Phase I-II, Multicenter, Randomized, Controlled, Proof of Concept Clinical Trial to Determine Feasibility, Safety and Efficacy of the Use of Allogenic Adipose-derived Adult Mesenchymal Stem Cells Expanded on Fibrinhyaluronic Biological Matrix in the Treatment of Venous Ulcer of the Lower Limbs
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Factibility of Bioengineered Artificial Mesenchimal Sheet measured as the remission of the treated fistula.
研究概览
简要总结
Phase I-II, Multicenter, Randomized, Controlled, Proof of Concept Clinical Trial to determine feasibility, safety and efficacy of the use of Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrinhyaluronic biological matrix in the treatment of venous ulcer of the lower limbs.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signing of the informed consent (IC) after reading the patient information sheet.
- •Over 18 years of both sexes.
- •Active or recurrent venous ulcer in the lower extremity with an area between 5-10 cm2
- •Grade III injury on the Widmer scale.
- •Independence and/or availability to go to the referral center on an outpatient basis.
- •Distal pulses in palpable lower limbs (tibial and foot). ABI between 0.8 - 1.3
排除标准
- •Any pathology for which the investigator considers that compression bandaging is contraindicated and/or previous acute deep vein thrombosis (DVT), within the first 10 days from the onset of symptoms.
- •Grade III obesity with a body mass index (BMI) >40; or underweight patients (BMI <18.5).
- •Active neoplasia and/or being treated with cytostatics.
- •Patients undergoing radiotherapy treatment in areas close to the lesion.
- •Clinical signs of colonization or local infection of the lesion.
- •Patients with more than one lesion compatible with UV in the same lower limb.
- •Erysipelas.
- •Infectious cellulite.
- •Osteomyelitis.
- •Lymphangitis.
- •Chronic lymphedema.
- •Therapy with corticosteroids or immunosuppressants.
- •Venous ulcer grade I or II on the Widmer scale.
- •Lesions close to possible or diagnosed cancerous lesions.
- •Non-localized wounds in the lower extremities.
- •Ongoing infection and/or sepsis.
- •Critical ischemia in the lower limbs or other venous diseases of unknown origin.
- •Immunocompromised patients.
- •Dependent patients with severe mobility limitations.
- •Dialysis patients.
结局指标
主要结局
Factibility of Bioengineered Artificial Mesenchimal Sheet measured as the remission of the treated fistula.
时间窗: Through study completion, an average of 1 year
To evaluate the factibility of the topical application of CMTAd in a biological matrix of fibrin-hyaluronic acid on venous ulcers (VU).
Safety of Bioengineered Artificial Mesenchimal Sheet measured by the incidence of adverse events
时间窗: Through study completion, an average of 1 year
To examine the safety of cutaneous administration of CMTAd in a biological matrix of fibrin-hyaluronic acid on VUs compared to standard treatment.
次要结局
未报告次要终点