Investigator-initiated clinical trials of bio 3D nerve conduit

JRCT ID: jRCT2053200022

Registered date:01/06/2020

Basic Information

• Recruitment status: Not Recruiting
• 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
• 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

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
• 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
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development