NCT02672280Unknown1 期
Safety and Exploratory Efficacy Study of Collagen Membrane With Mesenchymal Stem Cells in the Treatment of Skin Defects
South China Research Center for Stem Cell and Regenerative Medicine0 个研究点目标入组 30 人开始时间: 2016年5月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 主要终点
- Incidence of adverse events that are related to study treatment and associated with the grafting site
研究概览
简要总结
The purpose of the present study is to evaluate the safety and exploratory efficacy of the medical collagen membrane with umbilical cord derived mesenchymal stem cells in the treatment of patients with skin defects.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70, borh gender.
- •Patient able and willing to sign informed consent and comply with study procedures.
- •Women of childbearing potential must use birth control pills, barriers or abstinence and have a negative pregnancy test.
- •Deep partial or full thickness skin defect of at least 9 cm2 requiring surgical wound coverage due to: burn injury, diabetic foot ulcer or wounds caused by mechanical damage or iatrogenic injury.
排除标准
- •Patient refusal.
- •Patient has a documented history of allergy or sensitivity to any of the animal products used in preparation of skin substitute. These products include bovine blood, bovine collagen, and bovine collagenase.
- •Patient has a documented history of allergy or sensitivity to any of the antimicrobials or reagents used in preparation and application of skin substitute including the irrigation solution used before and after grafting.
- •Patient has a current diagnosis of an invasive burn wound infection in unexcised burn wound.
- •Patient has tunnels or sinus tracts that cannot be completely debrided.
- •Serious primary diseases of the liver, kidney and hematopoietic system, Abnormal liver function(glutamic-pyruvic transaminase(ALT), glutamicoxalacetic transaminase (AST) is 2 times higher than the normal value), creatinine(Cr) is higher than the upper limit of the normal value.
- •Other clinical trial participants within 3 months.
- •A random blood sugar reading >/=450 mg/dL.
- •Investigators judge other conditions not suitable for inclusion.
结局指标
主要结局
Incidence of adverse events that are related to study treatment and associated with the grafting site
时间窗: Up to Month 36 after the last grafting day
Percentage of wound closure as determined
时间窗: Up to Month 3 after the last grafting day
次要结局
- Incidence of all adverse events(Up to Month 36 after the last grafting day)
- Scar outcome assessment(Up to Month 36 after the last grafting day)
- Incidence of increased temperature sensitivity(Up to Month 36 after the last grafting day)
- Incidence and severity of infections at grafting sites(Up to Month 6 after the last grafting day)
- Incidence of contracture release or revision surgeries(Up to Month 36 after the last grafting day)
- Incidence of paresthesias, pain, dulling of sensation assessed(Up to Month 36 after the last grafting day)
- Percentage area of re-grafting as determined(Up to Month 6 after the last grafting day)
研究者
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