NCT00282685已完成1 期
(Restoration of Nerve Functions by Intra-arterial Transplantation of Bone Marrow Progenitor Cells in Patients With Diabetic Poly Neuropathy (PNP)
Johann Wolfgang Goethe University Hospital2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2005年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Improvement of neurological score: modified NIS(LL)+7
研究概览
简要总结
Treatment of patients with diabetic neuropathy by intraarterial progenitor cell transplantation.
详细描述
Goal is:
Stimulation of angiogenesis and induction of vasa nervorum in order to improve nerve function
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with distal symmetrical diabetic neuropathy of the legs
- •Type 1 or Type 2 Diabetes
- •Stable Glucose control over last 3 months (Hba1c <7.5)
- •Written informed consent
排除标准
- •Patients with peripheral arterial disease (ABI <0.9)
- •Neuropathy of other origin
- •Asymmetrical neuropathy
- •Active infection oder fever
- •Chronic inflammatory disease (z.B M. Crohn, Rheumatoid Arthritis)
- •HIV or hepatitis
- •Neoplastic disease without complete remission within last 5 y
- •Stroke or myocardial infarction within last 3 months
- •Renal failure (creatinine > 2 mg/dl)
- •Liver disease (GOT > 2 upper limit or spontaneous INR > 1,5).
- •Anemia (hemoglobine < 8.5 mg/dl)
- •Platelets <100.000/µl
- •HbA1c >7,5 %
- •Allergies to Aspirin, Clopidogrel, Heparin
- •Bleeding disorder
- •Surgery or trauma within the last 2 months
- •Pregnancy
- •Mental retardation
- •Participation in another study within 30 days
结局指标
主要结局
Improvement of neurological score: modified NIS(LL)+7
时间窗: 1 year
次要结局
- Modified Toronto Clinical Scoring System(1 year)
- Heart rate variability(1 year)
研究者
A. M. Zeiher
Prof. Dr. med.
Johann Wolfgang Goethe University Hospital
研究点 (2)
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