New Autologous Fat Graft for the Treatment of Urethral Stricture
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- uroflow time 1
研究概览
简要总结
In 2001 Zuk showed that lipoaspirate contains multipotent adipose stem cells (ADSCs) like in the bone marrow, thereby expanding opportunities in multiple fields. ADSCs have emerged as a key element of regenerative medicine surgery due to their ability to differentiate into a variety of different cell lineages. Moreover, their capacity of paracrine secretion of a broad selection of cytokines, chemokines, and growth factors makes them highly clinically attractive. More specific, of particular interest are the anti-apoptotic, anti-inflammatory, proangiogenic, immunomodulatory, and anti-scarring effects that have been demonstrated for ADSCs, which effects on wound healing, soft-tissue restoration, and scar remodeling.
Nanofat firstly introduced by Tonnard in 2013, is an ultra-purified adipose tissue-derived product that is devoid of mature adipocytes but rich in ADSCs and with regenerative properties.
Nanofat represents a particular formulation of adipose grafting because it is liquid and it is easily transferable to tissues by injection. The nanofat because is free of whole adipocytes does not have the side effects of others adipose-derived formulations containing whole adipocytes (microfat, lipofilling, macrofat), such as the formation of deposits, granulomas, oily cysts, keloids.
Investigators aim to evaluate the use of nanofat grafting in the treatment in urethral strictures of the female and male urethras.
详细描述
Urethral stricture is the reduction of the urethral lumen due to the growth of scar tissue inside the urethral wall, due to various causes.
In the last thirty years, in reconstructive urethral surgery have been described several urethroplasties to repair the urethra and to restore urinary flow.
Obstructed stricture were treated with the removal of the urethral tract stricture and with the anastomosis of the two urethral stumps by the technique called "end-to end anastomosis". This technique is today reserved only for cases of complete urethral stricture of the male urethra because it causes many negative consequences on the sexual activity: shortening of the urethra and the penis, abnormal curvature of the penis in erection, reduction of penile sensitivity. In female urethral stricture this technique has never been used.
Many urethroplasties have been described with the enlargement of the urethra with a good success rate, but some risks such as the formation of fistulas and redo of the stricture. Today several autologous graft tissues are used including the genital and extragenital skin and the buccal mucosa. The use of preputial skin requires complete circumcision and is often not accepted by the patient. The use of extragenital skin is invasive and is used in some long male urethral stricture, while it is not used in female urethral reconstruction.
The buccal mucosa is today considered the optimal graft tissue, due to its histological characteristics that make it suitable for the reparative urethral surgery. However, it must be considered that the withdrawal can be a potential cause of oral complications and, moreover, there is a limit to the length of the tissue that can be taken and is a medium invasive procedure, with discomfort of the patient in the days following the harvest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Urethral stricture naive or recurrent in male and female patients aged > 18 y.o.
排除标准
- •Neurogenic urinary tract disorders
- •Urinary tract infections
- •Age < 18 y.o.
结局指标
主要结局
uroflow time 1
时间窗: 90 days after nonfat grafting
Uroflowmetry examination (ml/sec)
Functional time 1
时间窗: 90 days after nonfat grafting
Post ovoidal residue (ML)
Functional time 2
时间窗: 180 days after nonfat grafting
Post ovoidal residue (ML)
uroflow time 2
时间窗: 180 days after nonfat grafting
Uroflowmetry examination (ml/sec)
次要结局
未报告次要终点
研究者
Antonio Luigi Pastore
Associate Professor
University of Roma La Sapienza
