Haahr Martha Kirstine, Harken Jensen Charlotte, Toyserkani Navid Mohamadpour, Andersen Ditte Caroline, Damkier Per, Sørensen Jens Ahm, Sheikh Søren Paludan, Lund Lars
Department of Urology, Odense University Hospital, Odense, Denmark; The Danish Centre for Regenerative Medicine (www.danishcrm.com), Odense University Hospital, Odense, Denmark; Clinical Institute, University of Southern Denmark, Odense, Denmark.
Laboratory of Molecular and Cellular Cardiology, Department of Clinical Biochemistry and Pharmacology, Odense University Hospital, Odense, Denmark.
Urology. 2018 Nov;121:203.e6-203.e13. doi: 10.1016/j.urology.2018.06.018. Epub 2018 Jun 27.
To explore safety in adipose-derived regenerative cells (ADRC) therapy, treating erectile dysfunction (ED).
Twenty-one patients with ED after radical prostatectomy, with no signs of recovery using conventional therapy, received a single intracavernous injection of autologous ADRC and were followed for 1 year. Six men were incontinent, and 15 were continent at inclusion. The primary (safety of ADRC therapy) and secondary endpoints (sexual function) were evaluated at 1, 3, 6, and 12 months after ADRC injection by registration of adverse events and validated questionnaires using the international index of erectile function-5 and erection hardness score.
No serious adverse events occurred, but 8 reversible minor events related to the liposuction were noted. Eight out of 15 (53%) patients in the continent group reported erectile function sufficient for intercourse at 12 months. Baseline median international index of erectile function-5 scores (6.0; interquartile range [IQR] 3) were unchanged 1 month after the treatment, but significantly increased after 6 to 7 (IQR 17). This effect was sustained at 12 months (median 8; IQR 14). We did not see any improvements in erectile function in the group of incontinent men or among men with ED prior to radical prostatectomy.
Intracavernous injection of ADRC is safe in this phase 1 study with a 12-month follow-up.
探讨脂肪源性再生细胞（ADRC）治疗勃起功能障碍（ED）的安全性。
21例前列腺癌根治术后出现ED且常规治疗无恢复迹象的患者，接受了一次海绵体内自体ADRC注射，并随访1年。纳入时6例患者存在尿失禁，15例患者控尿。在ADRC注射后1、3、6和12个月，通过记录不良事件并使用国际勃起功能指数-5和勃起硬度评分的有效问卷，评估主要终点（ADRC治疗的安全性）和次要终点（性功能）。
未发生严重不良事件，但记录到8例与抽脂相关的可逆性轻微事件。控尿组15例患者中有8例（53%）在12个月时报告勃起功能足以进行性交。治疗后1个月，基线国际勃起功能指数-5评分中位数（6.0；四分位间距[IQR]3）未改变，但在6至7个月后显著升高（IQR 17）。这种效果在12个月时持续存在（中位数8；IQR 14）。在尿失禁男性组或前列腺癌根治术前患有ED的男性中，我们未观察到勃起功能有任何改善。
在这项为期12个月随访的1期研究中，海绵体内注射ADRC是安全的。
