J 2018

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

JADCZYK, Tomasz, Joanna CIOSEK, Aleksandra MICHALEWSKA-WLUDARCZYK, Wojciech SZOT, Zofia PARMA et. al.

Basic information

Original name

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 (616 Poland), Joanna CIOSEK (616 Poland), Aleksandra MICHALEWSKA-WLUDARCZYK (616 Poland), Wojciech SZOT (616 Poland), Zofia PARMA (616 Poland), Beata OCHALA (616 Poland), Miroslaw MARKIEWICZ (616 Poland), Wojciech RYCHLIK (616 Poland), Magdalena KOSTKIEWICZ (616 Poland), Katarzyna GRUSZCZYNSKA (616 Poland), Anna BLACH (616 Poland), Monika DZIERZAK-MIETLA (616 Poland), Lukasz RZESZUTKO (616 Poland), Lukasz PARTYKA (616 Poland), Wojciech ZASADA (616 Poland), Grzegorz SMOLKA (616 Poland), Tomasz PAWLOWSKI (616 Poland), Marek JEDRZEJEK (616 Poland), Zdeněk STÁREK (203 Czech Republic, belonging to the institution), Krzysztof PLENS (616 Poland), Andrzej OCHALA (616 Poland), Michal TENDERA (616 Poland) and Wojciech WOJAKOWSKI (616 Poland, guarantor)

Edition

CARDIOLOGY JOURNAL, GDANSK, VIA MEDICA, 2018, 1897-5593

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30201 Cardiac and Cardiovascular systems

Country of publisher

Poland

Confidentiality degree

není předmětem státního či obchodního tajemství

Impact factor

Impact factor: 1.743

RIV identification code

RIV/00216224:14110/18:00104169

Organization unit

Faculty of Medicine

UT WoS

000444545500011

Keywords in English

quality of life; refractory angina; bone marrow; cell therapy; CD133 cells

Tags

Tags

International impact, Reviewed
Změněno: 9/2/2019 22:35, Soňa Böhmová

Abstract

V originále

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.