Clinical Study on Umbilical Cord Mesenchymal Stem Cells for Wound Repair in Large Area Burn Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Wound healing rate
研究概览
简要总结
This study intends to adopt a prospective, open, and randomized controlled research method to explore the effectiveness and safety of using human umbilical cord mesenchymal stem cells to treat large-scale burn wounds, in order to break through the limitations of various current treatment methods, explore new clinical treatment methods, promote the repair and healing of skin lesions, and further improve the cure rate and quality of life of patients.
详细描述
Large area deep burn patients, due to extensive skin defects in their limbs that cannot be repaired by the body itself, need to undergo skin grafting surgery to seal the wound. Although skin transplantation can partially meet the needs of wound sealing, the skin scar hyperplasia after transplantation and healing is significant, affecting the appearance and motor function of the limbs. Moreover, the healed skin lacks dermal tissue and sweat glands and other skin accessories, resulting in poor skin quality after wound healing, And accompanied by obvious discomfort such as fear of heat, itching, and pain, which seriously affects the patient's quality of life. Mesenchymal stem cells have high differentiation potential and can differentiate across embryonic boundaries into epithelial tissue cells such as skin. They can also secrete various cytokines to produce chemotactic and anti apoptotic effects, promoting the formation of wound neovascularization and wound healing. Human umbilical cord mesenchymal stem cells, due to their convenient and painless source, have become good seed cells for promoting wound healing.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Selected patients are voluntary and sign an "informed consent form";
- •Burn wound area ≥ 20% TBSA, and III ° wound area ≥ 2% TBSA;
- •Age range from 18 to 65 years old, regardless of gender;
- •Plan to perform two or more limb III degree wounds with scab cutting and autologous skin grafting surgery for treatment;
- •No severe heart, lung, blood system, or nervous system diseases;
- •There are no clear complications such as systemic infections.
排除标准
- •Patients who do not agree to participate in this experimental study;
- •Age<18 years old or>65 years old;
- •Patients with definite malignant tumors, AIDS, diabetes, and autoimmune diseases;
- •Pregnant or lactating patients;
- •Individuals with systemic dysfunction;
- •Patients with acute and chronic liver and kidney diseases;
- •Poor compliance makes it difficult to complete the experiment.
结局指标
主要结局
Wound healing rate
时间窗: On the 21st and 28th days after surgery
(Total area of wound in the operating area - area of unhealed wound)/Total area of wound in the operating area × 100%
次要结局
未报告次要终点
研究者
ShiCang Yu
Director
Southwest Hospital, China