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Johns Hopkins University Department of Neurology. Skin Biopsy Technique for Cutaneous Nerve Evaluation. Biogen Idec 103NS201 Neublastin Trial. Why Skin?. Johns Hopkins Cutaneous Nerve Laboratory
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Johns Hopkins University Department of Neurology Skin BiopsyTechnique for Cutaneous Nerve Evaluation Biogen Idec 103NS201 Neublastin Trial
Johns Hopkins Cutaneous Nerve Laboratory • First CLIA / JCAHO / CAP certified clinical lab for epidermal quantitation – 35,000+ biopsies processed • Validated direct measure of axonal integrity • Demonstrated that epidermal nerve fibers are lost early in PN disease • Therefore often more sensitive than nerve conduction • IGT (pre-diabetes), HIV infection, amyloid, idiopathic neuropathy, CIPN • Core Laboratory for over one dozen multicenter clinical trials • Developed efficient models of nerve regeneration using injury models • Efficient safety measure of potential toxicity
The following items will be supplied by the central laboratory for the skin punch biopsies: • • Sterile disposable 3mm skin punch • • Sterile disposable forceps • • Sterile disposable scalpel • • Zamboni’s fixative solution (individual pre-filled tubes) • • Phosphate buffer (individual pre-filled tubes) • • Cryoprotectivesolution (individual pre-filled tubes) • • Sample vials • • Requisition form • • Parafilm(for securely sealing the sample vial) • • Template for biopsy site locations (1 per subject) • • Easy to follow reference sheet • • Cooler shipping box and ice pack
Biopsy Precautions Check with patient regarding allergies to lidocaine or adhesives Do not biopsy distal to, or on surgical site or scar tissue Do not stretch skin while performing punch biopsy Do not grasp across the entire superficial dermis or any epidermis Do not allow tissue to dry out at any time, place in fix immediately Fix for 6-24 hrs in refrigerator-do not freeze! Do not crush biopsy while screwing on tube cap Carefully fill out all associated paperwork, double checking tube labels and biopsy requisition forms!
PGP9.5 Immunohistochemistry Stratum corneum Sensory nerves Epidermis Dermis
All centers should evaluate their biopsies at the time of biopsy…