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- Title
Pre-clinical Safety Study of Wharton's Jelly-derived Mesenchymal Stem Cells Delivered via Systemic Administration.
- Authors
Chan Man Lung, Alvin; Ng Min Hwei, Angela; Yunus, Mohd Heikal Mohd; Idrus, Ruszymah Hj Bt; Jia Xian, Law; Yazid, Muhammad Dain; Chin Kok-Yong; Shamsuddin, Sharen Aini; Yusof, Mohd Rafizul Mohd; Afandi, Mohd Asyraf Mat; Hassan, Muhammad Najib Fathi; Ng See Nguan; Koh, Benson; Lokanathan, Yogeswaran
- Abstract
Introduction: Mesenchymal stem cells (MSC) are unique adult cells with a large regenerative and immunomodulatory capacity with extended effects through the secretion of functional metabolites. The inconsistencies in safety results reported have prevented the clinical translation of MSC therapies. In an animal model, we conducted a study to determine the safety of Wharton's Jelly derived mesenchymal stem cell (WJ-MSC) via the intravenous route. Methods: This study was approved by the Animal Ethics Committee of the Faculty of Medicine, Universiti Kebangsaan Malaysia (TEC/FP/2020/YOGESWARAN/23-SEPT./1124-OCT.-2020-SEPT-2023). Healthy male Sprague Dawley rats were randomly assigned into two groups that received a single, pre-determined high-dose of WJ-MSC or saline. Physical measurements, blood analysis (serum chemistry and whole blood profile), and the signs of morbidity and mortality were observed throughout the study. Acute and sub-chronic toxicity was performed at 14 and 90 days, respectively. Upon euthanasia, necropsy and histology of primary organs (lung, liver, spleen and kidneys) were performed. Results: The physical measurements, blood analysis and signs of morbidity and mortality were not statistically significantly different (P<0.05) between the treatment and control groups. The necropsy and histopathology revealed minor pulmonary inflammation of the lungs in animals of both groups. Recovery was observed in the treatment group at both terminal stages. Regrettably, the source of inflammation was not identified. Discussion: No significant differences (P<0.05) were drawn from comparing the physical, biochemistry, and haematological profiles between MSC and the control group. Furthermore, microanatomical structures in inflamed alveolar and bronchial regions of lungs recovered in MSC-treated animals and improved over time. These changes were not observed in the control group even after 12 weeks. Thus, we hypothesize that the systemically infused WJ-MSC alleviated inflammatory symptoms in the lungs instead of the animals' natural recovery. Conclusion: The intravenous administration of WJ-MSC was safe with no adverse or side effects in the animal model.
- Subjects
MESENCHYMAL stem cells; UNIVERSITI Kebangsaan Malaysia (Bandar Baru Bangi, Malaysia); SPRAGUE Dawley rats; BLOOD testing; AUTOPSY; BIOCHEMISTRY
- Publication
Malaysian Journal of Medicine & Health Sciences, 2022, Vol 18, p3
- ISSN
1675-8544
- Publication type
Abstract