Johns Hopkins UniversityJohns Hopkins UniversityDepartment of NeurologyDepartment of Neurology
Location of skinLocation of skinbiopsies:biopsies:
To determineTo determineLength dependent neuropathyLength dependent neuropathy
Distal legDistal leg(lateral)(lateral)
Distal thighDistal thigh(lateral)(lateral)
Proximal thighProximal thigh(lateral)(lateral)
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Distal thigh biopsy:Distal thigh biopsy:10cm proximal to patella10cm proximal to patellaLateral aspectLateral aspect
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Grasp EDGE of deep dermisGrasp EDGE of deep dermisDo NOT touch epidermisDo NOT touch epidermis
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ImmunohistochemistryImmunohistochemistry
PGP9.5 PGP9.5 proteinprotein on on nervenerve
(antigen)(antigen)
RabbitRabbitAnti-PGPAnti-PGPantibodiesantibodies Goat anti-rabbit antibodiesGoat anti-rabbit antibodies
BLUE color!BLUE color!
NerveNerve
DermisDermis
EpidermisEpidermis
Stratum Stratum
corneumcorneum SensorySensory
nervesnerves
NormalNormalcontrolcontrol
LengthLengthdependentdependentdying backdying back
sensorysensoryneuropathyneuropathy
Intra-epidermalIntra-epidermalunmyelinatedunmyelinatedsensory nervesensory nerve
InnervatedInnervatedsweat glandssweat glands
autonomicautonomicfibersfibers
InnervatedInnervatedhair folliclehair follicle
andanderector pilli muscleerector pilli musclethermoregulationthermoregulation
DenervatedDenervatedHIVHIV
sweat glandssweat glandsdysautonomiadysautonomia
AutonomicAutonomicnervesnerves
next to anext to ablood vesselblood vessel
thermoregulationthermoregulation
Meissner’sMeissner’scorpusclecorpusclefine touch:fine touch:
shape, textureshape, texturedensitydensity
mechanoreceptormechanoreceptorproprioceptionproprioception
Johns Hopkins Cutaneous Nerve LabJohns Hopkins Cutaneous Nerve LabClinical lab for diagnostic purposesClinical lab for diagnostic purposes
CAP, JCAHO, CQI, CLIA, HIPAA, OSEH, training, parallel testingCAP, JCAHO, CQI, CLIA, HIPAA, OSEH, training, parallel testing
Pharmaceutical clinical trials research lab (multi-cohort center, Pharmaceutical clinical trials research lab (multi-cohort center, core lab)core lab)
DiabetesDiabetesHIV – USA, Uganda, ThailandHIV – USA, Uganda, ThailandAmyloid - InternationalAmyloid - InternationalSIV – Primate studies – HAART – D drugsSIV – Primate studies – HAART – D drugsLeprosy – India/Human – Louisiana/ArmadilloLeprosy – India/Human – Louisiana/ArmadilloToxic chemotherapeutic and HIV drugsToxic chemotherapeutic and HIV drugsInvestigators meetings, online technical protocol trainingInvestigators meetings, online technical protocol training
Basic research labBasic research labNerve degeneration and regenerationNerve degeneration and regenerationStereologic models, Confocal, EM, Palm Laser, Micro ArrayStereologic models, Confocal, EM, Palm Laser, Micro ArrayCapsaicin modelsCapsaicin modelsSIV - pigtail macaque and rhesus monkeysSIV - pigtail macaque and rhesus monkeysRestless leg, sclerodermaRestless leg, sclerodermaNIH, private, pharmaceutical fundsNIH, private, pharmaceutical fundsTransgenic animal modelsTransgenic animal models
Johns Hopkins Cutaneous Nerve LabJohns Hopkins Cutaneous Nerve LabClinical diagnostic labClinical diagnostic lab
Clinical licenses and monitoring through Dept of PathologyClinical licenses and monitoring through Dept of Pathology
Johns Hopkins Medical Laboratory – certified through Johns Hopkins Medical Laboratory – certified through Johns Hopkins Continuous Quality Improvement ProgramJohns Hopkins Continuous Quality Improvement Program
CLIA – 21D0709511CLIA – 21D0709511
MD State Licensed Medical Lab #471MD State Licensed Medical Lab #471
CAP certified lab LAP# 1353003, AU-ID# 1008616CAP certified lab LAP# 1353003, AU-ID# 1008616
HIPAA, Fire, Chemical Safety, DOT IATA shipping compliantHIPAA, Fire, Chemical Safety, DOT IATA shipping compliant
Pharmaceutical research labPharmaceutical research lab
FDA compliant - 21 CFR Part 11FDA compliant - 21 CFR Part 11
Core laboratory for all participating pharmaceutical studiesCore laboratory for all participating pharmaceutical studies
Study ConsiderationsStudy Considerations
Participating centers need to be properly Participating centers need to be properly trainedtrained
Lines of communication must be open Lines of communication must be open between centers, monitors and lab – Consider between centers, monitors and lab – Consider IVRS onlineIVRS online
Immediate feedback is importantImmediate feedback is important
Attention to detail – Quality Control for Attention to detail – Quality Control for biopsies and requisition formsbiopsies and requisition forms
Database management and data sets at Database management and data sets at study endstudy end