NCT07580755招募中不适用
A Randomized Controlled Study on the Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Extensive Burns
The First Affiliated Hospital of Xinxiang Medical College1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年4月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
研究概览
简要总结
Burn patients were randomly divided into the low-dose stem cell gel group, the high-dose stem cell gel group, and the placebo group (with only the gel), and received the same treatment under the same conditions simultaneously.
详细描述
This study adopted a randomized, double-blind, parallel-controlled research method. It planned to enroll 90 burn patients who underwent autologous thick skin transplantation. These patients were randomly divided into the low-dose stem cell gel group, the high-dose stem cell gel group, and the placebo group (with only the gel), with 30 patients in each group. The three groups of subjects received the same treatment under the same conditions simultaneously.
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
- Double (Participant, 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
- •Voluntary participation and signing of the informed consent form;
- •Burn patients, subjects requiring autologous skin grafting;
- •Age 18 to 65 years old, gender not restricted;
- •During this clinical study, single person, single donor skin area (lateral thigh or trunk) treatment;
- •Skin burn area < 30% of total body surface area (TBSA);
- •The donor skin area is the first time for donation, and the donor skin area is medium-thick skin (thickness approximately 0.4mm);
- •The area of the excised skin flap ≥ 90 cm2;
- •Able to cooperate with this study protocol and accept regular postoperative follow-up visits.
排除标准
- •Those allergic to sodium alginate (gel component);
- •Electric shock injuries, chemical burns, radiation injuries or combined with other traumas;
- •Subjects with severe systemic diseases (judged by the researchers);
- •Subjects with uncontrolled hypertension or diabetes (judged by the researchers);
- •Pregnant or lactating women;
- •Subjects whose condition may affect the study assessment or require the concurrent use of medical treatments that may affect the efficacy assessment;
- •Subjects with acute or chronic kidney diseases, renal failure or serum creatinine level = 1.5 times the upper limit of normal value;
- •Subjects with acute or chronic liver diseases, total bilirubin, alanine aminotransferase, aspartate aminotransferase = 2.0 times the upper limit of normal value;
- •Subjects with a history of malignant tumors;
- •Subjects who have participated in other clinical studies for less than 3 months;
- •Subjects with mental disorders and without self-awareness, unable to express clearly;
- •Subjects using immunosuppressants and those who have been using corticosteroids for a long time (more than 1 month) (excluding local application);
- •Subjects with infectious diseases (any one of the four items positive in the test);
- •Subjects with other severe systemic diseases;
- •Other subjects that the researchers consider not eligible for inclusion.
研究者
研究点 (1)
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