NIPH Clinical Trials Search

Investigator-initiated clinical trial using human (allogeneic) bio 3D nerve conduit for peripheral nerve injury

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Peripheral nerve injury distal to the wrist joint th at can not be sutured directly
Date of first enrollment	05/01/2026
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,
Secondary Outcome	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

Key inclusion & exclusion criteria

Age minimum	> 18age old
Age maximum	Not applicable
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 =<2 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 =>18 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 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