4.Unveiling the Complex World of Extracellular Vesicles: Novel Characterization Techniques and Manufacturing Considerations
James J. LAI ; John J. HILL ; Casey Y. HUANG ; Gino C. LEE ; Karol W. MAI ; Maggie Y. SHEN ; Simon K. WANG
Chonnam Medical Journal 2024;60(1):1-12
Extracellular vesicles (EVs) function as potent mediators of intercellular communication for many in vivo processes, contributing to both health and disease related conditions. Given their biological origins and diverse functionality from correspondingly unique “cargo” compositions, both endogenous and modified EVs are garnering attention as promising therapeutic modalities and vehicles for targeted therapeutic delivery applications. Their diversity in composition, however, has revealed a significant need for more comprehensive analytical-based characterization methods, and manufacturing processes that are consistent and scalable. In this review, we explore the dynamic landscape of EV research and development efforts, ranging from novel isolation approaches, to their analytical assessment through novel characterization techniques, and to their production by industrial-scale manufacturing process considerations. Expanding the horizon of these topics to EVs for in-human applications, we underscore the need for stringent development and adherence to Good Manufacturing Practice (GMP) guidelines. Wherein, the intricate interplay of raw materials, production in bioreactors, and isolation practices, along with analytical assessments compliant with the Minimal Information for Studies of Extracellular Vesicles (MISEV) guidelines, in conjunction with reference standard materials, collectively pave the way for standardized and consistent GMP production processes.
5.Implantation of Adipose-Derived Mesenchymal Stromal Cells (ADSCs)-Lining Prosthetic Graft Promotes Vascular Regeneration in Monkeys and Pigs
Xiao ZUO ; Pengfei HAN ; Ding YUAN ; Ying XIAO ; Yushi HUANG ; Rui LI ; Xia JIANG ; Li FENG ; Yijun LI ; Yaya ZHANG ; Ping ZHU ; Hongge WANG ; Ning WANG ; Y. James KANG
Tissue Engineering and Regenerative Medicine 2024;21(4):641-651
BACKGROUND:
Current replacement procedures for stenosis or occluded arteries using prosthetic grafts have serious limitations in clinical applications, particularly, endothelialization of the luminal surface is a long-standing unresolved problem.METHOD: We produced a cell-based hybrid vascular graft using a bioink engulfing adipose-derived mesenchymal stromal cells (ADSCs) and a 3D bioprinting process lining the ADSCs on the luminal surface of GORE-Tex grafts. The hybrid graft was implanted as an interposition conduit to replace a 3-cm-long segment of the infrarenal abdominal aorta in Rhesus monkeys.
RESULTS:
Complete endothelium layer and smooth muscle layer were fully developed within 21 days post-implantation, along with normalized collagen deposition and crosslinking in the regenerated vasculature in all monkeys. The regenerated blood vessels showed normal functionality for the longest observation of more than 1650 days. The same procedure was also conducted in miniature pigs for the interposition replacement of a 10-cm-long right iliac artery and showed the same long-term effective and safe outcome.
CONCLUSION
This cell-based vascular graft is ready to undergo clinical trials for human patients.
6.Explanation and interpretation of the compilation of neonatal blood transfusion in the national health standard "Guideline for pediatric transfusion".
Rong GUI ; Rong HUANG ; Ming-Hua YANG ; Xiao-Fan ZHU ; Jun LU ; Xiao-Jun XU ; Tian-Ming YUAN ; Rong ZHANG ; Xu WANG ; Jin-Ping LIU ; Jing WANG ; Zhi-Li SHAO ; Ming-Yi ZHAO ; Yong-Jian GUO ; Jia-Rui CHEN ; Qi-Rong CHEN ; Jia GUO ; Xin-Yin WU ; Ming-Yan HEI ; Qing-Nan HE
Chinese Journal of Contemporary Pediatrics 2024;26(12):1249-1254
In order to guide clinical blood transfusion practices for pediatric patients, the National Health Commission has released the health standard "Guideline for pediatric transfusion" (WS/T 795-2022). Considering the physiological particularities of the neonatal period, blood transfusion practices for neonates are more complex than those for other children, the guidelines include a separate chapter dedicated to neonatal blood transfusion. This paper interprets the background and evidence for the compilation of the neonatal blood transfusion provisions, hoping to aid in the understanding and implementation of the neonatal blood transfusion section of the guidelines.
Humans
;
Infant, Newborn
;
Blood Transfusion/standards*
;
Practice Guidelines as Topic
7.The first imported case of visceral leishmaniasis in Shenzhen City.
