Peripheral nerve injury distal to the wrist joint th at can not be sutured directly Peripheral nerve, nerve regeneration, artificial nerve, autologous nerve graft, 3D nerve conduit
Conditions
Interventions
Tlans plantation, Surgery, Therapy
Sponsors
Ikrguchi Ryosuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 =18 years 7) willingness to participate and provide informed written consent
Exclusion criteria
Exclusion 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 2)direct suture-feasible 3)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) 4)one of the following complications, including diabetes mellitus(HbA1c (NGSP) =>6.5%), arteriosclerosis, polyarteritis nodosa, stroke (including history), cervical myelopathy, cervical spondylosis, polyneuropathy, Guillain-Barre syndrome, amyotrophic lateral sclerosis, peripheral circulatory failure, rheumatoid arthritis, collagen disease, depression, schizophrenia, automatic neuropathy, or dementia 5)malignant disease and/or medical history 6)treatment with immunosuppressive agents and/or steroids excluding local effects 7)simultaneous participation in another interventional trial and/or a clinical trial within the previous 3 months before enrolment in this trial 8)history of participation in studies investigating the transplant of clinical trial products 9)pregnant females, those lactating, and those unwilling to prevent pregnancy during the study period 10)individuals judged by the attending physician to be unfit or not suitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Incidence of adverse events that cannot be ruled out as related to investigational products or transplantation of investigational products, | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness 1)Sensory functional results by SW test 36 weeks after the surgery 2)Sensory functional results by the two-point identification test 36 weeks after the surgery 1: Static two-point discrimination 2: Moving two-point discrimination | — |
Contacts
Public ContactRosuke Ikeguchi
Kyoto University Hospital
Outcome results
None listed