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首页> 外文期刊>Cardiology Journal >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
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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

机译：经心内膜递送骨髓源性CD133 +细胞对难治性心绞痛患者心绞痛和生活质量的影响：REGENT-VSEL试验的亚分析

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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.
机译：背景：REGENT-VSEL试验证明，经心内膜注射自体骨髓（BM）衍生的CD133 +对心肌缺血具有中性作用。 REGENT VSEL试验的当前子分析旨在评估干细胞治疗对难治性心绞痛患者的生活质量（QoL）的影响。方法：REGENT-VSEL单中心，随机，双盲和安慰剂对照试验纳入了31例（63.0±6.4岁，男性占70％）复发性CCS II–IV心绞痛的患者，尽管接受了最佳药物治疗。在这31例患者中，以1：1为基础将16例患者随机分为活性干细胞组，将15例患者随机分为安慰剂组。使用Tc-99m SPECT对每位患者确认了缺血的诱导性（≥一个心肌节段）。使用西雅图心绞痛问卷调查生活质量。每位患者在治疗前和细胞/安慰剂治疗后1、4、6和12个月进行门诊随访时均填写了调查表。结果：REGENT-VSEL试验亚分析的主要发现是，与对照组相比，经心内膜注射自体BM衍生的CD133 +干细胞对慢性难治性心绞痛患者的QoL没有明显改善。此外，在随访期间，在至少显示出至少一种加拿大心血管学会等级改善的许多患者中，细胞疗法与安慰剂之间无显着差异。结论：心肌内自体CD133 +干细胞的心肌内递送是安全可行的，但对于慢性心肌缺血的患者，其QoL或心绞痛症状未见明显改善。

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