JPRN-jRCT2053200022进行中（未招募）未知
Safety and efficacy of bio 3D nerve conduit (B3CON-01) for peripheral nerve injury; investigator-initiated clinical trials - B3CO
Ikeguchi Ryosuke0 个研究点目标入组 3 人开始时间: 2020年6月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3
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 <= 60age old（—）
- 性别
- All
入选标准
- •1) severed peripheral nerve injuries or a defect in the region distal to the wrist joint not caused by a congenital anomaly;
- •2) a defect with a length of =<20 mm in a nerve with a diameter =<22 mm
- •3) failed results of sensory functional tests, including the Semmes -Weinstein monofilament test and static and moving 2-point discrimination sensory functional tests (s2PD and m2PD), for dermatome distribution of the injured peripheral nerve
- •4) able to register in the protocol within 6 months from the day of injury
- •5) refused artificial nerve or autologous nerve transplantation
- •6) age 20-60 years
- •7) willingness to participate and provide informed written consent
排除标准
- •1) peripheral nerve injury, including those in the fingers affected by infection and severe damage of accessories -including the skin, tendon, and bone- injury at multiple sites of the nerve and wide area, and direct suture-feasible
- •2) presence of antibodies against hepatitis B, human immunodeficiency, or human T-cell leukaemia virus
- •3) active infection, such as hepatitis C, syphilis (Treponema pallidum antibody-positive in serological tests for syphilis), and human parvovirus B19
- •4) a history of allergy or anaphylaxis reaction to a component(s) of the clinical trial products, such as aminoglycoside antibiotics, polyene macrolide antibiotics, bovine serum, and/or metal(s)
- •5) one of the following complications, including cardiovascular disease(s), diabetes mellitus, stroke (including history), cervical spondylosis, cervical myelopathy, polyneuropathy, Guillain-Barre syndrome, amyotrophic lateral sclerosis, peripheral circulatory failure, rheumatoid arthritis, collagen disease, depression, schizophrenia, automatic neuropathy, or dementia
- •6) malignant disease and/or medical history thereof
- •7) previous treatment with immunosuppressive agents and/or steroids excluding local effects
- •8) simultaneous participation in another interventional trial and/or a clinical trial within the previous 3 months before enrolment in this trial
- •9) history of participation in studies investigating the transplant of clinical trial products;
- •10) pregnant females, those lactating, and those unwilling to prevent pregnancy during the study period
- •11) individuals judged by the attending physician to be unfit or not suitable for the study
研究者
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