A Phase Ι/Π Study of Human Cord Blood Mononuclear Cells and Human Umbilical Cord Mesenchymal Stem Cells Transplantation in Patients With Acute Burn
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The ratio of wound contraction and re-epithelialisation
研究概览
简要总结
Burn trauma,especially extensive ones, remains a life-threatening local and general inflammatory condition destroying the skin and underlying tissues, and resulting in serious sequelae. Remarkable progress has been achieved during last 30 years，stem cell therapy plays an important role in this progress. Human umbilical cord mesenchymal stem cells (hUCMSCs) and human cord blood mononuclear cells (hCBMNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy for burn. In this study, the safety and efficacy of hUCMSCs and hCBMNCs transplantation will be evaluated in patients with acute burn.
详细描述
To investigate the safety and efficacy of human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells transplantation in patients of Acute, Moderate-Severe, Full-thickness burn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Between age 18- 65 years, both gender.
- •Diagnosed with Acute, Moderate-Severe, full-thickness burn:
- •Burn occurring within the 72 hours prior to administration. TBSA 20-55%, third degree wounds surface area < 19 % ;
- •Willing to sign the Informed Consent Form.
排除标准
- •All other burns except thermal origin.
- •Chronically malnourished, poor medical condition or shock
- •Systemic inflammatory response syndrome (SIRS) or septicopyemia
- •Moderate-severe inhalation injury airways to lung
- •Autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.
- •Severe pulmonary and hematological disease, malignancy or hypo-immunity.
- •Currently undertaking other treatment that may affect the safety/efficacy of stem cells.
- •Pregnancy or lactation
- •Enrollment in other trials in the last 3 months.
- •Other criteria the investigator consider improper for inclusion.
研究组 & 干预措施
Group1 :Conventional plus hUCMSCs treatment
Participants will be given conventional therapy plus human cord mesenchymal stem cells transplantation with a 6 months follow-up.
干预措施: human umbilical cord mesenchymal stem cells (Biological)
Group 2: Conventional plus hCBMNCs and hUCMSCs therapy
Participants will be given conventional therapy plus combination of hCBMNCs together with hUCMSCs transplantation with a 6 months follow-up.
干预措施: human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells (Biological)
Group 3:Conventional therapy
Participants will be given conventional therapy only with a 6 months follow-up.
干预措施: Conventional therapy (Drug)
结局指标
主要结局
The ratio of wound contraction and re-epithelialisation
时间窗: 6 months after treatment
Complete healing time for investigated burn area
时间窗: 6 months after treatment
Vancouver Scar Scale
时间窗: 6 months after treatment
次要结局
- Incidence of infections and bleedings in burn wounds(6 months after treatment])
- Engraftment assessment: Vitality of the graft(6 months after treatment])
- McGill pain Questionnaire(6 months after treatment)
- Incidence of Adverse Events and Serious Adverse Events(6 months after treatment)