A Single-Center, Randomized, Double-Blind, Placebo-Controlled Exploratory Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells Combined With Bovine Type I Collagen for Promoting Third-Degree Burn Wound Repair
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Re-epithelialization areas
研究概览
简要总结
To evaluate the safety and tolerability of human umbilical cord mesenchymal stem cells combined with bovine type I collagen in the treatment of third-degree burn wounds.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-65 years, gender unrestricted
- •Confirmed third-degree burns, wound area 1%-5% TBSA
- •Admission within 72 hours after burn injury
- •Voluntarily signed informed consent
- •Able to cooperate and complete follow-up
排除标准
- •Pregnant or lactating females
- •Severe immunodeficiency or autoimmune disease
- •History of malignant tumor, or coagulation dysfunction
- •Severe cardiac, hepatic, or renal insufficiency
- •Hypersensitivity to collagen or stem cell components
- •Uncontrollable severe wound infection
- •Participation in other clinical studies within the past 3 months
- •Inability to comply with follow-up
研究组 & 干预措施
Combination Therapy Group
Bovine type I collagen sponge + human umbilical cord mesenchymal stem cells (HUMSCs)
干预措施: HUMSCs combined with bovine type I collagen (Combination Product)
Collagen Control Group
Bovine type I collagen sponge alone
干预措施: bovine type I collagen (Biological)
Placebo Group
Sterile blank dressing / Vaseline gauze
干预措施: Sterile blank dressing / Vaseline gauze (Device)
结局指标
主要结局
Re-epithelialization areas
时间窗: Up to 6 month
Re-epithelialization will be determined by clinical evaluations and recorded by digital color photographs
Complete burn wound healing
时间窗: Up to 12 month
Time (days) to complete re-epithelialization of burned skin. It will be based on clinical evaluations and digital color photographs
次要结局
未报告次要终点