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 Jadczyk1, Joanna Ciosek1, Aleksandra Michalewska-Wludarczyk1, Wojciech Szot23, Zofia Parma1, Beata Ochala1, Miroslaw Markiewicz4, Wojciech Rychlik5, Magdalena Kostkiewicz6, Katarzyna Gruszczynska7, Anna Blach1, Monika Dzierzak-Mietla4, Lukasz Rzeszutko8, Lukasz Partyka910, Wojciech Zasada89, Grzegorz Smolka1, Tomasz Pawlowski1, Marek Jedrzejek1, Zdenek Starek1112, Krzysztof Plens9, Andrzej Ochala1, Michal Tendera1, Wojciech Wojakowski1
Pubmed: 30211929
Cardiol J 2018;25(4):521-529.


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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