Treatment of Pressure Ulcers With Autologous Bone Marrow Stem Cells in Spinal Cord Injury Patients.Phase I/II Study.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Absence of adverse effects during timeframe as infections or complications related with the intervention.
研究概览
简要总结
The aim of the study is to determine the safety and feasibility of an autologous mononuclear stem cells infusion in pressure ulcers of paraplegic patients; and moreover, to evaluate the efficacy of the treatment.
详细描述
Taking into account the encouraging results obtained in the treatment of non-healing chronic wounds using bone marrow cells Given that treatment strategies for pressure ulcers can be both costly and complex, in this study we examine the possibility of improving pressure ulcer healing using stem cell therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Type IV ulcer pressures of more than 4 months topical treatment without response
- •No option for conventional surgery
- •Age range of 18-75 years old
排除标准
- •Patients out of inclusion age range
- •Patients with evidences of mental illness
- •Patients with evidences of previous alcohol or drugs dependencies
- •Pregnant women
- •Patients with present or previous malignant disease during the last 5 years, except for basal cell carcinoma
结局指标
主要结局
Absence of adverse effects during timeframe as infections or complications related with the intervention.
时间窗: Six months
The proposed trial will involve the recruitment of a total of 30 patients. The cells will be collected via bone marrow sampling. The aspirate will centrifuged on a Ficoll density gradient to isolate mononuclear cells, wich will be resuspended in heparinized isotonic saline for infusion into the area of the wound. Assessment of adverse events will be by wound examination and laboratory (microbiological)parameters
次要结局
- Improvement and closure of the pressure ulcer(One year)