Successful Treatment of Female Pattern Hair Loss With Non-Cultured Adipose Derived Stem Cells (ADSCs) in Mechanically Emulsified Adipose Tissue (Nanofat) With and Without Platelet-Rich Plasma (PRP): A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Increase in terminal hair count
研究概览
简要总结
Background: FPHL is a chronic progressive condition that necessitates lifelong management. Over time, patients who respond to conventional therapy may experience a decrease in the effectiveness of their treatment and may require alternative interventions to delay disease progression and enhance the efficacy of current therapies. ADSCs have demonstrated potential as a regenerative interventional modality for the treatment of such conditions.
Objective: To compare efficacy of nanofat alone and nanofat combined with platelet-rich plasma (PRP) for the treatment of female-pattern hair loss.
Methods: This study is a randomized controlled prospective intervention. Forty patients with mild to moderate FPHL were selected and randomly allocated into two groups (A and B). Both groups received a single session of nanofat scalp injection. Nanofat was prepared from lipoaspirates by mechanical agitation of adipose tissue, and was mixed with PRP for patients allocated in group B.
Results: Nanofat alone and combined with PRP promoted hair regrowth. However, the adjunctive use of PRP with nanofat yielded a statistically significant enhancement in terminal hair thickness (P <0.001) and count (P <0.001) compared with nanofat alone. Mean satisfaction score was 3 out of 5 at 24 weeks post-injection, with no significant difference between the two treatment groups (P= 0.937). The side effects were mild and well-tolerated.
Conclusion: Both nanofat, alone and in combination with PRP, improved hair thickness and count in patients with FPHL. The combination with PRP demonstrated a statistically significant improvement compared with nanofat alone.
详细描述
Patients and Methods This randomized controlled clinical trial was conducted on 40 female patients presenting with pattern hair loss, selected from the outpatient clinic of Dermatology, Venereology, and Andrology Department, Ain Shams University Hospitals, between December 2022 and July 2023.
Following approval from the research ethics committee of the Faculty of Medicine, Ain Shams University (FMASU MS 167/2023), written informed consent was obtained from each patient after providing information regarding procedural steps and potential side effects or complications.
The study population comprised females aged 18-50 years with moderate to severe FPHL, classified as Sinclair grades 3-4. Exclusion criteria included age < 18 years and >50 years, chronic telogen effluvium, use of topical or systemic FPHL treatments in the preceding 6 months, infection at the treatment site or elsewhere, diabetes, hemorrhagic disorders, anticoagulant therapy, pregnancy or lactation, personal or family history of malignancy, immunosuppression or lidocaine allergy.
The clinical diagnosis of FPHL was confirmed according to Rakowska et al., 2009 trichoscopic criteria for diagnosis of FPHL. FPHL is diagnosed by the presence of two major criteria or one major and two minor criteria.
Digital photography was documented at a point 10 cm directly above the midpoint of the glabella at the initial visit and at all subsequent visits. Patients were evaluated clinically and trichoscopically at baseline, then at 12 and 24 weeks after treatment.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged 18-50 years with moderate to severe FPHL, classified as Sinclair grades 2-4.
排除标准
- •Age less than 18 years or more than 50 years
- •Chronic telogen effluvium
- •Use of topical or systemic FPHL treatments in the preceding 6 months
- •Infection at the treatment site or elsewhere
- •Uncontrolled iabetes, hemorrhagic disorders, anticoagulant therapy, pregnancy or lactation
- •Personal or family history of malignancy, immunosuppression or lidocaine allergy.
研究组 & 干预措施
Nanofat mixed with PRP
20 patients received a single session of scalp injection with nanofat mixed with PRP.
干预措施: Nanofat mixed with PRP (Procedure)
Nanofat only
20 patients received a single session of scalp injection with nanofat only.
干预措施: Nanofat only (Procedure)
结局指标
主要结局
Increase in terminal hair count
时间窗: 24 weeks
After treatment with ADSCs, the anticipated primary outcome measure is trichoscopic increase in terminal hair count. This was compared with nanofat alone versus mixed with PRP.
Increase in terminal hair thickness
时间窗: 24 weeks
After treatment with ADSCs, the anticipated primary outcome measure is trichoscopic increase in terminal hair thickness. This was compared with nanofat alone versus mixed with PRP.
次要结局
未报告次要终点