Skeletal muscle-derived cell implantation for the treatment of sphincter-related faecal incontinence.
Skeletal muscle-derived cell implantation for the treatment of sphincter-related faecal incontinence.
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DOI：
10.1186/s13287-018-0978-y
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发表时间：
2018-09-13
影响因子：
7.5
通讯作者：
Thurner M
中科院分区：
文献类型：
--
作者：
Frudinger A;Marksteiner R;Pfeifer J;Margreiter E;Paede J;Thurner M
在早期的试点研究与10名妇女，我们调查了一种新的方法来治疗大便失禁（FI）由于产科创伤，涉及超声引导下注射自体骨骼肌来源的细胞（SMDC）到肛门外括约肌（EAS），并观察到显着的改善。在当前的研究中，我们在扩展的患者组中测试了这种治疗方法：由于EAS损伤和/或萎缩而患有FI的男性和女性患者。此外，评估了较低细胞计数和冷冻保存SMDC的可行性。在这项单中心、探索性、基线对照临床试验中，每例患者（n = 39;平均年龄60.6 ± 13.81岁）接受了79.4 ± 22.5 × 106个冷冻保存的自体SMDC。评价了FI参数、粪便失禁生活质量（FIQL）、肛门直肠测压和植入后1、6和12个月从基线的安全性变化。本试验中使用的SMDC含有高百分比的肌原性表达（CD 56+）和肌肉干细胞标志物表达（Pax 7+，Myf 5+）细胞。干预耐受性良好，无任何严重不良事件。12个月后，每周尿失禁发作次数（WIE，主要变量）、FIQL和患者状况显著改善。在80.6%的男性和78.4%的女性中，WIE频率至少降低了50%; Wexner评分和FI投诉的严重程度显著降低，与性别和FI原因无关。在男性和女性中，将SMDC注射到EAS中有效地改善了由于EAS损伤和/或萎缩引起的括约肌相关FI。当在更大的安慰剂对照试验中得到证实时，这种微创手术有可能成为FI的一线治疗。欧盟临床试验注册中心，EudraCT 2010-023826-19（注册日期：2010年11月8日）。
In an earlier pilot study with 10 women, we investigated a new approach for therapy of faecal incontinence (FI) due to obstetric trauma, involving ultrasound-guided injection of autologous skeletal muscle-derived cells (SMDC) into the external anal sphincter (EAS), and observed significant improvement. In the current study, we tested this therapeutic approach in an extended patient group: male and female patients suffering from FI due to EAS damage and/or atrophy. Furthermore, feasibility of lower cell counts and cryo-preserved SMDC was assessed. In this single-centre, explorative, baseline-controlled clinical trial, each patient (n = 39; mean age 60.6 ± 13.81 years) received 79.4 ± 22.5 × 106 cryo-preserved autologous SMDC. Changes in FI parameters, Fecal Incontinence Quality of Life (FIQL), anorectal manometry and safety from baseline to 1, 6 and 12 months post implantation were evaluated. SMDC used in this trial contained a high percentage of myogenic-expressing (CD56+) and muscle stem cell marker-expressing (Pax7+, Myf5+) cells. Intervention was well tolerated without any serious adverse events. After 12 months, the number of weekly incontinence episodes (WIE, primary variable), FIQL and patient condition had improved significantly. In 80.6% of males and 78.4% of females, the WIE frequency decreased by at least 50%; Wexner scores and severity of FI complaints decreased significantly, independent of gender and cause of FI. Injection of SMDCs into the EAS effectively improved sphincter-related FI due to EAS damage and/or atrophy in males and females. When confirmed in a larger, placebo-controlled trial, this minimal invasive procedure has the potential to become first-line therapy for FI. EU Clinical Trials Register, EudraCT 2010-023826-19 (Date of registration: 08.11.2010).
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影响因子：
3.4
作者：
Frudinger, A.;Pfeifer, J.;Halligan, S.
通讯作者：
Halligan, S.
影响因子：
4.4
作者：
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通讯作者：
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影响因子：
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影响因子：
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作者：
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通讯作者：
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影响因子：
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作者：
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