Effect Of Mesenchymal Stem Cells Transfusion on the Peripheral Neuropathy in Diabetic Patients Measured by Nerve Conduction.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Change of Nerve Conduction Amplitude of Nerves Affected Measured by Nerve Conduction Study.
研究概览
简要总结
A debilitating consequence of diabetes mellitus (DM) is neuropathy which globally affects between 20 -30% of diabetic patients and up to 50% in other studies. The incidence of diabetic neuropathy (DN) is estimated to be up to 45% for type 2 diabetic patients and 59% for type 1diabetic patients in USA.(DN) is the most common complication of DM.The pathophysiology of DN is promoted by several risk factors: micro vascular disease, neural hypoxia, and hyperglycemia-induced effects.At the molecular level, the primary cause of diabetic complications is known to be hyperglycemia, which disrupts cellular metabolism by the formation of reactive oxygen species (ROS).In the aspect of nerve functions, ROS formation increases neuron's susceptibility to damage. In addition, hyperglycemia impedes production of angiogenic and neurotrophic growth factors, which are necessary for normal function of neurons and glial cells and maintenance of vascular structure.No definitive disease-modifying treatments have been to reverse DN. The current treatment focuses on tight glycemic control which can reduce potential risk factors for further nerve damage and DN-associated pain management.In many studies, deficiency of neurotrophic factors and lack of vascular support have been regarded as key factors in the development DN.Mesenchymal stem cells (MSCs) are particularly attractive therapeutic agents because of their ability to self-renew, differentiate into multi lineage cell types, and locally secrete angiogenic cytokines, including basic fibroblast growth factor (bFGF) and vascular endothelial growth factor (VEGF) .These factors were reported to prompt neovascularization and have support for neural regeneration.It was plausible that MSCs may also be an effective therapeutic agent for the DN treatment through the paracrine effects of bFGF (Shibata et al., 2008) and VEGF and their potential to differentiate into neural cells such as astrocytes, oligodendrocytes , and Schwann cells.The adherent nature of MSCs makes them easy to expand in culture and an attractive candidate to use in cell therapy.Therefore, cell therapy has recently emerged as an attractive therapeutic strategy to meet the needs of both neurotrophic and vascular deficiencies of DN.Proper diagnosis of DN depends on the pattern of sensory loss, reflex test, electrodiagnostic studies, and imaging
详细描述
Objectives This study will be conducted to investigate the effects of Mesenchymal stem cells (MSC) transfusion on diabetic peripheral neuropathy in diabetic patient. (MSCs) have been reported to secrete various cytokines that exhibit angiogenic and neuro supportive effects.
Study Design Experimental interventional study. phase II clinical trial
Ethical committee approval (was it ethically approved by the department) Internal medicine department Yes
Study Methods
Population of study & disease condition (e.g women with hepatitis, .........) Diabetic patients(type I, type II) with documented peripheral neuropathy as determined by impaired nerve conduction
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 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(Type I, type II) diabetic patients age range (18-45) years, with diabetic peripheral neuropathy proved by clinical assessment and nerve conduction who did not receive treatment for diabetic peripheral neuropathy.
排除标准
- •Decompensated cardiac, renal or liver disease. Associated autoimmune diseases Associated endocrinal diseases Pregnancy, usage of contraceptive pills or steroids.
研究组 & 干预措施
mesenchymal stem cells
The BM aspirate will be diluted at 6:1 ratio with phosphate buffer saline with 2 ml EDTA (30 ml BM aspirate+ 5 ml PBS/EDTA buffer).MNCs will be separated under aseptic conditions using a Ficoll. Hypaque desity gradient by centrifugation at 1800 rpm for 20 min then the MNCs will be plated in 40 ml(αMEM), serum free media; mesencult(MSCs culture),penicillin (100 U/ml),streptomycin(10 mg/ml),0.5 ml amphotericin B(all from Gibco BRL) and 10 ng/ml basic fibroblast growth factor (b-FGF)(R&D system, Minneapolis, MN) and will be incubated at 370 c in a humidified atmosphere containing 5% CO2 .after one day ,nonadherent cells will be cultured in the presence of Mesenchymal media for 3 weeks changed every week. After reaching 80% confluence the MSCs will be placed in 10 ml saline and infused IV.
干预措施: mesenchymal stem cells (Genetic)
结局指标
主要结局
Change of Nerve Conduction Amplitude of Nerves Affected Measured by Nerve Conduction Study.
时间窗: base line(zero dya), 90 days after stem cells transfusion
Measuring nerve conduction amplitudes in uv of upper and lower limbs nerves(sensory and motor). lower limb nerves : tibial , common peroneal(CP) as motor and sural nerve as sensory . upper limb nerves: ulnar nerve as motor and sensory. and compare at base line and 90 days after stem cells transfusion
Measurement of b-FGF, v-EGF MEASURED BY ELISA
时间窗: zero ( before) , 7 DAYS, 90 days
measurement of b-FGF and v-EGF MEASURED BY ELISA before (at zero), and after at (7 days, 90) days after stem cell transfusion to measure the effect of stem cell and its role in nerve regeneration
Change of Nerve Conduction Velocities of Nerves Affected Measured by Nerve Conduction Study.
时间窗: base line(zero dya), 90 days after stem cells transfusion.
Measuring nerve conduction velocities(NCV) in m/sec upper and lower limbs nerves(sensory and motor) lower limb nerves : tibial , common peroneal(CP) as motor and sural nerve as sensory upper limb nerves: ulnar nerve as motor and sensory and compare at base line(zero day) and 90 days after stem cells transfusion
Change of Nerve Conduction Latency of Nerves Affected Measured by Nerve Conduction Study
时间窗: base line(zero dya), 90 days after stem cells transfusion .
Measuring nerve conduction latency in msec of upper and lower limbs nerves(sensory and motor) lower limb nerves : tibial , common peroneal(CP) as motor and sural nerve as sensory upper limb nerves: ulnar nerve as motor and sensory and compare at base line and 90 days after stem cells transfusion
次要结局
- Change of Levels of Glycated Haemoglobin( HA1C) After Stem Cells Transfusion Measured in Percent %(at base line (zero day) and 90 days after stem cells transfusion)
- Change of Levels of Fasting Blood Sugar and 2 Hours Post Prandial at Base Line ( Zero Day ) and After (90 Days) After Stem Cells Transfusion(base line (zero day) and 90 days after stem cells transfusion)
研究者
dina mohammed riad
Assistant Lecturer of Internal Medicine,faculty of medicine,Kasr Al Ainy hospital
Cairo University
