Autologous Transplantation of Cultured Fibroblast on Amniotic Membrane for Mitten Hand Deformity in Patients With Epidermolysis Bullosa
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Infection
研究概览
简要总结
Epidermolysis Bullosa (EB) is a blistering disease that is caused by defective anchoring fibrils and hemidesmosome in basement membrane of the skin layer. EB is inherited either autosomal or recessive and has 3 types. Recessive Dystrophic Epidermolysis Bullosa (RDEB) is severe with some morbidity such as mitten hand deformity.
The management of these patients is very difficult because no effective treatment has been known yet.
The EB patients with mitten hand deformity need surgery to have a biologic dressing for areas of hand which is without the skin. In this study the investigators assess the safety of autologous transplantation of cultured fibroblast on amniotic membrane (AM,as coverage) for them.
详细描述
Epidermolysis Bullosa patients with mitten hand deformity were included. (based on inclusion & exclusion criteria) These patients should be offered for surgery to release the adhesions between fingers and MCP. When the consent form was accepted and the lab test was confirmed, a small skin biopsy was removed from retro auricle and fibroblast cells were separated and cultured. These cells were seeded on AM and the microbial test was done as evidence to prove the safety.
Under general anesthesia, when the hands adhesion was removed, the autologous fibroblast cultured on AM was transplanted to the both hands (specially the area without skin coverage) and the hands were dressed afterward.
The dressing was changed and the wound was checked regularly to detect any complications.
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
- 5 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders Age: 5-25y No history of other systemic disease No history of other cell therapy method No infection in donor or recipient site HCV Ab/HIV Ab/ HBS Ag tests were negative
排除标准
- •Age less than 5y or more than 25y. History of other systemic disease History of other cell therapy method Infection in donor or recipient site Positive Lab tests for contagious viral diseases Pregnancy or lactating History of malignancy
研究组 & 干预措施
fibroblast transplant
Transplantation of autologous cultured fibroblast on amniotic membrane in patients with Epidermolysis Bullosa with mitten hand deformity
干预措施: Cell transplantation (Biological)
结局指标
主要结局
Infection
时间窗: 1week
Evaluation the symptoms of any infection in the site of transplantation during 1week after transplantation.
Bleeding
时间窗: 1week
Evaluation the presence of any bleeding at the site of transplantation during 1 week after transplantation.
Healing
时间窗: 1month
Evaluation the healing of ulcers 1month after transplantation base on changing the dressing time.
Pain
时间窗: 1month
Evaluation the pain reduction 1 month after cell transplantation by VAS scoring.
次要结局
- new ulceration(3months)
- Range of motion(6months)