The Efficacy and Safety of Peripheral Mobilized Mononuclear Cell-based Therapy in Patients With Diabetic Painful Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Changes in pain for a week after the procedure
研究概览
简要总结
To investigate the efficacy and safety of autologous peripheral blood stem cell based therapy in patients with diabetic painful neuropathy.
详细描述
Diabetic painful neuropathy a prevalent, disabling disorder. Currently, the only effective treatments are glucose control and pain management. Diabetic neuropathy is characterized by reduction of vascularity in peripheral nerves and deficiency in neurotrophic and angiogenic factors. Recent studies have shown that bone marrow (BM)-derived stem or progenitor cells have favorable effects on the repair of cardiovascular diseases. Since these BM-derived stem or progenitor cells contain various angiogenic and neurotrophic factors, these cells have been attempted for treating experimental diabetic neuropathy, and turned out to be effective for reversing various manifestations of experimental diabetic neuropathy.
However, stem-cell therapy was not proven in human study. Therefore, we will investigate the efficacy and safety of autologous peripheral blood stem cell injection in diabetic neuropathy.
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
- Single (Participant)
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
- •symptomatic diabetic neuropathy moderate pain more than 3 months Michigan Neuropathy Screening Instrument (MNSI) >3 3/day mean pain scale > NRS 4 Body weight >50 kg systolic blood pressure: 90-150 mmHg, Diastolic blood pressure <100 mmHg, Body temperature <37.5℃, Pulse rate: 50-100/min
排除标准
- •other cause of neuropathy symptomatic peripheral vessel disease skin lesion or arthritis central neuronal disease drug addiction or abuse Aspartate aminotransferase or Alanine aminotransferase >1.5 times than upper normal limit range Creatinine clearance rate <60ml/min or dialysis Myocardial infarction, unstable angina or heart failure diagnosed in 3 months psychologic disorder pregnancy or lactation
结局指标
主要结局
Changes in pain for a week after the procedure
时间窗: baseline, 4 week, 12 week
The pain scale was calculate by Numeric rating scale (NRS). We observe a change in NRS pain scores during the follow-up period.
次要结局
- The evaluation of changes in the specific neuro-sensory system(baseline, 4 week, 12 week)
研究者
Hye Seung Jung
Associate professor
Seoul National University Hospital