Our pathology specialists support the construction of experimental analysis systems, data acquisition and explanation of results, and maximize the information from the histology samples of pharmacology studies conducted by clients.
List of evaluation items
With our expertise in inflammation and fibrosis, we will perform histopathological quantification and scoring for each tissue.
- Fibrosis evaluation
(alpha-SMA immunostaining, ER-TR7 immunostaining, Sirius red staining, Masson trichrome staining, etc.)
- Inflammation evaluation
(F4 / 80 immunostaining, Gr-1 immunostaining, CD4 immunostaining, etc.)
- Fat deposition evaluation
(Oil red staining)
- Cell proliferation / apoptosis evaluation
(Ki67 immunostaining, TUNEL staining, etc.)
- Human tissue evaluation
(HE staining, Sirius red staining, etc.)
Utilizing our expertise in fibrosis, we provide a fibrosis analysis method suitable for each disease model tissue.
Sirius red staining
Masson trichrome staining
SUMMARY OF SERVICE
Processing & Embedding :
- Embedding of human and animal tissues in paraffin (FFPE blocks) from fixed tissues.
- Embedding of human and animal tissues in OCT (frozen OCT embedded tissues) from fixed tissues.
- Instruction of fresh frozen block preparation for frozen sections.
- Cutting of sections (4-8 µm thick) from paraffin and O.C.T. embedded blocks.
- Preparation of serial thin sections.
- HE, Sirius red, Masson trichrome, PAS, Oil red, etc.
Immunohistochemistry (IHC): Inflammation-related molecules, fibrosis-related molecules etc.
- Functional Immunohistology（Double/multiple staining).
- New antibody staining protocol optimization & validation.
- Area, length, diameter, stained cell count, percentage positive area, shape etc.
- Proliferation, Apoptosis, pathological grading etc.
Interpretation of results:
- Discussion of the histological findings in view of pharmacology.
HISTOPATHOLOGY AND IMAGING SERVICES FOR MASH(f.k.a. NASH,hereinafter referred as MASH/NASH)
- Histopathological parameters are important endpoints in nonclinical as well as clinical studies in NASH and liver fibrosis.
SMC’s outstanding performance in MASH/NASH/liver fibrosis research:
- As a leading CRO in MASH/NASH, SMC has accumulated know-how by assessing over 500 pharmacology studies and 50,000 slides of MASH/NASH and related diseases in mouse, rat and human.
- judgment of NAS (especially, ballooning), assessment of pathological changes from disease control, discussion of clinical relevance… and more!
NAS; NAFLD Activity score
Assessment the grade of disease (MASH/NASH, fibrosis) in not only nonclinical pharmacology studies but also clinical studies.
Development of animal models (including Tg and KO mice) for drug evaluation in the clients’ own laboratory.
- Achievement of high quality report/data package with objective evaluation.
NAS: "BALLOONING" OR "PSEUDO-BALLOONING" ?
NAS (including ballooning, inflammation, steatosis) is an important parameter to evaluate the drug efficacy in MASH/NASH in both human and animal models.
In order to translate nonclinical results into clinical practice, it is essential to discriminate “true”- from “pseudo”-ballooning in disease models.
THE GRADE OF NAS: ACHIEVEMENT
An accurate scoring can evaluate the efficacy of the test substances on each components (steatosis, lobular inflammation, hepatocyte ballooning) of NAS.