2,034.48
A1/2
3,115.29
CI10
8,570
CImax
1,728
h10
38
A1
19.47
A3
13.57
Data for the last 5 years (citations for the last 10 years) on September 30, 2023; A3 for period 2017-2021
Data for ARIS tenders ( 04.04.2019 – Programme tender, archive )
Database Linked records Citations Pure citations Average pure citations
WoS  425  8,277  7,724  18.17 
Scopus  445  10,747  10,007  22.49 
Researchers (12)
no. Code Name and surname Research area Role Period No. of publicationsNo. of publications
1.  32516  Vesna Andročec    Technical associate  2021 - 2023  58 
2.  37394  Andraž Cerar  Cardiovascular system  Researcher  2021 - 2023  135 
3.  31049  PhD Erik Dovgan  Computer science and informatics  Researcher  2021 - 2023  140 
4.  24039  PhD Sabina Frljak  Cardiovascular system  Researcher  2021 - 2023  114 
5.  08501  PhD Matjaž Gams  Computer science and informatics  Researcher  2021 - 2023  1,649 
6.  29523  PhD Anton Gradišek  Physics  Researcher  2021 - 2023  416 
7.  32517  PhD Renata Okrajšek  Cardiovascular system  Researcher  2021 - 2023  101 
8.  28021  PhD Gregor Poglajen  Cardiovascular system  Researcher  2021 - 2023  326 
9.  19345  PhD Miran Šebeštjen  Cardiovascular system  Researcher  2021 - 2023  260 
10.  18826  PhD Bojan Vrtovec  Medical sciences  Head  2021 - 2023  481 
11.  37784  PhD Gregor Zemljič  Medical sciences  Researcher  2021 - 2023  121 
12.  54242  Neža Žorž  Cardiovascular system  Researcher  2021 - 2023  18 
Organisations (2)
no. Code Research organisation City Registration number No. of publicationsNo. of publications
1.  0106  Jožef Stefan Institute  Ljubljana  5051606000  87,243 
2.  0312  University Medical Centre Ljubljana  Ljubljana  5057272000  74,815 
Abstract
Background. Despite significant advances in medical and device therapy over the past decades, chronic heart failure represents an increasingly common and debilitating disorder with poor prognosis and high early and late mortality rates. Although the accumulated clinical evidence suggests that cell therapy may be beneficial in different subpopulations of heart failure patients, the results of clinical trials are inconsistent, which makes it difficult to translate the research findings into everyday clinical practice. Objectives. The overall goal of the project is to develop a personalized cell therapy approach to be used as a standard clinical management in a broad population of patients with chronic heart failure. Specifically, the primary objective of the project is to define optimal patient selection criteria, and the secondary objective is to better define the effects of cell dose, cell type, and cell delivery techniques on the efficacy of cell therapy. Methods. The work plan consists of 2WPs. In WP1 we plan to analyze the combined dataset from 6 previous clinical trials conducted by our research group, enrolling patients with chronic heart failure who were treated with cell therapy. By implementation of artificial intelligence analysis on this dataset we aim to define individual patient profiles that will most likely benefit from cell therapy. Artificial intelligence analysis will be based on the analysis of the patient Holistic Health Records. Classification models and clustering models to assess how patients respond to treatment will be based on classical machine learning and various types of neural networks. Patient responder profiles derived in WP1 will then be validated in a prospective randomized clinical trial in WP2. The study protocol will consist of a prospective, randomized double blind, placebo-controlled design. We will enroll 30 patients with heart failure. After enrollment, all patients will receive 5-day stem cell mobilization with G-CSF. Thereafter, patients will be randomly allocated to either active (SC Group) or control group (Controls) in a 2:1 ratio. Patients in the SC Group will undergo apheresis; CD34+ cells will be collected with immunomagnetic selection, and delivered transendocardialy in the target areas defined by electroanatomical mapping. In the Controls, no apheresis or immunomagnetic selection of CD34+ cells will be performed; the patients will receive transendocardial injections of placebo using the same electroanatomical mapping protocol as in patients from the SC Group. Patients will be followed for 1 year. At baseline, at 6 months, and at 1 year we will perform comprehensive patient evaluation. All data on patient evaluation will be transferred to a secure central database and will be analyzed using an integration algorithm at the end of the follow-up period. Expected Results. We expect that the results of the project will yield important data on patient selection, stem cell type and dose, and cell delivery techniques, which will optimize the efficacy of cell therapy in chronic heart failure. Based on these data, we will design a web-based application, which will serve as a tool to help physicians to select optimal patients for cell therapy in everyday clinical settings.
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