JPRN-jRCTb032220281招募中1 期
Clinical trial on treatment of osteoarthritis using chondrocyte spheroids differentiated from adipose-derived mesenchymal stem cells - Clinical trial on osteoarthritis using chondrocyte spheroids differentiated from adipose-derived mesenchymal stem cells
Hayashi Shuji0 个研究点目标入组 20 人开始时间: 2022年8月19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
- 20
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 < 80age old（—）
- 性别
- All
入选标准
- •1) KL Grade I or higher osteoarthritis patients
- •2) Patient who have pain (VAS>4) at the target site more than 3 months before the date of consent
- •3) Men and women whose consent acquisition date is more than 20 years and less than 80 years
- •4) Patients who can appropriately evaluate pain from start of screening to the end of observation for 48 weeks
- •5) Patients who have received sufficient explanation using ICF and understand the contents, and who have obtained written consent to participate in the study group based on their free will
- •6) Patients who can follow the scedule established until the end of the examination period
排除标准
- •1) Patients with pain other than the primary disease corresponding to any of the following within 7 days before the first administration day-Pain other than the target site suring the screening period average 4 or more (Lumbar spinal canal stenosis, etc.)
- •2) Patients who have inflammatory diseases other than synovitis due to the primary disease at the target site on the screening test day or the first administration day, or patients with a history of these diseases within one year before obtaining consent
- •3) Patients who have undergone surgical procedures including arthroscopy for the disease site (exclucding drainage of joint fluid)
- •4) Patients who received physical therapy of the primary disease within 28 days before the screening start date
- •5)Patients with a history or complication of malignancy within 5 years before obtaining consent
- •6) Patients with the following symptoms or diseases that may affect the results
- •-patients with severe heart disease, liver disease, kidney disease, blood disease or immunodeficiency
- •-patients with systemic joint disease such as rheumatoid arthritics and gout
- •-patients with peripheral neuropathy
- •-patients with osteonecrosis of the disease site
- •-patients with mental illness such as depression, dementia, schizophenia and anxiety
- •-patients scheduled for surgery during the period from the date of consent to the end of observation for 12 months
- •7) Patients who have a history or complication of drug dependence or alcoholism
- •8) Patients iudged inappropriate by doctors
研究者
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