Page 142 - Malaysian Journal of Health Promotion, Vol 4 (Supplementary 1) 2022

Malaysian Journal of Health Promotion, Vol 4 (Supplementary 1) 2022
rd
14 MOH-AMM Scientific Meeting 2022 in conjunction with 23 NIH Scientific Conference Abstract Book
th
polymorphisms (phenotyping or genotyping). This study compared adult and paediatric A1AT
concentration in multiple phenotypes.
METHODS: A1AT phenotype and quantitation were retrospectively analysed on adult (n=11)
and paediatric (n=58) samples between January to December 2021. A1AT was quantified on
Siemens Nephlometer and phenotype analysis was performed with isoelectric focusing and
immunofixation. A1AT concentration was measured and compared with different phenotype
between adults and children groups.
RESULTS: A total of 69 samples were analysed with six different phenotype consisting of M/M
(n=55), M/X (n=8), M variant (n=3), M/S (n=1), M/Z (n=1) and CM (n=1). These different
phenotypes were seen among the paediatric group and only two variant types (M/M and
M/X) were seen in adult group. A1AT level ranging from 0.85-2.69g/L and 1.08-1.99g/L was
found in paediatric and adults sample respectively. Paediatric A1AT level showed higher
quantitation in the M/X, M/M and CM phenotypes and two samples showed low A1AT level
in M/M phenotype. Adults A1AT level showed normal range in all phenotypes.
DISCUSSION/CONCLUSION: Increased concentrations of A1AT were associated with
phenotype M/X and CM meanwhile phenotype M/M was associated with decreased A1AT
level among paediatric population.

ID 187 PRECLINICAL TOXICITY STUDIES OF STEM CELL PRODUCTS FOR CANCER: A RAPID
REVIEW

Syazwani Sirdar Ali, Xin Yi Lim, Norizah Awang, Umi Rubiah Sastu@Zakaria, Nor Azlina Zolkifli, Suganthi Jeyabalan
Herbal Medicine Research Centre, Institute for Medical Research, National Institutes of Health, Ministry of
Health Malaysia

INTRODUCTION: There are rising demands to conduct Good Laboratory Practice (GLP)
compliant preclinical toxicity studies for cell therapy medicinal products (CTMPs). This review
was conducted to identify the characteristics of approved CTMPs in cancer management and
the preclinical toxicity studies that have been performed.
METHODS: We searched selected journal databases and grey literature to identify approved
CTMPs globally and its associated preclinical toxicity studies using predetermined keywords.
The outcome of interest includes product characteristics, indication, dose, registered country,
preclinical toxicity studies, and clinical studies.
RESULTS: Eighteen CTMPs approved in the U.S, Korea, and India are indicated for the use of
hematopoietic stem cell transplant and chemotherapy-related complications in cancer
treatment. Of these, only two have reported preclinical toxicity studies. These were in vitro
and in vivo tumorigenicity studies.
DISCUSSION/CONCLUSION: Most of the minimally-manipulated CTMPs (hematopoietic and
autologous) did not have explicit preclinical toxicity studies conducted while genetically
modified CTMPs were reported to have preclinical toxicity studies performed. Additional
preclinical safety data included for regulatory approval were derived from non-clinical
pharmacology studies. Nevertheless, all approved CTMPs were supported with clinical studies.
In conclusion, the regulatory requirements for preclinical toxicity studies varies for each
CTMPs.

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