Sarveazad Arash, Newstead Graham L, Mirzaei Rezvan, Joghataei Mohammad Taghi, Bakhtiari Mehrdad, Babahajian Asrin, Mahjoubi Bahar
Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran.
Sydney Colorectal Associates, Prince of Wales Hospital, Randswick, NSW, Australia.
Stem Cell Res Ther. 2017 Feb 21;8(1):40. doi: 10.1186/s13287-017-0489-2.
Anal sphincter defects are a major cause of fecal incontinence causing negative effects on daily life, social interactions, and mental health. Because human adipose-derived stromal/stem cells (hADSCs) are easier and safer to access, secrete high levels of growth factor, and have the potential to differentiate into muscle cells, we investigated the ability of hADSCs to improve anal sphincter incontinence.
The present randomized double-blind clinical trial was performed on patients with sphincter defects. They were categorized into a cell group (n = 9) and a control group (n = 9). Either 6 × 10 hADSCs per 3 ml suspended in phosphate buffer saline (treatment) or 3 ml phosphate buffer saline (placebo) was injected. Two months after surgery, the Wexner score, endorectal sonography, and electromyography (EMG) results were recorded.
Comparing Wexner scores in the cell group and the control group showed no significant difference. In our EMG and endorectal sonography analysis using ImageJ/Fiji 1.46 software, the ratio of the area occupied by the muscle to total area of the lesion showed a 7.91% increase in the cell group compared with the control group.
The results of the current study show that injection of hADSCs during repair surgery for fecal incontinence may cause replacement of fibrous tissue, which acts as a mechanical support to muscle tissue with contractile function. This is a key point in treatment of fecal incontinence especially in the long term and may be a major step forward.
Iranian Registry of Clinical Trials IRCT2016022826316N2 . Retrospectively registered 7 May 2016.
肛门括约肌缺陷是大便失禁的主要原因，会对日常生活、社交互动和心理健康产生负面影响。由于人脂肪来源的基质/干细胞（hADSCs）获取更容易、更安全，能分泌高水平生长因子，且有分化为肌肉细胞的潜力，我们研究了hADSCs改善肛门括约肌失禁的能力。
本随机双盲临床试验针对括约肌缺陷患者开展。他们被分为细胞组（n = 9）和对照组（n = 9）。分别注射每3毫升悬浮于磷酸盐缓冲盐水中的6×10 hADSCs（治疗组）或3毫升磷酸盐缓冲盐水（安慰剂组）。术后两个月，记录韦克斯纳评分、直肠内超声检查和肌电图（EMG）结果。
比较细胞组和对照组的韦克斯纳评分，未发现显著差异。在我们使用ImageJ/Fiji 1.46软件进行的肌电图和直肠内超声检查分析中，与对照组相比，细胞组中肌肉所占面积与病变总面积的比值增加了7.91%。
当前研究结果表明，在大便失禁修复手术期间注射hADSCs可能会导致纤维组织被替代，纤维组织可作为具有收缩功能的肌肉组织的机械支撑。这是治疗大便失禁尤其是长期治疗的关键点，可能是向前迈出的重要一步。
伊朗临床试验注册中心IRCT2016022826316N2。2016年5月7日追溯注册。
