Effects of Human Amniotic-derived Mesenchymal Stem Cells (hAMSCs) on Calciphylaxis Patients: An Open-Label Single-Arm Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Wound Healing
研究概览
简要总结
Treatment for Calciphylaxis Patients with Human Amniotic-derived Mesenchymal Stem Cells
详细描述
Calciphylaxis is a rare, devastating disorder causing excruciatingly painful ischemic skin lesions. Sepsis due to the infection of ulcerated wounds is a common cause of death. To date, practical therapies typically include wound care, pain management, anti-infection, anticoagulant and aggressive treatment of predisposing conditions. Drugs such as sodium thiosulfate(STS), bisphosphonate, SNF472 and cinacalcet are also suggested. However, it's still a lethal disease with 1-year mortality up to 80% for dialysis patients. Here the investigators plan to treat calciphylaxis patients with human amniotic-derived mesenchymal stem cells (hAMSCs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old.
- •Clinical diagnosis of calciphylaxis, including patients with chronic kidney disease who did not or had regular dialysis (hemodialysis or peritoneal dialysis).
- •All subjects signed informed consent.
排除标准
- •Patients who refuse to sign informed consent.
- •Patients with malignant tumors or severe psychiatric disorders, or an expected survival time of less than 6 months.
- •Pregnant or lactating women of childbearing age.
- •Participation in another clinical trial with an experimental drug within 90 days prior the inclusion.
研究组 & 干预措施
hAMSC Treatment Group
hAMSC treatment regimen: (1) Intravenous infusion: 1.0×10⁶ cells/kg administered three times consecutively at weeks 1, 2, and 4, followed by once every 4 weeks for a total of 8 doses (6 months). (2) Local injection: 2.0×10⁴ cells/cm² of wound area, administered concurrently. Treatment may be terminated earlier or extended based on clinical condition.
干预措施: Human amniotic-derived mesenchymal stem cells (Biological)
结局指标
主要结局
Wound Healing
时间窗: Up to 1 year.
The Bates-Jensen Wound Assessment (BWAT) is a standardized tool for quantitative assessment of wound healing that includes the 13 items listed below: (1)Size; (2)Depth; (3)Edges; (4)Undermining or pockets; (5)Necrotic tissue type; (6)Necrotic tissue amount; (7)Exudate type; (8)Exudate amount; (9)Surrounding skin color; (10)Peripheral tissue edema; (11)Peripheral tissue induration; (12)Granulation tissue; (13)Epithelialization. Each item was rated on a scale of 1 (best) to 5 (worst). The BWAT total score is the sum of the individual items with a possible range of 13 (best) to 65 (worst).
次要结局
- Wound Pain(Up to 1 year.)
- Systemic Infection(Up to 1 year.)
- Survival State(From date of treatment until the date of die, assessed up to 1 year.)
- Measured Quality of Life(Up to 1 year.)
研究者
Ningning Wang
Professor
The First Affiliated Hospital with Nanjing Medical University