the Effect of Adipose Derived Stem Cells Combined With Platelet Rich Plasma Versus Platelet Rich Plasma Alone on Follicular Unit Extraction Hair Transplantion in Male Androgenic Alopecia: Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- hair growth
研究概览
简要总结
Androgenetic alopecia is the most common type of alopecia in both men and women. About 80 % of Caucasian men and 40-50 % of Caucasian women are affected by androgenetic alopecia. The psychological impact of hair loss due to Androgenetic alopecia can be profound.
详细描述
Currently, two medications are Food and Drug Administration approved in the treatment of Androgenetic alopecia which are minoxidil, and finasteride. Both medications must be taken indefinitely for benefits to persist. Hair transplantation is the only current successful permanent option. Nowadays, the majority of surgeons use 2 techniques, the classic strip technique, and the follicular unit extraction technique. Advantages of follicular unit extraction over the strip technique are the lesser incidence of donor zone post-procedural discomfort and the barely visible scarring.
Platelet rich plasma is an autologous concentration of platelets in small volume of plasma and is an exciting therapeutic option for hair growth. Combining platelet rich plasma with follicular unit extraction surgery for the treatment of Androgenetic alopecia demonstrated that PRP is able to minimize the postsurgical follicle loss and potentiate the performance of grafted hairs.
Adipose derived stem cells are an effective mesenchymal stem cell population with enormous potential in different fields of regenerative medicine.
Adipose stem cells are needed to induce the proliferation of bulge stem cells of hair follicle. Furthermore, they can help in wound healing and vascular neogenesis.
Zanzottera et al. 2014 investigated the effect of adipose derived stem cells on wound healing and engraftment of the transplanted hair applied during hair restoration surgery for three patients with androgenetic alopecia. Despite their promising results, further clinical trials including larger number of patients are still needed to confirm their preliminary findings.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •male patients with androgenetic alopecia between 18 years and 60 years
排除标准
- •Patients with Non-androgenetic causes of hair loss.
- •Female patients with androgenetic alopecia.
- •Patients who received anti-hair loss treatment within the past six months.
- •Patients with history of bleeding disorders or on anticoagulant therapy.
- •Patients with history of chronic liver disease, cancer or connective tissue disorders.
- •Patients with current scalp infection.
结局指标
主要结局
hair growth
时间窗: 12 months
Evaluate the effect of adipose derived stem cells intradermally injected in the recipient site during follicular unit extraction for the treatment of androgenetic alopecia on transplanted hair growth in terms of hair density (number of hairs / cm2) in the transplanted region using folliscope.
次要结局
- hair shaft diameter(12 months)
研究者
A Ghazally
principal investigator
Assiut University