JPRN-jRCTb042210159招募中1 期
Safety study of LR-PRP administration for intervertebral disc in low back pain patients with Modic type 1 change
Fujita Noboyuki0 个研究点目标入组 10 人开始时间: 2022年3月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
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
- >= 20age old 至 < 70age old（—）
- 性别
- All
入选标准
- •1 Has participated in the Informed Consent process and is willing and able to sign an informed consent
- •2 aged 20 to 70 years old
- •3 Visual Analogue Scale (VAS) pain intensity 50mm or more for more than 3 months due to low back pain caused by intervertebral disc degeneration
- •4 Intervertebral disc degeneration with Modic type 1 change
- •5 Willing and able to complete scheduled follow-up evaluations as described in the study protocol
排除标准
- •1 BMI (Body Mass Index) : 30 or more
- •2 Has a blood dyscrasia (platelet (Plt) less than 50,000 /microliter)
- •3 Using anticoagulant or antiplatelet drug
- •4 Has an autoimmune disease
- •5 Has an active systemic inflammatory disease or infection
- •6 Has a polyarthralgia
- •7 Has an other spinal disease, including vertebral fracture
- •8 Has a compromised host status (diabetic, immune deficiency, chronic renal failure, hepatic cirrhosis, using immunosuppressive drug etc.)
- •9 Under treatment for malignant tumor
- •10 Is known to be pregnant
- •11 Judged as inappropriate subject by surgeons performing regenerative medicine
研究者
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