Autologous Bone Marrow Derived Cells in the Treatment of Venous Leg Ulcers Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Reduction of the ulcer area at 6 months
研究概览
简要总结
Chronic venous leg ulcers (CVU) represent a medical problem associated with significant morbidity, increased work absenteeism and earlier retirement as a consequence of disability. This strongly affects the patient's quality of life and has a significant economic impact on healthcare systems.
Reports of studies with animal models show that treatment with bone marrow-derived stem cells has a beneficial effect in healing chronic skin wounds.
The purpose of this pilot study is to determine the safety and feasibility of cell therapy with bone marrow derived cells (BMDC) as a complementary healing therapy in chronic venous leg ulcers, and in addition to evaluate its effectiveness. The knowledge gained in the pilot study will be used to refine the clinical protocol procedures of a subsequent randomized study.
Patients with venous legs ulcers meeting eligibility criteria and providing appropriate written informed consent will be enrolled for study participation. Enrolled patients will receive Autologous BMDC implantation at de venous ulcer in conjunction with standard of care (SOC) treatment.
During follow up, adverse events will be assessed by ulcer clinical examination. Effectiveness of the experimental treatment will be assessed by evaluating ulcer healing (reduction of the ulcer area) and pain reduction over a six-month period.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 40 to 75 years
- •Patients with primary venous insufficiency
- •Patients with venous ulcers with area larger than 2 cm2, who have received SOC treatment in the previous three months.
- •Ulcers with negative bacterial cultures or with polymicrobial flora.
排除标准
- •Patients with decompensated heart failure.
- •Patients with lower limb edema of nonvenous etiology.
- •Patients with diagnosis of diabetes mellitus.
- •Patients with body mass index (BMI) ≤ 18.5 or > 40.
结局指标
主要结局
Reduction of the ulcer area at 6 months
时间窗: 6 months
Measurement of the ulcer area (cm2) and comparison with baseline.
Reduction of the ulcer area at 2 months
时间窗: 2 months
Measurement of the ulcer area (cm2) and comparison with baseline.
Reduction of the ulcer area at 4 months
时间窗: 4 months
Measurement of the ulcer area (cm2) and comparison with baseline.
次要结局
- Absence of adverse events related with the intervention(From date of cells implantation until the date of the event, assesed up to 7 days)
- Pain reduction at 2 months(2 months after intervention)
- Pain reduction at 4 months(4 months after intervention)
- Pain reduction at 6 months(6 months after intervention)
研究者
Cristina Touriño, MD, PhD
Coordinator of the
Hospital de Clínicas Dr. Manuel Quintela