Johns Hopkins University Department of Neurology

Johns Hopkins Neurology Cutaneous Nerve Lab 30,000+ biopsies processed to date State of the art labs Clinical diagnostic Pharmaceutical research Basic science

Location of skin biopsies: To determine Length dependent neuropathy Distal leg (lateral) Distal thigh (lateral) Proximal thigh (lateral) * Distal thigh biopsy: 10cm proximal to patella Lateral aspect ----

Grasp EDGE of deep dermis Do NOT touch epidermis

**** &&&&

Immunohistochemistry PGP9.5 protein on nerve (antigen) RabbitAnti-PGPantibodies Goat anti-rabbit antibodies BLUE color! Nerve

Dermis Epidermis Stratum corneum Sensorynerves

Normalcontrol Lengthdependent dying back sensoryneuropathy

Intra-epidermalunmyelinated sensory nerve Innervated sweat glands autonomicfibers Innervated hair follicle and erector pilli muscle thermoregulation DenervatedHIV sweat glands dysautonomia Autonomicnerves next to a blood vessel thermoregulation Meissner’scorpuscle fine touch: shape, texture densitymechanoreceptorproprioception

Johns Hopkins Cutaneous Nerve Lab Clinical lab for diagnostic purposes CAP, JCAHO, CQI, CLIA, HIPAA, OSEH, training, parallel testing Pharmaceutical clinical trials research lab (multi-cohort center, core lab) Diabetes HIV – USA, Uganda, Thailand Amyloid - International SIV – Primate studies – HAART – D drugs Leprosy – India/Human – Louisiana/Armadillo Toxic chemotherapeutic and HIV drugs Investigators meetings, online technical protocol training Basic research lab Nerve degeneration and regeneration Stereologic models, Confocal, EM, Palm Laser, Micro Array Capsaicin models SIV - pigtail macaque and rhesus monkeys Restless leg, scleroderma NIH, private, pharmaceutical funds Transgenic animal models

Johns Hopkins Cutaneous Nerve Lab Clinical diagnostic lab Clinical licenses and monitoring through Dept of Pathology Johns Hopkins Medical Laboratory – certified through Johns Hopkins Continuous Quality Improvement Program CLIA – 21D MD State Licensed Medical Lab #471 CAP certified lab LAP# , AU-ID# HIPAA, Fire, Chemical Safety, DOT IATA shipping compliant Pharmaceutical research lab FDA compliant - 21 CFR Part 11 Core laboratory for all participating pharmaceutical studies

Study Considerations Participating centers need to be properly trained Lines of communication must be open between centers, monitors and lab – Consider IVRS online Immediate feedback is important Attention to detail – Quality Control for biopsies and requisition forms Database management and data sets at study end