2024-513151-33-00招募中2 期
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 fibrin-hyaluronic biological matrix in the treatment of venous ulcer of the lower limbs.
Fundacion Progreso Y Salud2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年4月22日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility and Safety
研究概览
简要总结
Feasibility and Safety
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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 (C6 according to the CEAC clinical classification, Annex 5)” in the lower extremity with an area between 5-10 cm
- •Grade III injury on the Widmer scale.
- •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. The following comorbidities will be allowed: peripheral vascular disease, coronary heart disease, chronic kidney disease, chronic liver disease, and arterial hypertension.
- •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.
- •Lymphangitis in the limb to be treated.
- •Chronic lymphedema in the limb to be treated.
- •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 systemic infection.
- •Critical ischemia in the lower limbs or other venous diseases of unknown origin.
- •Immunocompromised patients.
- •Dialysis patients.
- •Thalassemia patients.
- •Decompensated heart failure.
- •Pregnant and lactating women.
- •Any other recurrent illness or condition that, in the opinion of the investigator, would make the patient ineligible to participate in the trial.
结局指标
主要结局
Feasibility and Safety
Feasibility and Safety
次要结局
- 1.To determine the effect of the IMP on wound closure time compared to control group.2.To assess the effect of the IMP on the healing evolution of the lesion vs control group.3.To assess the effect of IMP on the concentration of GF closely related to wound healing.4.Evaluate the evolution of pain derived from the presence of UVs in the group treated with the IMP vs control group.5.To determine the perceived quality of life after treatment with the IMP vs control group.
研究者
Olga Fernández López
Scientific
Fundacion Progreso Y Salud
研究点 (2)
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