Chinese Journal of Schistosomiasis Control 2023;35(4):424-426
A patient with fever, chills, and pancytopenia as major clinical manifestations was presented. To investigate the cause, the patient's peripheral blood was collected for pathogen screening using metagenomic next - generation sequencing (mNGS). The DNA sequence of Leishmania donovani was detected, and Leishmania amastigotes were found in bone marrow smears using microscopy. The case was therefore definitively diagnosed as visceral leishmaniasis, and was cured and discharged from hospital following treatment with liposomal amphotericin B for 14 days. This is the first imported case of visceral leishmaniasis since the founding of Shenzhen City in 1979.
Humans
;
Fever
;
High-Throughput Nucleotide Sequencing
;
Leishmania donovani/genetics*
;
Leishmaniasis, Visceral/drug therapy*
8.Spatial distribution characteristics of the prevalence of advanced schistosomiasis and seroprevalence of anti-Schistosoma antibody in Hunan Province in 2020.
Y ZHOU ; L TANG ; Y TONG ; J HUANG ; J WANG ; Y ZHANG ; H JIANG ; N XU ; Y GONG ; J YIN ; Q JIANG ; J ZHOU ; Y ZHOU
Chinese Journal of Schistosomiasis Control 2023;35(5):444-450
OBJECTIVE:
To investigate the spatial distribution characteristics of the prevalence of advanced schistosomiasis and seroprevalence of anti-Schistosoma antibody, and to examine the correlation between the prevalence of advanced schistosomiasis and seroprevalence of anti-Schistosoma antibody in Hunan Province in 2020, so as to provide insights into advanced schistosomiais control in the province.
METHODS:
The epidemiological data of schistosomiasis in Hunan Province in 2020 were collected, including number of permanent residents in survey villages, number of advanced schistosomiasis patients, number of residents receiving serological tests and number of residents seropositive for anti-Schistosoma antibody, and the prevalence advanced schistosomiasis and seroprevalence of anti-Schistosoma antibody were descriptively analyzed. Village-based spatial distribution characteristics of prevalence advanced schistosomiasis and seroprevalence of anti-Schistosoma antibody were identified in Hunan Province in 2020, and the correlation between the revalence advanced schistosomiasis and seroprevalence of anti-Schistosoma antibody was examined using Spearman correlation analysis.
RESULTS:
The prevalence of advanced schistosomiasis was 0 to 2.72% and the seroprevalence of anti-Schistosoma antibody was 0 to 20.25% in 1 153 schistosomiasis-endemic villages in Hunan Province in 2020. Spatial clusters were identified in both the prevalence of advanced schistosomiasis (global Moran's I = 0.416, P < 0.01) and the seroprevalence of anti-Schistosoma antibody (global Moran's I = 0.711, P < 0.01) in Hunan Province. Local spatial autocorrelation analysis identified 98 schistosomiasis-endemic villages with high-high clusters of the prevalence of advanced schistosomiasis, 134 endemic villages with high-high clusters of the seroprevalence of anti-Schistosoma antibody and 36 endemic villages with high-high clusters of both the prevalence of advanced schistosomiasis and seroprevalence of anti-Schistosoma antibody in Hunan Province. In addition, spearman correlation analysis showed a positive correlation between the prevalence of advanced schistosomiasis and seroprevalence of anti-Schistosoma antibody (rs = 0.235, P < 0.05).
CONCLUSIONS
There were spatial clusters of the prevalence of advanced schistosomiasis and seroprevalence of anti-Schistosoma antibody in Hunan Province in 2020, which were predominantly located in areas neighboring the Dongting Lake. These clusters should be given a high priority in the schistosomiasis control programs.
Animals
;
Humans
;
Prevalence
;
Seroepidemiologic Studies
;
Schistosomiasis/epidemiology*
;
Schistosoma
;
Spatial Analysis
;
Antibodies, Helminth
;
China/epidemiology*
9.Preliminary application of recombinase -aided amplification in detection of Clonorchis sinensis metacercariae in freshwater fish.
J CHEN ; Z WANG ; W HUANG ; J WANG ; L CHEN ; Y SUN ; L ZHAO ; Y ZHAO ; Y QIAN ; J DUAN ; Q ZHANG
Chinese Journal of Schistosomiasis Control 2023;35(5):458-463
OBJECTIVE:
To evaluate the performance of recombinase-aided amplification (RAA) assay in detection of Clonorchis sinensis metacercariae in freshwater fish samples, so as to provide insights into standardization and field application of this assay.
METHODS:
Wild freshwater fish samples were collected in the rivers of administrative villages where C. sinensis-infected residents lived in Jiangyan District, Xinghua County and Taixing County of Taizhou City, Jiangsu Province from June to September 2022. Genomic DNA was extracted from six freshwater fish specimens (5 g each) containing 0, 1, 2, 4, 8 and 16 C. sinensis metacercariae for fluorescent RAA assay, and the diagnostic sensitivity was evaluated. Fluorescent RAA assay was performed with genomic DNA from C. sinensis, Metorchis orientalis, Haplorchis pumilio and Centrocestus formosanus metacercariae as templates to evaluate its cross-reactions. In addition, the detection of fluorescent RAA assay and direct compression method for C. sinensis metacercariae was compared in field-collected freshwater fish samples.
