Using engineered stem cell exosomes to treat thin endometrial lining in women
Evaluation of the Therapeutic Effects of Mechanically Engineered Umbilical Cord-Derived Stem Cell Exosomes on Endometrial Injury: A Prospective, Non-Randomized, Parallel-Controlled Clinical Study
This study tests if a new treatment using special stem cell particles can help women with a thin uterine lining get thicker linings compared to standard treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | Tang-Du Hospital Academic / other |
| Locations | 2 sites (Xi'an, Shaanxi and 1 other locations) |
| Trial ID | NCT06896747 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of mechanically engineered umbilical cord-derived stem cell exosomes compared to conventional exosomes and platelet-rich plasma (PRP) in improving endometrial thickness in women with thin endometrium due to intrauterine adhesions. Participants will receive one of the three treatments via subendometrial injection and will be monitored for changes in endometrial parameters and clinical pregnancy rates. The study aims to determine if the engineered exosomes provide superior therapeutic effects over the other treatments.
Who should consider this trial
Good fit: Ideal candidates are females aged 20-40 with a history of intrauterine adhesions and thin endometrium who are planning to continue assisted reproductive techniques.
Not a fit: Patients with severe systemic diseases, reproductive tract infections, or contraindications to the treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve endometrial thickness and increase pregnancy rates in women facing infertility due to thin endometrium.
How similar studies have performed: While exosome-based therapies are emerging, this specific approach of mechanically engineered exosomes for endometrial treatment is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Females aged 20-40 years (inclusive of boundary values); 2. Normal ovarian reserve function (criteria: AFC ≥ 7, AMH \> 1.1 ng/mL); 3. History of transcervical resection of adhesions (TCRA); 4. Received PRP treatment after TCRA; 5. At least one embryo transfer (ET) cycle in which they underwent standard ovarian stimulation (fresh cycle) or standard hormone replacement therapy (FET cycle), with an endometrial thickness of \<7 mm; 6. Planned to continue IVF/ICSI/FET-assisted conception; 7. Able to accept and adhere to treatment and follow-up and willing to sign an informed consent form. Exclusion Criteria: 1. Patients with severe systemic diseases, surgical contraindications, or cycle contraindications; 2. Patients with reproductive tract infections, genital tuberculosis, pelvic inflammatory disease, or malignant tumors of reproductive organs; 3. Patients with systemic diseases that cause uterine bleeding; 4. Patients allergic to any drugs, materials, or components used in this study; 5. Patients at high risk for hormone-dependent tumors such as breast cancer or ovarian tumors; 6. Patients with untreated submucosal fibroids of any size (FIGO 0/I/II), uterine fibroids ≥5 cm (FIGO III, IV, V, VI, VII), adenomyosis, unicornuate uterus, bicornuate uterus, or endometrial polyps; 7. Patients with hydrosalpinx ≥3 cm or hydrosalpinx of any size with significant vaginal discharge; 8. Patients with ovarian endometriotic cysts (chocolate cysts) ≥4 cm; 9. Patients who participated in other clinical trials within 3 months before surgery or during the study period; 10. Patients unable to tolerate anesthesia; 11. Patients with genetic abnormalities; 12. Other patients deemed unsuitable for participation in this study by the investigator.
Where this trial is running
Xi'an, Shaanxi and 1 other locations
- Tang-Du Hospital — Xi'an, Shaanxi, China (Recruiting)
- Tang-Du Hospital — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Principal investigator: The Fourth Military Medical University — Air Force Military Medical University, China
- Study coordinator: Wanlin Zhang, PhD
- Email: 1843678023@qq.com
- Phone: +86 18149363396
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.