NCT00765050终止1 期
A Prospective, Open, Non-randomized Phase I/II Study of Therapeutic Angiogenesis in Diabetic Patients With Critic Ischemia of Lower Limbs While Administering Positive CD133 Mobilized With G-CSF
PETHEMA Foundation5 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2009年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 5
- 主要终点
- analyze the safety and efficacy of CD133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs.
研究概览
简要总结
The primary objective is to analyze the safety and efficacy of CD133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs.
The secondary objectives are:
- To determine the safety of the intramuscular administration of CD133+ cells that have been mobilized from peripheral blood.
- To determine the CD133+ capacity to increase the re-vascularization at lower limbs in diabetic patients with critic ischemia in the lower limbs.
- To evaluate the patient global health condition using the notified results of the SF-36 questionnaires completed by patients
详细描述
A total of up to 20 diabetic patients with critic ischemia of lower limbs will be included in the study. Patients will be administered with CD133+ cells, that previously have been obtained of their peripheral blood after mobilization with G-CSF
The study is divided in three phases:
Pre-treatment (previous 4 weeks of CD133+ cells mobilization). Treatment (cells mobilization, CD133+ transplant, 24 hours after infusion visit, 4, 12 and 24 weeks after transplant visits) Follow-up (9 and 12 months after transplant visits)
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
- None
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
- •According to the investigator opinion, patient is able to carry out with all the clinical trial requirements
- •Patient must volunteer sign the inform consent before any study specific test, that is not part of the common patient attention, is performed. Patient must know that he/she can abandon the study at any time with no damage to his/her posterior attention
- •Age 18 to 75
- •A diagnosis of chronic critic ischemia of the lower limbs
- •Diabetes Mellitus active
- •III or IV stages (Fontaine classification): resting pain, ulcer or minor gangrene with no major amputation
- •General contraindication or local inoperability or refractory/progression after previous surgical treatment, according to the investigator criteria
- •If female reproductive potential, negative pregnancy test
排除标准
- •Pregnant or currently breast feeding women
- •Acute myocardial infarction within the last 3 years
- •Non re-vascular unstable angina pectoris
- •History of ischemia stroke within the last 3 years
- •Neoplasia at the time of inclusion or Chemotherapy or Radiotherapy treatment in the last 5 years
- •Chronic renal insufficiency
- •G-CSF contraindication
- •A non well controlled serious concomitant disease
- •History of serious thrombotic episodes within the past 3 years
- •Patients who have received other investigational therapy within 30 days previous to the study inclusion
- •Patients currently in other clinical trial or receiving any other investigational agent
结局指标
主要结局
analyze the safety and efficacy of CD133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs.
时间窗: 12 months
次要结局
- To determine the safety of the intramuscular administration of CD133+ cells that have been mobilized from peripheral blood(2 months)
- To determine the CD133+ capacity to increase the re-vascularization at lower limbs in diabetic patients with critic ischemia in the lower limbs(12 months)
- To evaluate the patient global health condition using the notified results of the SF-36 questionnaires completed by patients(12 months)
研究者
研究点 (5)
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