RESULTS:
Positive amplification was found in fresh-water fish specimens containing different numbers of C. sinensis metacercariae, and fluorescent RAA assay was effective to detect one C. sinensis metacercaria in 5 g freshwater fish specimens within 20 min. Fluorescent RAA assay tested negative for DNA from M. orientalis, H. pumilio and C. formosanus metacercariae. Fluorescent RAA assay and direct compression method showed 5.36% (93/1 735) and 2.88% (50/1 735) detection rates for C. sinensis metacercariae in 1 735 field-collected freshwater fish samples, with a statistically significant difference seen (χ2 = 478.150, P < 0.001). There was a significant difference in the detection of C. sinensis metacercariae in different species of freshwater fish by both the direct compression method (χ2 = 11.20, P < 0.05) and fluorescent RAA assay (χ2 = 20.26, P < 0.001), and the detection of C. sinensis metacercariae was higher in Pseudorasbora parva than in other fish species by both the direct compression method and fluorescent RAA assay (both P values < 0.05).
CONCLUSIONS
Fluorescent RAA assay has a high sensitivity for detection of C. sinensis metacercariae in freshwater fish samples, and has no cross-reactions with M. orientalis, H. pumilio or C. formosanus metacercariae. Fluorescent RAA assay shows a higher accuracy for detection of C. sinensis infections in field-collected freshwater fish than the direct compression method.
Animals
;
Clonorchis sinensis/genetics*
;
Metacercariae/genetics*
;
Recombinases
;
Fresh Water
;
Fishes
;
DNA
;
Fish Diseases/diagnosis*
10.Burden of hepatitis B-associated diseases in China from 1990 to 2030.
L YAO ; S LIN ; J HUANG ; Y WU
Chinese Journal of Schistosomiasis Control 2023;35(5):464-475
OBJECTIVE:
To measure the burden of hepatitis B-associated diseases in China from 1990 to 2019, and to predict its changes from 2020 to 2030.
METHODS:
The age-standardized prevalence, incidence, mortality and disability-adjusted life years (DALY) rate of hepatitis B-associated diseases in China from 1990 to 2019 were extracted from the Global Burden of Disease 2019 (GBD 2019) data resources, and the trends in burdens of hepatitis B-associated diseases were evaluated from 1990 to 2019 using estimated annual percentage change (EAPC) and annual percent change (APC). In addition, the changes in the burden of hepatitis B-associated diseases were predicted in China from 2020 to 2023 using the Bayesian model.
RESULTS:
The overall incidence of hepatitis B-associated diseases reduced from 2 725.98/105 in 1990 to 1 397.31/105 in 2019 in China [estimated annual percentage change (EAPC) = -2.35%, 95% confidential interval (CI): (-2.58%, -2.13%)], with a reduction in the prevalence from 12 239.53/105 in 1990 to 6 566.12/105 in 2019 [EAPC = -2.34%, 95% CI: (-2.54%, -2.14%)], a reduction in the mortality from 24.67/105 in 1990 to 8.07/105 in 2019 [EAPC = -4.92%, 95% CI: (-5.37%, -4.47%)], and a reduction in the DALY rate from 793.38/105 in 1990 to 247.71/105 in 2019 [(EAPC = -5.15%, 95% CI: (-5.64%, -4.66%)]. The DALY rate of hepatitis B-associated diseases were mainly attributed to liver cancer, and the DALY rate of hepatitis B-associated diseases appeared a tendency towards a rise in China from 2012 to 2019 [APC = 1.30%, 95% CI: (0.16%, 2.45%)]. The overall burden of hepatitis Bassociated diseases was higher in males than in females, and the DALY rate of hepatitis B-associated diseases increased with age, with the greatest DALY rate seen among patients at ages of 50 to 69 years. The overall incidence of hepatitis B-associated diseases was projected to be 866.79/105 in China in 2030, with the greatest incidence seen in acute hepatitis B (854.87/105), and the burden of hepatitis B-associated diseases was predicted to decline in China from 2020 to 2030; however, the burden of liver disease was projected to appear a tendency towards a rise.
CONCLUSIONS
The burden of hepatitis B-associated diseases appears an overall tendency towards a decline in China from 1990 to 2030; however, the burden of liver cancer appears a tendency towards aggravation. Early diagnosis and treatment of liver cancer should be given a high priority.
Male
;
Female
;
Humans
;
Middle Aged
;
Aged
;
Bayes Theorem
;
Quality-Adjusted Life Years
;
Hepatitis B/epidemiology*
;
Liver Neoplasms/epidemiology*
;
China/epidemiology*
;
Incidence

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