Results of Use of Tissue-Engineered Autologous Oral Mucosa Graft for Urethral Reconstruction: A Multicenter, Prospective, Observational Trial.
Results of Use of Tissue-Engineered Autologous Oral Mucosa Graft for Urethral Reconstruction: A Multicenter, Prospective, Observational Trial.
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DOI：
10.1016/j.ebiom.2017.08.014
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发表时间：
2017-09
期刊：
影响因子：
11.1
通讯作者：
Knispel H
中科院分区：
文献类型：
--
作者：
Ram-Liebig G;Barbagli G;Heidenreich A;Fahlenkamp D;Romano G;Rebmann U;Standhaft D;van Ahlen H;Schakaki S;Balsmeyer U;Spiegler M;Knispel H
尿道狭窄行尿道成形术的口腔黏膜采集与供区发病率相关。我们评估了在任何病因、位置、长度和严重程度的狭窄复发（真实世界数据）的常规实践中，授权的组织工程化口腔粘膜移植物（TEOMG）的功能和安全性。这项前瞻性、非干预性观察性研究纳入了来自8家临床试验机构的99例具有不同尿道成形术经验水平的患者。主要和次要结局为12个月和24个月时的成功率（SR）和安全性。除1例患者外，所有患者既往接受过≥ 1次手术治疗，77.1%（64/83）≥ 2次，31.3%（26/83）≥ 4次。术前和术后平均± SD峰值流速（Qmax）分别为8.3 ± 4.7 mL/s（n = 57）和25.4 ± 14.7 mL/s（n = 51）。12个月时SR为67.3%（95% CI 57.6-77.0），24个月时为58.2%（95% CI 47.7-68.7）（保守Kaplan Meier评估）。在手术经验较高和较低的情况下，SR范围在85.7%和0%之间。所有中心可评价患者的12个月和24个月SR的简单比例分别为70.8%（46/65）和76.9%（30/39）。除1例患者外，未报告口服不良事件。TEOMG是一种安全有效的尿道成形术。一项前瞻性、多中心、非干预性、独立监测的观察性研究评估了经批准的自体组织工程化口腔粘膜移植物用于尿道成形术的功能和安全性。99例患者入选该研究。自体组织工程化口腔粘膜是尿道重建的安全选择，供区发病率最低，0.5%的男性人群患有尿道狭窄，如果不治疗可能会导致严重的健康问题。尿道的患病部分可以通过手术用健康组织替代。天然口腔粘膜的使用具有良好的治疗成功率;然而，其收获与口腔并发症有关。再生医学已经提出了一种移植物，从病人的一小块口腔粘膜培养。在一项99例患者混合人群的多中心研究中，培养移植物的功能和治疗成功率与常规实践中的天然口腔粘膜相当，供体部位发病率最低。
Harvest of oral mucosa for urethroplasty due to urethral stricture is associated with donor-site-morbidity. We assessed functionality and safety of an authorized tissue-engineered oral mucosa graft (TEOMG) under routine practice in stricture recurrences of any etiology, location, length and severity (real-world data). 99 patients from eight centers with heterogenous urethroplasty experience levels were included in this prospective, non-interventional observational study. Primary and secondary outcomes were success rate (SR) and safety at 12 and 24 months. All but one patient had ≥ 1, 77.1% (64 of 83) ≥ 2 and 31.3% (26 of 83) ≥ 4 previous surgical treatments. Pre- and postoperative mean ± SD peak flow rate (Qmax) were 8.3 ± 4.7 mL/s (n = 57) and 25.4 ± 14.7 mL/s (n = 51). SR was 67.3% (95% CI 57.6–77.0) at 12 and 58.2% (95% CI 47.7–68.7) at 24 months (conservative Kaplan Meier assessment). SR ranged between 85.7% and 0% in case of high and low surgical experience. Simple proportions of 12-month and 24-month SR for evaluable patients in all centers were 70.8% (46 of 65) and 76.9% (30 of 39). Except for one patient, no oral adverse event was reported. TEOMG is safe and efficient in urethroplasty. Functionality and safety of an authorized autologous tissue-engineered oral mucosa graft for urethroplasty was assessed 99 patients were included in a prospective, multicenter, non-interventional, independently monitored observational study Autologous tissue-engineered oral mucosa is a safe option for urethral reconstruction, with minimal donor-site morbidity 0.5% of male population are suffering from narrowed urethra, which untreated may lead to severe health problems. The diseased part of the urethra may be surgically substituted by healthy tissue. Native oral mucosa is used with good therapeutic success; however, its harvest is associated with oral complications. Regenerative medicine has brought forth a graft, cultured from a tiny oral mucosa piece from the patient. In a multicenter study with a mixed population of 99 patients, functionality and therapeutic success of the cultured graft was comparable to native oral mucosa under routine practice, with minimal donor site morbidity.
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