Publication details

Effects of trans-endocardial delivery of bone marrow-derived CD133+cells on angina and quality of life in patients with refractory angina: A sub-analysis of the REGENT-VSEL trial

Authors	JADCZYK Tomasz CIOSEK Joanna MICHALEWSKA-WLUDARCZYK Aleksandra SZOT Wojciech PARMA Zofia OCHALA Beata MARKIEWICZ Miroslaw RYCHLIK Wojciech KOSTKIEWICZ Magdalena GRUSZCZYNSKA Katarzyna BLACH Anna DZIERZAK-MIETLA Monika RZESZUTKO Lukasz PARTYKA Lukasz ZASADA Wojciech SMOLKA Grzegorz PAWLOWSKI Tomasz JEDRZEJEK Marek STÁREK Zdeněk PLENS Krzysztof OCHALA Andrzej TENDERA Michal WOJAKOWSKI Wojciech
Year of publication	2018
Type	Article in Periodical
Magazine / Source	CARDIOLOGY JOURNAL
MU Faculty or unit	Faculty of Medicine
Citation
Doi	http://dx.doi.org/10.5603/CJ.2018.0082
Keywords	quality of life; refractory angina; bone marrow; cell therapy; CD133 cells
Description	Background:The REGENT-VSEL trial demonstrated a neutral effect of transendocardial injection of autologous bone marrow (BM)-derived CD133+ in regard to myocardial ischemia. The current sub-analysis of the REGENT VSEL trial aims to assess the effect stem cell therapy has on quality of life (QoL) in patients with refractory angina. Methods:Thirty-one patients (63.0 +/- 6.4 years, 70% male) with recurrent CCS II-IV angina, despite optimal medical therapy, enrolled in the REGENT-VSEL single center, randomized, double-blinded, and placebo-controlled trial. Of the 31 patients, 16 individuals were randomly assigned to the active stem cell group and 15 individuals were randomly assigned to the placebo group on a 1:1 basis. The inducibility of ischemia, (>= one myocardial segment) was confirmed for each patient using Tc-99m SPECT. QoL was measured using the Seattle Angina Questionnaire. Each patient completed the questionnaire prior to treatment and at the time of their outpatient follow-up visits at 1, 4, 6, and 12 months after cell/placebo treatment. Results:The main finding of the REGENT-VSEL trial sub-analysis was that transendocardial injection of autologous BM-derived CD133+ stem cells in patients with chronic refractory angina did not show significant improvement in QoL in comparison to the control group. Moreover, there was no significant difference between cell therapy and placebo in a number of patients showing improvement of at least 1 Canadian Cardiovascular Society class during the follow-up period. Conclusions:Intra-myocardial delivery of autologous CD133+ stem cells is safe and feasible but does not show a significant improvement in the QoL or angina pectoris symptoms in patients with chronic myocardial ischemia.