PMID- 38047294
OWN - NLM
STAT- MEDLINE
DCOM- 20231205
LR  - 20240222
IS  - 1533-1601 (Electronic)
IS  - 0192-6233 (Linking)
VI  - 51
IP  - 5
DP  - 2023 Jul
TI  - Scientific and Regulatory Policy Committee Technical Review: Biology and 
      Pathology of Ganglia in Animal Species Used for Nonclinical Safety Testing.
PG  - 278-305
LID - 10.1177/01926233231213851 [doi]
AB  - Dorsal root ganglia (DRG), trigeminal ganglia (TG), other sensory ganglia, and 
      autonomic ganglia may be injured by some test article classes, including 
      anti-neoplastic chemotherapeutics, adeno-associated virus-based gene therapies, 
      antisense oligonucleotides, nerve growth factor inhibitors, and aminoglycoside 
      antibiotics. This article reviews ganglion anatomy, cytology, and pathology 
      (emphasizing sensory ganglia) among common nonclinical species used in assessing 
      product safety for such test articles (TAs). Principal histopathologic findings 
      associated with sensory ganglion injury include neuron degeneration, necrosis, 
      and/or loss; increased satellite glial cell and/or Schwann cell numbers; and 
      leukocyte infiltration and/or inflammation. Secondary nerve fiber degeneration 
      and/or glial reactions may occur in nerves, dorsal spinal nerve roots, spinal 
      cord (dorsal and occasionally lateral funiculi), and sometimes the brainstem. 
      Ganglion findings related to TA administration may result from TA exposure and/or 
      trauma related to direct TA delivery into the central nervous system or ganglia. 
      In some cases, TA-related effects may need to be differentiated from a spectrum 
      of artifactual and/or spontaneous background changes.
FAU - Bennet, Bindu M
AU  - Bennet BM
AUID- ORCID: 0000-0003-1079-4505
AD  - Magenta Therapeutics, Cambridge, Massachusetts, USA.
FAU - Pardo, Ingrid D
AU  - Pardo ID
AD  - Biogen, Cambridge, Massachusetts, USA.
FAU - Assaf, Basel T
AU  - Assaf BT
AUID- ORCID: 0000-0003-2286-0303
AD  - Sanofi, Cambridge, Massachusetts, USA.
FAU - Buza, Elizabeth
AU  - Buza E
AUID- ORCID: 0000-0001-7044-3964
AD  - University of Pennsylvania, Philadelphia, Pennsylvania, USA.
FAU - Cramer, Sarah D
AU  - Cramer SD
AD  - StageBio, Frederick, Maryland, USA.
FAU - Crawford, LaTasha K
AU  - Crawford LK
AUID- ORCID: 0000-0002-8553-9894
AD  - University of Wisconsin-Madison, Madison, Wisconsin, USA.
FAU - Engelhardt, Jeffery A
AU  - Engelhardt JA
AD  - Ionis Pharmaceuticals, Carlsbad, California, USA.
FAU - Galbreath, Elizabeth J
AU  - Galbreath EJ
AUID- ORCID: 0000-0003-0162-8329
AD  - Independent Consultant, Lexington, Massachusetts, USA.
FAU - Grubor, Branka
AU  - Grubor B
AUID- ORCID: 0000-0003-2510-7499
AD  - Biogen, Cambridge, Massachusetts, USA.
FAU - Morrison, James P
AU  - Morrison JP
AUID- ORCID: 0000-0003-3975-1461
AD  - Charles River Laboratories, Inc., Shrewsbury, Massachusetts, USA.
FAU - Osborne, Tanasa S
AU  - Osborne TS
AD  - Novartis Pharmaceuticals, East Hanover, New Jersey, USA.
FAU - Sharma, Alok K
AU  - Sharma AK
AD  - Labcorp Drug Development, Madison, Wisconsin, USA.
FAU - Bolon, Brad
AU  - Bolon B
AUID- ORCID: 0000-0002-6065-1492
AD  - GEMpath Inc., Longmont, Colorado, USA.
LA  - eng
PT  - Journal Article
PT  - Review
PL  - United States
TA  - Toxicol Pathol
JT  - Toxicologic pathology
JID - 7905907
SB  - IM
MH  - Animals
MH  - *Ganglia, Spinal
MH  - *Nerve Fibers
MH  - Spinal Cord
MH  - Biology
OTO - NOTNLM
OT  - autonomic neuropathy
OT  - dorsal root ganglion
OT  - ganglion pathology
OT  - ganglion toxicity
OT  - peripheral neuropathy
OT  - sensory neuropathy
OT  - trigeminal ganglion
COIS- Declaration of Conflicting InterestsThe author(s) declared the following 
      potential conflicts of interest with respect to the research, authorship, and/or 
      publication of this article: The authors express no conflict of interest in 
      producing this technical review except that all are employed by organizations 
      involved in the discovery and development of various biomedical products for 
      treating human diseases (including AAV-based gene therapies, ASOs, other 
      neuroactive biologics, and small molecules).
EDAT- 2023/12/04 06:42
MHDA- 2023/12/05 12:42
CRDT- 2023/12/04 05:23
PHST- 2023/12/05 12:42 [medline]
PHST- 2023/12/04 06:42 [pubmed]
PHST- 2023/12/04 05:23 [entrez]
AID - 10.1177/01926233231213851 [doi]
PST - ppublish
SO  - Toxicol Pathol. 2023 Jul;51(5):278-305. doi: 10.1177/01926233231213851.