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

ConditionsThin Endometrial Lining Female Infertility Intrauterine Adhesions

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexFemale

Age20-40

SponsorTang-Du Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Females aged 20-40 years (inclusive of boundary values);

Normal ovarian reserve function (criteria: AFC ≥ 7, AMH > 1.1 ng/mL);

History of transcervical resection of adhesions (TCRA);

Received PRP treatment after TCRA;

Disqualifiers

Patients with severe systemic diseases, surgical contraindications, or cycle contraindications;

Patients with reproductive tract infections, genital tuberculosis, pelvic inflammatory disease, or malignant tumors of reproductive organs;

Patients with systemic diseases that cause uterine bleeding;

Patients allergic to any drugs, materials, or components used in this study;

Trial design

Design model

Parallel

Treatments tested in this trial

Mechanically Engineered Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes
Biological/Vaccine
Mechanically engineered umbilical cord mesenchymal stem cell-derived exosomes (ME-UCMSC-Exo) are isolated from umbilical cord-derived mesenchymal stem cells (UCMSCs) subjected to mechanical stress conditioning during in vitro expansion. This process enhances exosome yield, bioactivity, and regenerative capacity. The exosomes are purified via ultracentrifugation and characterized for size, protein markers, and RNA content. In this study, ME-UCMSC-Exo is administered via intra-endometrial injection under hysteroscopic guidance. Each participant in this intervention group will receive 1-1.5 mL of exosome solution (containing approximately5\*10\^10 particles/mL) per injection site during the proliferative phase (Day 3-7 of the menstrual cycle). The aim is to enhance endometrial thickness, receptivity, and pregnancy outcomes in patients with thin endometrium secondary to intrauterine adhesions.
Umbilical cord mesenchymal stem cell-derived exosomes
Biological/Vaccine
Umbilical cord mesenchymal stem cell-derived exosomes (UCMSC-Exo) are obtained from standard cultured UCMSCs without mechanical stress preconditioning. These exosomes undergo identical purification and characterization procedures as ME-UCMSC-Exo but lack biomechanical priming. UCMSC-Exo is also administered intra-endometrially via hysteroscopic injection at a dose of 1-1.5 mL (5\*10\^10 particles/mL) per site.
platelet-rich plasma
Biological/Vaccine
Platelet-rich plasma (PRP) is an autologous biological preparation obtained from centrifuged whole blood. It contains a high concentration of growth factors, including platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-β), and vascular endothelial growth factor (VEGF), which promote endometrial regeneration. In this study, PRP will be administered via hysteroscopically guided intra-endometrial injection at a dose of 1-1.5 mL per injection site, following standard PRP preparation protocols. This group serves as a positive control for evaluating the efficacy of exosome-based therapies.

Treatment groups

90 Participants

are divided into 3 treatment groups

Group A: Mechanically Engineered Umbilical Cord Mesenchymal Stem Cell-Derived Exosome Group (ME-UCMSC-Exo)Experimental treatment 1 intervention

Group B: Conventional Umbilical Cord Mesenchymal Stem Cell-Derived Exosome Group (UCMSC-Exo)Experimental treatment 1 intervention

Group C: Platelet-Rich Plasma (PRP) Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Endometrial thickness

The endometrial thickness under ultrasound is measured on the HCG trigger day, oocyte retrieval day, day of progesterone Initiationor or embryo transfer day using transvaginal ultrasound in the sagittal/long-axis plane of the uterus. The measurement is taken at the thickest point within a 1 cm range from the uterine fundus, from the basal membrane on one side, perpendicular across the endometrial cavity line to the basal membrane on the opposite side.

Time frame

30-90days

Secondary outcomes

clinical pregnancy

A clinical pregnancy is diagnosed based on the presence of ultrasound confirmation of a gestational sac in the uterus.

Time frame

1-6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tang-Du Hospital

Lead sponsor

Xi'an Jiaotong University

Collaborator

Source ClinicalTrials.gov

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