Implantation of Mesenchymal Stem Cell, Conditioned Medium, or Triamcinolone Acetonide for Keloid Regression: Immunohistochemistry, Histopathology and Imaging Study
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 主要终点
- Alfa SMA-1
研究概览
简要总结
The clinical trial will be carried out at the Gatot Soebroto Army Central Hospital, Jakarta and planned from June 2020 to December 2020. Clinical trials of Umbilical Cord-Mesenchymal Stem Cells (UC-MSCs) and Conditioned Medium Umbilical Cord-Mesenchymal Stem Cells (CM UC-MSCs) for Keloid were designed in three groups. Group 1 injected with The UC-MSCs at a dose of 2 million cells / cm3 using a 1 cc injection syringe (27G) by intra-lesion injection and booster with CM UC-MSCs at a dose of 1 cc / cm3 using a 1 cc injection syringe (27G) by intra-lesion injection and booster with CM UC-MSCs at the same dose 3 weeks later. Group 3 injected with Triamcinolon acetonide (TA) at a dose of 40 mg / cc / cm3 using 1 cc (27 G) syringe and booster with TA at 3 weeks later. The study subjects each group amounted to 7 patients suffering from Keloid. Patients were evaluated for 3 months after injection.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Surgery history of more than 3 months
- •Has keloid that the maximum size is 15 cm and thickness is 3-5 mm
排除标准
- •Patients with kidney failure
- •Pregnancy
- •Breastfeeding
- •Liver dysfunction
- •Blood disorders
- •Currently receiving immunosuppressant therapy (chemotherapy or steroids)
- •Refusing to participate in the study
研究组 & 干预措施
UC-MSCs + CM
A patient will be given UC-MSCs 2 million cells / cm3. After 3 weeks, the patient will be given CM 1 cc / cm3. The maximum size of Keloid is 15 cm per patient.
干预措施: Umbilical Cord-Mesenchymal Stem Cells and Conditioned Medium (Biological)
UC-MSCs + CM
A patient will be given UC-MSCs 2 million cells / cm3. After 3 weeks, the patient will be given CM 1 cc / cm3. The maximum size of Keloid is 15 cm per patient.
干预措施: Conditioned Medium (Biological)
CM + CM
A patient will be given CM 1 cc / cm3. After 3 weeks, the patient will be given CM 1 cc / cm3. The maximum size of Keloid is 15 cm per patient.
干预措施: Conditioned Medium (Biological)
Triamcinolon acetonide
A patient will be given Triamcinolone acetonide 40 mg / cc / cm3. After 3 weeks the patient will be given Triamcinolone acetonide 40 mg/cc / cm3. The maximum size of Keloid is 15 cm per patient.
干预措施: Triamcinolone Acetonide (Biological)
结局指标
主要结局
Alfa SMA-1
时间窗: 3 month after injection
Biomarker
Collagen type 1
时间窗: 3 moth after injection
Biomarker
次要结局
- Core Biopsy/Histopathology(3 month after injection)
- Ultrasonography(3 month after injection)