Autologous Cellular Micro-graft in Surgical Treatment of Stable Resistant Vitiligo: A Randomized Self-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- comparing change in surface area in three arms
研究概览
简要总结
This is a double blinded self controlled randomized trial to assess Autologous Micro Cellular Grafts in surgical treatment of stable resistant vitiligo. Given the stem cells, progenitor cells, and growth factors rich hair follicle based suspension resulting from Autologous Cellular Micro grafts (ACM), we aim at assessing the efficacy of ACM generated suspension in comparison to follicle cell suspension in surgical treatment of stable resistant vitiligo.
详细描述
Prior to surgery, two comparable lesions will be selected.
Lesions will be assessed for:
- Surface Area using point counting technique.
- Any attempts of pigmentation using VESTA score. Lesions will be derma braded under local anesthesia using fractional laser CO2 resurfacing, Using dot mode off resurfacing will be performed at a power of 18-20 W, dwell time 1,000 milliseconds (DEKA, Florence, Italy). One to three passes will be performed until the epidermis is removed uniformly.
Autologous Cellular Micrografts (ACM) suspension generated by regenera technique Under local anesthesia, a 2.5 mm punch biopsy will be used to extract 3 scalp tissue specimens from the patient's occiput behind the ear, using Rigeneracons medical device (CE certified class I; Human Brain Wave, Turin, Italy). The collected specimens will be placed in Rigeneracons by adding 1.5 mL of sterile physiologic solution to the device. The device then generates a cellular suspension by rotation of Rigeneracons at 80 RPM for 2 minutes. Subsequently, the obtained suspension is diluted with an additional 3 mL sterile physiologic solution. The resulting suspension will be added to melanocyte pellet generated by NCES technique and will be spread on one of the derma braded vitiliginous patches.
Non cultured Epidermal Suspension (NCES):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The investigator doing the procedure is the only one who will know which side is assigned to which procedure, but the rest of the investigators including the ones assessing the outcome will be blinded
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
- •Patients with non-segmental vitiligo (NSV) / segmental resistant lesions; with either 2 comparable lesions or large patches that can be divided
- •Stability for ≥ 1 year
- •Age >18 years
- •Lack of treatment for at least 1 month prior to surgery.
排除标准
- •-Vitiligo lesions responsive to conventional treatment modalities
- •Active vitiligo; new lesions, expansion of old lesions or koebnerization in < 1 year
- •Age < 18 years.
- •Keloidal tendency
- •Bleeding tendency
- •Pregnant females.
结局指标
主要结局
comparing change in surface area in three arms
时间窗: 3 months follow up are required to assess response
Percent change in surface area calculated by point counting technique will be compared between three arms
次要结局
- comparing percent of repigmentation in three arms(3 months follow up are required to assess response)
研究者
Rania Mogawer
Principal investigator
Cairo University