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

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.

Základní údaje

Originální název

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

Autoři

JADCZYK, Tomasz (616 Polsko), Joanna CIOSEK (616 Polsko), Aleksandra MICHALEWSKA-WLUDARCZYK (616 Polsko), Wojciech SZOT (616 Polsko), Zofia PARMA (616 Polsko), Beata OCHALA (616 Polsko), Miroslaw MARKIEWICZ (616 Polsko), Wojciech RYCHLIK (616 Polsko), Magdalena KOSTKIEWICZ (616 Polsko), Katarzyna GRUSZCZYNSKA (616 Polsko), Anna BLACH (616 Polsko), Monika DZIERZAK-MIETLA (616 Polsko), Lukasz RZESZUTKO (616 Polsko), Lukasz PARTYKA (616 Polsko), Wojciech ZASADA (616 Polsko), Grzegorz SMOLKA (616 Polsko), Tomasz PAWLOWSKI (616 Polsko), Marek JEDRZEJEK (616 Polsko), Zdeněk STÁREK (203 Česká republika, domácí), Krzysztof PLENS (616 Polsko), Andrzej OCHALA (616 Polsko), Michal TENDERA (616 Polsko) a Wojciech WOJAKOWSKI (616 Polsko, garant)

Vydání

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

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30201 Cardiac and Cardiovascular systems

Stát vydavatele

Polsko

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 1.743

Kód RIV

RIV/00216224:14110/18:00104169

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.5603/CJ.2018.0082

UT WoS

000444545500011

Klíčová slova anglicky

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

Štítky

14110115, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 9. 2. 2019 22:35, Soňa Böhmová

Anotace

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.

Citovat

JADCZYK, Tomasz, 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, Zdeněk STÁREK, Krzysztof PLENS, Andrzej OCHALA, Michal TENDERA a Wojciech WOJAKOWSKI. 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. CARDIOLOGY JOURNAL. GDANSK: VIA MEDICA, 2018, roč. 25, č. 4, s. 521-529. ISSN 1897-5593. Dostupné z: https://dx.doi.org/10.5603/CJ.2018.0082.

@article{1454578,
   author = {Jadczyk, Tomasz and Ciosek, Joanna and MichalewskaandWludarczyk, Aleksandra and Szot, Wojciech and Parma, Zofia and Ochala, Beata and Markiewicz, Miroslaw and Rychlik, Wojciech and Kostkiewicz, Magdalena and Gruszczynska, Katarzyna and Blach, Anna and DzierzakandMietla, Monika and Rzeszutko, Lukasz and Partyka, Lukasz and Zasada, Wojciech and Smolka, Grzegorz and Pawlowski, Tomasz and Jedrzejek, Marek and Stárek, Zdeněk and Plens, Krzysztof and Ochala, Andrzej and Tendera, Michal and Wojakowski, Wojciech},
   article_location = {GDANSK},
   article_number = {4},
   doi = {http://dx.doi.org/10.5603/CJ.2018.0082},
   keywords = {quality of life; refractory angina; bone marrow; cell therapy; CD133 cells},
   language = {eng},
   issn = {1897-5593},
   journal = {CARDIOLOGY JOURNAL},
   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},
   volume = {25},
   year = {2018}
}

TY  - JOUR
ID  - 1454578
AU  - 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
PY  - 2018
TI  - 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
JF  - CARDIOLOGY JOURNAL
VL  - 25
IS  - 4
SP  - 521-529
EP  - 521-529
PB  - VIA MEDICA
SN  - 18975593
KW  - quality of life
KW  - refractory angina
KW  - bone marrow
KW  - cell therapy
KW  - CD133 cells
N2  - 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.
ER  -

JADCZYK, Tomasz, 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, Zdeněk STÁREK, Krzysztof PLENS, Andrzej OCHALA, Michal TENDERA a Wojciech WOJAKOWSKI. 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. \textit{CARDIOLOGY JOURNAL}. GDANSK: VIA MEDICA, 2018, roč.~25, č.~4, s.~521-529. ISSN~1897-5593. Dostupné z: https://dx.doi.org/10.5603/CJ.2018.0082.

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