Evaluating Mechanically Engineered Stem Cell Exosomes for Treating Endometrial Injury: A Clinical Study

Summary

The goal of this clinical trial is to evaluate if engineered mechanically umbilical cord-derived stem cell exosomes, or conventional umbilical cord -derived stem cell exosomes, can improve endometrial thickness in women with thin endometrium. The main questions it aims to answer are: Can exosomes delivered via subendometrial injection improve endometrial thickness or clinical pregnancy rates compared to PRP (platelet-rich plasma)? Are there significant differences in endometrial thickness between the two treatment groups? Researchers will compare the intervention groups, which one group receives mechanical exosomes and the other receives conventional esosomes via subendometrial injection, to the control group, which receives PRP via the same methods, to see if exosomes provide superior therapeutic effects. Participants will: Receive either mechanical exosomesor or conventional esosomes or PRP through subendometrial injection. Be monitored for changes in endometrial parameters.

Timeline

Start

2025-02-21

Primary completion

2025-06-12

Completion

2027-03-31

Publications

• Results Zhang H, Zhu H, Feng J, Zhang Z, Zhang S, Wang Z, Sun L, Zhang W, Gao B, Zhang Y, Lin M. Reprogramming of Activated Pancreatic Stellate Cells via Mechanical Modulation of Transmembrane Force-sensitive N-cadherin Receptor. J Mol Biol. 2023 Jan 15;435(1):167819. doi: 10.1016/j.jmb.2022.167819. Epub 2022 Sep 8.
• Results Cheng B, Wan W, Huang G, Li Y, Genin GM, Mofrad MRK, Lu TJ, Xu F, Lin M. Nanoscale integrin cluster dynamics controls cellular mechanosensing via FAKY397 phosphorylation. Sci Adv. 2020 Mar 4;6(10):eaax1909. doi: 10.1126/sciadv.aax1909. eCollection 2020 Mar.
• Results Zhang Z, Sha B, Zhao L, Zhang H, Feng J, Zhang C, Sun L, Luo M, Gao B, Guo H, Wang Z, Xu F, Lu TJ, Genin GM, Lin M. Programmable integrin and N-cadherin adhesive interactions modulate mechanosensing of mesenchymal stem cells by cofilin phosphorylation. Nat Commun. 2022 Nov 11;13(1):6854. doi: 10.1038/s41467-022-34424-0.
• Results Zhang C, Zhu H, Ren X, Gao B, Cheng B, Liu S, Sha B, Li Z, Zhang Z, Lv Y, Wang H, Guo H, Lu TJ, Xu F, Genin GM, Lin M. Mechanics-driven nuclear localization of YAP can be reversed by N-cadherin ligation in mesenchymal stem cells. Nat Commun. 2021 Oct 28;12(1):6229. doi: 10.1038/s41467-021-26454-x.
• Results Sun H, Dong J, Fu Z, Lu X, Chen X, Lei H, Xiao X, Chen S, Lu J, Su D, Xiong Y, Fang Z, Mao J, Chen L, Wang X. TSG6-Exo@CS/GP Attenuates Endometrium Fibrosis by Inhibiting Macrophage Activation in a Murine IUA Model. Adv Mater. 2024 May;36(21):e2308921. doi: 10.1002/adma.202308921. Epub 2024 Apr 15.
• Results Zhang W, Tang R, Xiao X, Liu J, Li M, Wang X. A Comparative Study on the Efficacy of Subendometrial Versus Intrauterine Platelet-Rich Plasma Injections for Treating Intrauterine Adhesions: A Retrospective Cohort Study. J Minim Invasive Gynecol. 2025 Apr;32(4):378-385.e1. doi: 10.1016/j.jmig.2024.11.007. Epub 2024 Dec 4.

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