JRCT ID: jRCT2053200022
Registered date:01/06/2020
Investigator-initiated clinical trials of bio 3D nerve conduit
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | Peripheral nerve injury distal to the wrist joint that cannot be sutured directly |
Date of first enrollment | 25/12/2020 |
Target sample size | 3 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Bio 3D nerve conduit graft to a defect of a peripheral nerve |
Outcome(s)
Primary Outcome | Safety Incidence of adverse events that cannot be ruled out as related to investigational products or transplantation of investigational products, and skin tissue harvesting |
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Secondary Outcome | Effectiveness 1)Sensory functional results by SW test 48 weeks after the surgery 2)Sensory functional results by the two-point identification test 48 weeks after the surgery 1:Static two-point discrimination 2:Dynamic two-point discrimination |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | <= 60age old |
Gender | Both |
Include criteria | 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 |
Exclude criteria | 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 |
Related Information
Primary Sponsor | Ikeguchi Ryosuke |
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Secondary Sponsor | |
Source(s) of Monetary Support | Japan Agency for Medical Research and Development |
Secondary ID(s) |
Contact
Public contact | |
Name | Ryosuke Ikeguchi |
Address | 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, Japan Kyoto Japan 606-8507 |
Telephone | +81-75-366-7722 |
ikeguchi@kuhp.kyoto-u.ac.jp | |
Affiliation | Kyoto University Hospital |
Scientific contact | |
Name | Ryosuke Ikeguchi |
Address | 54 Kawahara-cyo,Shogoin,Sakyo-ku,Kyoto 606-8507,JAPAN Kyoto Japan 606-8507 |
Telephone | +81-75-366-7722 |
ikeguchi@kuhp.kyoto-u.ac.jp | |
Affiliation | Kyoto University Hospital |