IRCT20080728001031N30招募中1 期
Safety evaluation of intra-discal transplantation of allogeneic clonal bone marrow derived mesenchymal stromal cells in patients with low back pain induced by degenerative disc disease: Interventional clinical trial, phase I
ATI tech pharmed0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 no limit（—）
- 性别
- All
入选标准
- •Age more than 18 years
- •both genders
- •mild to moderate intervertebral disc degeneration in one to three levels
- •Pfirrmann grade 3 to 6 (annulus fibrosus is able to maintain cell transplantation)
- •Modic grade II or less in magnetic resonance imaging (MRI) with or without disc bulging
- •lumbar pain visual analogue scale (VAS) : 3-9
- •back pain > radiculopathy
- •Oswestry disability index (ODI):30-90
- •decrease in intervertebral disc height< 30%
- •central disc bulging
- •chronic back pain (atleast for three months in the last six months) which did not respond to symptomatic treatments including physical therapy and medication
- •informed written consent
排除标准
- •body mass index (BMI)>35 kg/m2
- •Kellgren Knee osteoarthritis grading 3 or more
- •inherited or acquired disease leading to spine deformation,which will impede cell transplantation
- •segmental instability of spine, spine canal stenosis, spondylitis, spondylolisthesis ,other spondyloarthropathies and other diseases that might interfere with the study
- •prior history of disc surgery at the involved or adjacent levels
- •any type of infections or lesions at the site of injection
- •any issue in injection site that may make injection technically impossible
- •prior history of intra-discal injection
- •history of any type of epidural injection in the previous three months
- •any type of neoplasm
- •immuno-compromised or under treatment with immmuno-suppressant agents
- •disrupted hematological or biochemical laboratory results that causes contraindications for the invervention
- •any type of coagulopathy or hemorrhagic diseased or treatment with anticoagulants
- •positive viral tests for HIV, CMV, HCV, HBV, HTLV 1&2
- •history or clinical diagnosis of severe osteoporosis
- •known uncontrolled co-morbidities eg. diabetes(HbA1C>8%) or organ failure, liver (AST,ALT>100 U/L) kidney (Cr>2) and heart (EF<45%)
- •movement disorders
- •thyroid hormones disruption
- •pregnancy or breast feeding
- •opium or alcohol abuse
- •history or clinical diagnosis of any type of psychosis
- •allergy to substances that exist in culture media eg. gentamycin, bovine or horse serum
研究者
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