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21. Effect of allogeneic adipose tissue‐derived mesenchymal stromal cell treatment in chronic ischaemic heart failure with reduced ejection fraction – the SCIENCE trial.

Author

Qayyum, Abbas Ali, van Klarenbosch, Bas, Frljak, Sabina, Cerar, Andraz, Poglajen, Gregor, Traxler‐Weidenauer, Denise, Nadrowski, Pawel, Paitazoglou, Christina, Vrtovec, Bojan, Bergmann, Martin W., Chamuleau, Steven A. J., Wojakowski, Wojtek, Gyöngyösi, Mariann, Kraaijeveld, Adriaan, Hansen, Kristian Schultz, Vrangbæk, Karsten, Jørgensen, Erik, Helqvist, Steffen, Joshi, Francis Richard, and Johansen, Ellen Mønsted

Subjects
BRAIN natriuretic factor, STROMAL cells, HEART failure, VENTRICULAR ejection fraction, ADIPOSE tissue diseases, CARDIAC patients
Abstract

Aims: The aim of the SCIENCE trial was to investigate whether a single treatment with direct intramyocardial injections of adipose tissue‐derived mesenchymal stromal cells (CSCC_ASCs) was safe and improved cardiac function in patients with chronic ischaemic heart failure with reduced ejection fraction (HFrEF). Methods and results: The study was a European multicentre, double‐blind, placebo‐controlled phase II trial using allogeneic CSCC_ASCs from healthy donors or placebo (2:1 randomization). Main inclusion criteria were New York Heart Association (NYHA) class II–III, left ventricular ejection fraction (LVEF) <45%, and N‐terminal pro‐B‐type natriuretic peptide (NT‐proBNP) levels >300 pg/ml. CSCC_ASCs or placebo (isotonic saline) were injected directly into viable myocardium. The primary endpoint was change in left ventricular end‐systolic volume (LVESV) at 6‐month follow‐up measured by echocardiography. A total of 133 symptomatic HFrEF patients were included. The treatment was safe without any drug‐related severe adverse events or difference in cardiac‐related adverse events during a 3‐year follow‐up period. There were no significant differences between groups during follow‐up in LVESV (0.3 ± 5.0 ml, p = 0.945), nor in secondary endpoints of left ventricular end‐diastolic volume (−2.0 ± 6.0 ml, p = 0.736) and LVEF (−1.6 ± 1.0%, p = 0.119). The NYHA class improved slightly within the first year in both groups without any difference between groups. There were no changes in 6‐min walk test, NT‐proBNP, C‐reactive protein or quality of life the first year in any groups. Conclusion: The SCIENCE trial demonstrated safety of intramyocardial allogeneic CSCC_ASC therapy in patients with chronic HFrEF. However, it was not possible to improve the pre‐defined endpoints and induce restoration of cardiac function or clinical symptoms. [ABSTRACT FROM AUTHOR]

Published
2023
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36. Transendocardial CD34 + Cell Therapy Improves Local Mechanical Dyssynchrony in Patients With Nonischemic Dilated Cardiomyopathy.

Author

Žorž, Neža, Poglajen, Gregor, Frljak, Sabina, Knezevič, Ivan, and Vrtovec, Bojan

Subjects
DILATED cardiomyopathy, CELLULAR therapy, BRAIN natriuretic factor, CD34 antigen, VENTRICULAR ejection fraction
Abstract

We investigated the effects of cell therapy on local mechanical dyssynchrony (LMD) in patients with nonischemic dilated cardiomyopathy (NICM). We analyzed electromechanical data of 30 NICM patients undergoing CD34+ cell transplantation. All patients underwent bone marrow stimulation; CD34+ cells were collected by apheresis and injected transendocardially. At baseline and at 6 months after therapy, we performed electromechanical mapping and measured unipolar voltage (UV) and LMD at cell injection sites. LMD was defined as a temporal difference between global and segmental peak systolic displacement normalized to the average duration of the RR interval. Favorable clinical response was defined as increase in the left ventricular ejection fraction (LVEF) ≥5% between baseline and 6 months. Using paired electromechanical point-by-point analysis, we were able to identify 233 sites of CD34+ cell injections in 30 patients. We found no overall differences in local UV between baseline and 6 months (10.7 ± 4.1 mV vs 10.0 ± 3.6 mV, P = 0.42). In contrast, LMD decreased significantly (17 ± 17% at baseline vs 13 ± 12% at 6 months, P = 0.00007). Favorable clinical response at 6 months was found in 19 (63%) patients (group A), and 11 (37%) patients did not respond to cell therapy (group B). At baseline, the two groups did not differ in age, gender, LVEF, or N terminal-pro brain natriuretic peptide (NT-proBNP) levels. Similarly, we found no differences in baseline UV (9.5 ± 2.9 mV in group A vs 8.6 ± 2.4 mV in group B, P = 0.41) or LMD at cell injection sites (17 ± 19% vs 16 ± 14%, P = 0.64). In contrast, at 6 months, we found higher UV in group A (10.0 ± 3.1 mV vs 7.4 ± 1.9 mV in group B, P = 0.04). Furthermore, when compared with group B, patients in group A displayed a significantly lower LMD (11 ± 12% vs 16 ± 10%, P = 0.002). Thus, it appears that favorable clinical effects of cell therapy in NICM patients may be associated with a decrease of LMD at cell injection sites. [ABSTRACT FROM AUTHOR]

Published
2022
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41. EFFECTS OF CD34+ STEM CELL TRANSPLANTATION ON RIGHT VENTRICULAR FUNCTION IN PATIENTS WITH NONISCHEMIC DILATED CARDIOMYOPATHY

Author

Frljak, Sabina and Vrtovec, Bojan

Subjects
Heart Failure, CD 34+ Cells, Dilated Cardiomyopathy, dilatativna kardiomiopatija, CD 34+ matične celice, funkcija desnega prekata, srčno popuščanje, Right Ventricular Function
Abstract

Aims. Contraction of interventricular septum (IVS) represents an important component of right ventricular (RV) function. We investigated the effects of transendocardial delivery of CD34+ cells into IVS on RV function in patients with non-ischemic dilated cardiomyopathy (DCM). Methods. We enrolled 80 patients with non-ischemic DCM, NYHA functional class 3 and LVEF

Published
2018

42. Stem Cell Therapy in Patients with Chronic Nonischemic Heart Failure

Author

Poglajen, Gregor, Zemljič, Gregor, Frljak, Sabina, Cerar, Andraž, Andročec, Vesna, Sever, Matjaž, and Černelč, Peter

Subjects
Article Subject
Abstract

Aim of the Review. The aim of this review is to discuss recent advances in clinical aspects of stem cell therapy in chronic nonischemic heart failure (DCMP) with emphasis on patient selection, stem cell types, and delivery methods. Recent Findings. Several stem cell types have been considered for the treatment of DCMP patients. Bone marrow-derived cells and CD34+ cells have been demonstrated to improve myocardial performance, functional capacity, and neurohumoral activation. Furthermore, allogeneic mesenchymal stem cells were also shown to be effective in improving heart function in this patient population; this may represent an important step towards the development of a standardized stem cell product for widespread clinical use in patients with DCMP. Summary. The trials of stem cell therapy in DCMP patients have shown some promising results, thus making DCMP apparently more inviting target for stem cell therapy than chronic ischemic heart failure, where studies to date failed to demonstrate a consistent effect of stem cells on myocardial performance. Future stem cell strategies should aim for more personalized therapeutic approach by establishing the optimal stem cell type or their combination, dose, and delivery method for an individual patient adjusted for patient’s age and stage of the disease.

Published
2018
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