Study of Mechanically Engineered and Conventional Umbilical Cord Stem Cell Exosomes Compared to Platelet-Rich Plasma to Improve Thin Endometrium in Women with Intrauterine Adhesions

What This Trial Is About

Researchers are evaluating whether engineered mechanically umbilical cord-derived stem cell exosomes or conventional umbilical cord-derived stem cell exosomes can improve the thickness of the endometrium in women with thin endometrium caused by severe intrauterine adhesions after hysteroscopic adhesiolysis. The study aims to compare the effectiveness of these exosomes versus platelet-rich plasma PRP, a commonly used treatment, in improving endometrial thickness and pregnancy outcomes. This clinical trial is prospective, non-randomized, and parallel-controlled, focusing on regenerative therapies for reproductive medicine challenges like recurrent implantation failure and pregnancy complications. Participants are divided into three groups receiving different treatments via hysteroscopically guided intra-endometrial injection during the proliferative phase Day 3-7 of the menstrual cycle. One group receives mechanically engineered umbilical cord mesenchymal stem cell-derived exosomes ME-UCMSC-Exo, another receives conventional umbilical cord mesenchymal stem cell-derived exosomes UCMSC-Exo, and the control group receives autologous PRP. Each injection delivers 1 to 1.5 mL of the respective treatment. The study evaluates whether mechanical preconditioning of exosomes enhances their regenerative effects compared to conventional exosomes and PRP. Participants will be monitored before treatment and at multiple follow-up points including during embryo transfer cycles and pregnancy assessments up to one year post-intervention. Researchers will measure changes in endometrial thickness, clinical pregnancy rates, implantation rates, live births, and miscarriage rates while monitoring safety through adverse reaction tracking and evaluations of organ function and tumor markers. Total participation includes treatment and follow-up visits over a period extending to one year after intervention.

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