Allogenic Mesenchymal Stromal Cells for the Treatment of Burn Wounds.
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Re-epithelialization areas
研究概览
简要总结
The goal of this study is to evaluate the capacity of allogenic mesenchymal stromal cells form bone marrow (BM-MSC) or adipose tissue(Ad-MSC) to induce wound healing in patients with burn wounds.
详细描述
Based on the paracrine and immunomodulatory effects of MSCs, they are considered promising cells for tissue engineering and skin regeneration in burn wounds. This protocol is designed to evaluate the efficacy of transplantation of allogenic BM-MSCs or Ad-MSCs, included in preclotted platelet-rich plasma (PRP), in patients with deep- or full-thickness burns (second- or third-degree / AB B or B degree). All patients will receive concomitant first-line treatments.
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
- 2 Weeks 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 2 weeks and 85 years old
- •Patient with second- or third-degree burn (AB/B or B).
- •Thermal burns
- •Electrical burns
- •Chemical burns
- •Informed consent of the patient or caretaker
排除标准
- •First degree burn (A or AB)
- •Evidence of active infection at the wound site
- •Chronic malnutrition
- •Systemic inflammatory response syndrome (SIRS) or sepsis
- •Moderate or severe respiratory tract or lungs burn injuries
- •Autoimmune disease (e.g. multiple sclerosis, lupus erythematosus)
- •Severe pulmonary disease, hematologic disease, malignancy, or hypo-immunity.
- •Pregnancy
结局指标
主要结局
Re-epithelialization areas
时间窗: Up to 6 month
Re-epithelialization will be determined by clinical evaluations and recorded by digital color photographs
Complete burn wound healing
时间窗: Up to 12 month
Time (days) to complete re-epithelialization of burned skin. It will be based on clinical evaluations and digital color photographs
次要结局
未报告次要终点
研究者
Dylana Diaz Solano
Investigator
Instituto Venezolano de Investigaciones Cientificas