open access

Vol 25, No 4 (2018)
Original articles — Clinical cardiology
Published online: 2018-09-12
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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

Tomasz Jadczyk, Joanna Ciosek, Aleksandra Michalewska-Wludarczyk, Wojciech Szot, Zofia Parma, Beata Ochala, Miroslaw Markiewicz, Wojciech Rychlik, Magdalena Kostkiewicz, Katarzyna Gruszczynska, Anna Blach, Monika Dzierzak-Mietla, Lukasz Rzeszutko, Lukasz Partyka, Wojciech Zasada, Grzegorz Smolka, Tomasz Pawlowski, Marek Jedrzejek, Zdenek Starek, Krzysztof Plens, Andrzej Ochala, Michal Tendera, Wojciech Wojakowski
DOI: 10.5603/CJ.2018.0082
·
Pubmed: 30211929
·
Cardiol J 2018;25(4):521-529.

open access

Vol 25, No 4 (2018)
Original articles — Clinical cardiology
Published online: 2018-09-12

Abstract

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.

Abstract

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.

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Keywords

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

About this article
Title

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

Journal

Cardiology Journal

Issue

Vol 25, No 4 (2018)

Pages

521-529

Published online

2018-09-12

DOI

10.5603/CJ.2018.0082

Pubmed

30211929

Bibliographic record

Cardiol J 2018;25(4):521-529.

Keywords

quality of life
refractory angina
bone marrow
cell therapy
CD133 cells

Authors

Tomasz Jadczyk
Joanna Ciosek
Aleksandra Michalewska-Wludarczyk
Wojciech Szot
Zofia Parma
Beata Ochala
Miroslaw Markiewicz
Wojciech Rychlik
Magdalena Kostkiewicz
Katarzyna Gruszczynska
Anna Blach
Monika Dzierzak-Mietla
Lukasz Rzeszutko
Lukasz Partyka
Wojciech Zasada
Grzegorz Smolka
Tomasz Pawlowski
Marek Jedrzejek
Zdenek Starek
Krzysztof Plens
Andrzej Ochala
Michal Tendera
Wojciech Wojakowski

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