Autologous Muscle Derived Cell Therapy for Stress Urinary Incontinence: A Prospective, Dose Ranging Study
Autologous Muscle Derived Cell Therapy for Stress Urinary Incontinence: A Prospective, Dose Ranging Study
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DOI：
10.1016/j.juro.2012.09.028
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发表时间：
2013-02-01
影响因子：
6.6
通讯作者：
Chancellort, Michael B.
中科院分区：
文献类型：
--
作者：
Carr, Lesley K.;Robert, Magali;Chancellort, Michael B.
目的：在这项可行性研究中，我们评估了自体肌源性细胞的12个月安全性和潜在疗效。（Cook MyoSite Incorporated，Pittsburgh，Pennsylvania）作为压力性尿失禁的疗法。共有38名妇女，其中压力性尿失禁经保守治疗12个月或更长时间没有改善，接受了低剂量的括约肌内注射（1、2、4、8或16 × 10（6））或高剂量（32、64或128 × 10（6））的自体肌肉衍生细胞，其来源于其股四头肌的活组织检查。随访3个月后，所有患者均可选择相同剂量的第二次治疗。在末次治疗后1、3、6和12个月进行评估。主要终点是不良事件的发生率和严重程度。此外，压力性尿失禁的严重程度的变化进行了评估垫测试，日记的失禁发作和生活quality of life surveillance.Results：在38例患者中，33完成了研究。治疗相关并发症仅限于轻微事件，如活检和注射部位疼痛/瘀伤。在有资格进行分析的接受2次自体肌源性细胞治疗的患者中，与低剂量组相比，高剂量组中更高百分比的患者经历了50%或更多的衬垫重量减轻。（88.9%，8/9 vs 61.5%，8/13），日记报告的应力漏减少50%或更多（77.8%，7/9 vs 53.3%，8/15），3天内发生0 - 1次泄漏（88.9%，8/9 vs 33.3%，5/15）。以广泛的剂量注射自体肌源性细胞似乎是安全的，没有报告与治疗相关的重大不良事件。此外，自体肌肉衍生细胞治疗有望缓解压力性尿失禁症状并提高生活质量。
Purpose: In this feasibility study we assessed the 12-month safety and potential efficacy of autologous muscle derived cells (Cook MyoSite Incorporated, Pittsburgh, Pennsylvania) as therapy for stress urinary incontinence.Materials and Methods: A total of 38 women in whom stress urinary incontinence had not improved with conservative therapy for 12 or more months underwent intrasphincter injection of low doses (1, 2, 4, 8 or 16 x 10(6)) or high doses (32, 64 or 128 x 10(6)) of autologous muscle derived cells, which were derived from biopsies of their quadriceps femoris. All patients could elect a second treatment of the same dose after 3-month followup. Assessments were made at 1, 3, 6 and 12 months after the last treatment. The primary end point was the incidence and severity of adverse events. In addition, changes in stress urinary incontinence severity were evaluated by pad test, diary of incontinence episodes and quality of life surveys.Results: Of the 38 patients 33 completed the study. Treatment related complications were limited to minor events such as pain/bruising at the biopsy and injection sites. Of patients who received 2 treatments of autologous muscle derived cells who were eligible for analysis, a higher percentage of those in the high dose vs the low dose group experienced a 50% or greater reduction in pad weight (88.9%, 8 of 9 vs 61.5%, 8 of 13), had a 50% or greater reduction in diary reported stress leaks (77.8%, 7 of 9 vs 53.3%, 8 of 15) and had 0 to 1 leaks during 3 days (88.9%, 8 of 9 vs 33.3%, 5 of 15) at final followup.Conclusions: Injection of autologous muscle derived cells in a wide range of doses appears safe with no major treatment related adverse events reported. In addition, treatment with autologous muscle derived cells shows promise for relieving stress urinary incontinence symptoms and improving quality of life.