Preclinical safety evaluation of WJMSCs and their secretome

Mesenchymal stem cells (MSC) are a promising therapy in regenerative medicine due to their unique ability to differentiate into other cells. Among established sources of MSC, MSC derived from Wharton’s jelly (WJSC) of an umbilical cord is a popular source since it involves a painless procedure to ob...

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Main Authors: Premasangery Kathivaloo, Subramani Parasuraman, Badrul Akmal Hisham Md Yusoff, Raziana Rasib, Karthik Chandran, Kathiresanv.Sathasivam
Format: Article
Language:English
Published: Penerbit Universiti Kebangsaan Malaysia 2025
Online Access:http://journalarticle.ukm.my/25721/
http://journalarticle.ukm.my/25721/1/SML%2010.pdf
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author Premasangery Kathivaloo,
Subramani Parasuraman,
Badrul Akmal Hisham Md Yusoff,
Raziana Rasib,
Karthik Chandran,
Kathiresanv.Sathasivam,
author_facet Premasangery Kathivaloo,
Subramani Parasuraman,
Badrul Akmal Hisham Md Yusoff,
Raziana Rasib,
Karthik Chandran,
Kathiresanv.Sathasivam,
author_sort Premasangery Kathivaloo,
building UKM Institutional Repository
collection Online Access
description Mesenchymal stem cells (MSC) are a promising therapy in regenerative medicine due to their unique ability to differentiate into other cells. Among established sources of MSC, MSC derived from Wharton’s jelly (WJSC) of an umbilical cord is a popular source since it involves a painless procedure to obtain the cord with an exceptional proliferation rate compared to other sources. However, the safety and efficacy of MSC must be confirmed through preclinical studies before clinical trials in humans. A study was designed to achieve the maximum tolerable dose (MTD) and safety and toxicity effects of WJSC and its secretomes in animal models. The MTD was achieved through acute toxicity testing on healthy female Sprague Dawley (SD) rats while the safety was assessed using a subchronic toxicity study on healthy male and female SD rats divided into four groups (control, low dose, medium dose and high dose). The safety assessments were then evaluated through biochemical, haematological, and histopathological analyses where the data obtained were analysed using a one-way ANOVA followed by Tukey’s test. Statistical analysis confirmed no significant differences in all tests performed in the study groups. At the study’s termination, neither cells nor secretomes injected rats were found to be deceased and no toxic or severe adverse effects were discovered. Thus, both WJSC and their secretomes applications in humans could be considered harmless for medical purposes.
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spelling oai:generic.eprints.org:257212025-08-07T02:14:15Z http://journalarticle.ukm.my/25721/ Preclinical safety evaluation of WJMSCs and their secretome Premasangery Kathivaloo, Subramani Parasuraman, Badrul Akmal Hisham Md Yusoff, Raziana Rasib, Karthik Chandran, Kathiresanv.Sathasivam, Mesenchymal stem cells (MSC) are a promising therapy in regenerative medicine due to their unique ability to differentiate into other cells. Among established sources of MSC, MSC derived from Wharton’s jelly (WJSC) of an umbilical cord is a popular source since it involves a painless procedure to obtain the cord with an exceptional proliferation rate compared to other sources. However, the safety and efficacy of MSC must be confirmed through preclinical studies before clinical trials in humans. A study was designed to achieve the maximum tolerable dose (MTD) and safety and toxicity effects of WJSC and its secretomes in animal models. The MTD was achieved through acute toxicity testing on healthy female Sprague Dawley (SD) rats while the safety was assessed using a subchronic toxicity study on healthy male and female SD rats divided into four groups (control, low dose, medium dose and high dose). The safety assessments were then evaluated through biochemical, haematological, and histopathological analyses where the data obtained were analysed using a one-way ANOVA followed by Tukey’s test. Statistical analysis confirmed no significant differences in all tests performed in the study groups. At the study’s termination, neither cells nor secretomes injected rats were found to be deceased and no toxic or severe adverse effects were discovered. Thus, both WJSC and their secretomes applications in humans could be considered harmless for medical purposes. Penerbit Universiti Kebangsaan Malaysia 2025 Article PeerReviewed application/pdf en http://journalarticle.ukm.my/25721/1/SML%2010.pdf Premasangery Kathivaloo, and Subramani Parasuraman, and Badrul Akmal Hisham Md Yusoff, and Raziana Rasib, and Karthik Chandran, and Kathiresanv.Sathasivam, (2025) Preclinical safety evaluation of WJMSCs and their secretome. Sains Malaysiana, 54 (5). pp. 1319-1330. ISSN 0126-6039 https://www.ukm.my/jsm/english_journals/vol54num5_2025/contentsVol54num5_2025.html
spellingShingle Premasangery Kathivaloo,
Subramani Parasuraman,
Badrul Akmal Hisham Md Yusoff,
Raziana Rasib,
Karthik Chandran,
Kathiresanv.Sathasivam,
Preclinical safety evaluation of WJMSCs and their secretome
title Preclinical safety evaluation of WJMSCs and their secretome
title_full Preclinical safety evaluation of WJMSCs and their secretome
title_fullStr Preclinical safety evaluation of WJMSCs and their secretome
title_full_unstemmed Preclinical safety evaluation of WJMSCs and their secretome
title_short Preclinical safety evaluation of WJMSCs and their secretome
title_sort preclinical safety evaluation of wjmscs and their secretome
url http://journalarticle.ukm.my/25721/
http://journalarticle.ukm.my/25721/
http://journalarticle.ukm.my/25721/1/SML%2010.pdf