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 人待定
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- chronic discogenic low back pain.
- 发起方
- ATI tech pharmed
- 入组人数
- 5
- 状态
- 招募中
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
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
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
结局指标
主要结局
未指定
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