Evidence mapPaperPMID 38828201Full record

ArticleInternational journal of nanomedicine2024

Non-Clinical Safety Evaluation of Exosomes Derived from Human Umbilical Cord Mesenchymal Stem Cells in Cynomolgus Monkeys.

Xin-Mei Hu, Can-Can Wang, Yu Xiao, Yu Liu, Hong-Ri Huang, Peng Jiang, Ying-Kai Wang, Yun-Jin Lin, Liang-Cheng Li, Zhong-Quan Qi

Abstract read
In one paragraph

Article in International journal of nanomedicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Xin-Mei Hu *Medical College, Guangxi University, Nanning, Guangxi Zhuang Autonomous Region, People's Republic of China.
Can-Can Wang *Medical College, Guangxi University, Nanning, Guangxi Zhuang Autonomous Region, People's Republic of China.ORCID 0009-0006-4867-572X
Yu XiaoMedical College, Guangxi University, Nanning, Guangxi Zhuang Autonomous Region, People's Republic of China.
Yu LiuMedical College, Guangxi University, Nanning, Guangxi Zhuang Autonomous Region, People's Republic of China.
Hong-Ri HuangDepartment of Research and Development, Guangxi Taimei Rensheng Biotechnology Co., Ltd, Nanning, Guangxi Zhuang Autonomous Region, People's Republic of China.
Peng JiangMedical College, Guangxi University, Nanning, Guangxi Zhuang Autonomous Region, People's Republic of China.
Ying-Kai WangMedical College, Guangxi University, Nanning, Guangxi Zhuang Autonomous Region, People's Republic of China.
Yun-Jin LinMedical College, Guangxi University, Nanning, Guangxi Zhuang Autonomous Region, People's Republic of China.
Liang-Cheng LiSchool of Pharmaceutical Sciences, Xiamen University, Xiamen, Fujian Province, People's Republic of China.
Zhong-Quan QiMedical College, Guangxi University, Nanning, Guangxi Zhuang Autonomous Region, People's Republic of China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: In recent years, exosomes have been proved to be used to treat many diseases. However, due to the lack of uniform quality control standards for exosomes, the safety of exosomes is still a problem to be solved, especially now more and more exosomes are used in clinical trials, and its non-clinical safety evaluation is particularly important. However, there is no safety evaluation standard for exosomes at present. Therefore, this study will refer to the evaluation criteria of therapeutic biological products, adopt non-human primates to evaluate the non-clinical safety of human umbilical cord mesenchymal stem cell exosomes from the general pharmacology and immunotoxicity, aiming at establishing a safety evaluation system of exosomes and providing reference for the clinical application of exosomes in the future. Methods: 3.85 × 10 Results: The results showed that exosomes did not have obvious pathological effects on the general clinical conditions, blood, coagulation function, organ coefficient, immunoglobulin, Th1/Th2 cytokines, lymphocytes, major organs, and major immune organs (spleen, thymus, bone marrow) of cynomolgus monkeys. However, the number of granulocyte-macrophage colonies in exosomes group was significantly higher than that in control group. Conclusion: To sum up, the general pharmacological results and immunotoxicity results showed that the injection of 3.85 × 10

Indexed as

ExosomesMacaca fascicularisMesenchymal Stem CellsUmbilical CordAnimalsCytokinesFemaleHumansMaleCytokinescynomolgus monkeysexosomesimmunotoxicitysafety

Identifiers

PMID38828201
PMCPMC11143447

What Socratic holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.