The Efficacy and Safety of Platelet Rich Plasma Combined With Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Patients With Stage 3 and 4 Stress Injury
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change From Baseline in Pressure Ulcer Scale for Healing (PUSH)
研究概览
简要总结
This study is an open-label, single-center trial which aim to evaluate of efficacy and safety of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) combined with platelet-rich plasma (PRP) in stage 3 and 4 stress injury.
详细描述
The 2019 edition of the International Guidelines for Clinical Prevention and Treatment of Stress Injury states that stress injury, as a globally prevalent health issue, significantly reduces the quality of life for patients and their families, increases economic burden, and leads to significant expenditure on medical resources. In recent years, the incidence and mortality rate of pressure injuries in hospitalized patients have been increasing year by year. Therefore, there is an urgent need to find a more effective treatment method for pressure injuries in clinical practice. Human umbilical cord mesenchymal stem cells (huMSCs) have immunomodulatory and anti-inflammatory effects. Platelet rich plasma (PRP) can also secrete various nutritional factors, which can effectively promote wound healing. Therefore, the combination of the two may be a more effective treatment method for pressure injuries. At present, there are few reports on the combination of PRP and huMSCs for the treatment of pressure injury. In this study, the investigators aim to evaluate the effectiveness and safety of PRP combined with huMSCs for stage 3 and 4 pressure injuries, In order to promote their clinical application.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old, regardless of gender;
- •Patients with stage 3 and stage 4 pressure injuries (According to National Pressure Ulcer Advisory Panel (NPUAP)/European Pressure Ulcer Advisory Panel (EPUAP) classification system for pressure ulcers);
- •There were no complications affecting the wound healing;
- •After through debridement for the first time, the wound volume meets the requirement of "10-100cm3"; Platelet count before treatment 100~300×109/L;
- •The patient voluntarily participates and signs an informed consent form.
排除标准
- •Individuals with coagulation dysfunction or hemorrhagic diseases;
- •People with skin diseases, diabetes and immune diseases;
- •Individuals with mental or psychological disorders;
- •Individuals with allergies to multiple drugs;
- •Pregnant or lactating women;
- •Those who need to take medication that affects platelet and coagulation function for a long time or in the near future, but have not stopped taking medication within the past week.
研究组 & 干预措施
Platelet-rich plasma (PRP) combined with human umbilical cord mesenchymal stem cells (huMSCs)
Inject 3ml PRP+huMSCs (5 × 106) into the edge and bottom of the wound, with 0.5 ml at each point and a distance of approximately 1-3 cm between each point. Then, apply autologous PRP gel (PRP+thrombin mixture, 2ml) evenly on the wound, with a thickness of about 2mm.
干预措施: Platelet-rich plasma (PRP) combined with human umbilical cord mesenchymal stem cells (huMSCs) (Biological)
Control group
Standard therapy
干预措施: Control group (Other)
结局指标
主要结局
Change From Baseline in Pressure Ulcer Scale for Healing (PUSH)
时间窗: Baseline,1,2,4 and 6 weeks
The scale includes three dimensions: wound area, exudate volume, and tissue type. The total score of the three dimensions was indicated the healing of pressure injury and ranged from 0 to 17 points, with 0 points indicating wound healing. The PUSH score decreased, indicating improvement. The total score increased, indicating deterioration. Multiple pressure injuries in the same patient were evaluated separately.
Change from baseline in Determination of growth factor content
时间窗: Baseline,1, 2 and 3 weeks
Serum epidermal growth factor (EGF) and vascular endothelial growth factor (VEGF) were detected during treatment.
次要结局
- Positive rate of bacterial culture(Baseline and 2 weeks)
- Wound healing time(up to 4 months)