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.

Conditions

• Thin Endometrial Lining
• Female Infertility
• Intrauterine Adhesions

Interventions

BIOLOGICAL

Mechanically Engineered Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes

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.

BIOLOGICAL

Umbilical cord mesenchymal stem cell-derived exosomes

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.

BIOLOGICAL

platelet-rich plasma

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.

Sponsors & Collaborators

• Xi'an Jiaotong University

  collaborator OTHER

• Tang-Du Hospital

  lead OTHER

Principal Investigators

• The Fourth Military Medical University · Air Force Military Medical University, China

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-21

Primary Completion

2025-06-12

Completion

2027-03-31

Countries

• China

Study Locations