NCT04466007已完成2 期
Multicenter, Randomized, Dose-search, Parallel, Double-blind, and Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Intramuscular Administration of Allogeneic Adipose Tissue Adult Mesenchymal Stem Cells in Diabetic Patients With Critical Limb Ischemia Without Possibility of Revascularization
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz10 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年1月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 10
- 主要终点
- Complication rate after treatment administration
研究概览
简要总结
Phase II national, multicenter, double-blind, randomized, placebo-controlled, phase-3 clinical trial of 3 parallel groups.
详细描述
Disease or disorder under study: Critical ischemia of the lower limbs in diabetic patients without the possibility of revascularization.
Main valuation variable: Proportion of Adverse Events related to treatment.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet ALL of the following criteria to be included in the study:
- •Patients of both sexes.
- •Age between 40 and 90 years.
- •Severe grade vascular arteriosclerosis (category RB 4 and 5 mono or bilateral).
- •Impossibility of surgical or endovascular revascularization or failure in revascularization surgery performed, at least 30 days before inclusion in the study, defining failure as direct non-arrival of vessels to the plantar arch.
- •Normal biochemical parameters defined by:
- •Leukocytes> 3000 / mm3
- •Neutrophils> 1500 / mm3
- •Platelets> 100,000 / mm3
- •AST / ALT <2.5x upper limit of normal
- •In patients with an ischemic ulcer, it must be stable for at least 1 week.
- •Patients under conventional medical treatment for CLI.
- •Women of childbearing age must obtain a negative result in a urine pregnancy test performed at the time of inclusion in the study and commit to using an effective contraceptive method during their participation in the study.
- •Patients who have not participated in any other clinical trial during the 3 months prior to the inclusion visit.
- •Patients who sign the informed consent.
排除标准
- •Patients who present SOME of the following criteria may not be selected to participate in this study:
- •CLI with tissue loss in the target member (category 6 of RB).
- •Previous major amputation in the target member.
- •Uncontrolled hypertension (defined as PAS> 180 or PAD> 110 in at least 2 determinations during the selection period).
- •Patients with severe heart failure or ejection fraction less than 30%.
- •Patients with a previous diagnosis of ventricular arrhythmias or unstable angina.
- •Patients with septicemia.
- •Patients diagnosed with deep vein thrombosis in the 3 months prior to their inclusion in the study.
- •Concomitant therapy that includes hyperbaric oxygen, angiogenic agents or Cox II inhibitors.
- •Contraindication to perfusion NMR.
- •Proliferative retinopathy without treatment.
- •Diabetic nephropathy in hemodialysis.
- •Patients previously treated with cell therapy, gene therapy or growth factors in the last year.
- •Concomitant disease that limits life expectancy to 1 year or that does not ensure the follow-up period.
- •Patients who have suffered a stroke or myocardial infarction in the 3 months prior to the inclusion visit.
- •Severe anemia (hemoglobin <7.9g / dl) in the inclusion analysis.
- •Patients with a previous diagnosis of chronic alcoholism.
- •Any clinically significant anomaly detected in the Selection Period and which, in the opinion of the investigator, constitutes an impediment to the correct participation of the patient in the study or the fulfillment of the procedures established therein.
研究组 & 干预措施
Control arm
Placebo Comparator
0.9% physiological saline
干预措施: Placebos (Drug)
Low dose treatment arm
Experimental
Low dose allogeneic mesenchymal stem cells derived from adipose tissue
干预措施: Low dose allogeneic mesenchymal stromal cells (Drug)
High dose treatment arm
Experimental
High dose allogeneic mesenchymal stem cells derived from adipose tissue
干预措施: High dose allogeneic mesenchymal stromal cells (Drug)
结局指标
主要结局
Complication rate after treatment administration
时间窗: 1 year
次要结局
- Twin perimeter(1 year)
- % amputations(1 year)
- Wifi scale(1 year)
- Rutherford-Becker scale(1 year)
- Ankle arm index(1 year)
- Evaluation of vascularization though RMN(1 year)
- Temperature(1 year)
- Neuropathic symptoms (altered sensitivity)(1 year)
研究者
研究点 (10)
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