Clinical Study on the Effect of Umbilical Cord Mesenchymal Stem Cell Exosomes on Endometrial Repair of Intrauterine Adhesions

Intrauterine adhesions (IUA) is a group of diseases caused by endometrial injury leading to occlusion of the uterine cavity and serious abnormality of the uterine cavity morphology, which causes primary or secondary infertility by affecting embryo implantation. At present, the poor effectiveness of clinical treatment methods has made the thin endometrium after intrauterine adhesions an urgent problem to be solved in the clinical field of assisted reproduction.

Stem cells with multi-directional differentiation potential provide a new idea for the treatment of cervical adhesions. However, due to limitations such as stem cell extraction, technical conditions, and ethical issues, clinical application cannot be widely carried out. Exosomes are vesicle structures produced by paracrine secretion of cells, containing abundant proteins, RNA, etc., and mediating information exchange between cells. Recent studies have found that stem cells play a role in tissue repair mainly through paracrine, and stem cell-derived exosomes have similar functions to stem cells. Human cord mesenchymal stem cells were selected as an intervention for this clinical study because of their wide source, easy access, and low immunogenicity.

Therefore, in this clinical study, the investigator will evaluate the clinical safety and efficacy of infusing human umbilical cord mesenchymal stem cell exosomes into the uterine cavity for the treatment of thin endometrium after intrauterine adhesions.

Study Overview

• Status: Active, not recruiting
• Conditions: Intrauterine Adhesions; Exosomes
• Intervention / Treatment: Drug: HRT; Combination product: Exosmoes

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510600
      • No. 26, Second Horizontal Road, Yan Village, Tianhe District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• (1) The subjects were able to fully understand the purpose of the screening and the trial, had sufficient understanding and compliance with the research protocol, and signed the informed consent form; (2) The subjects were aged between 20 and 38 years old; (3) The body mass index was 18-27 kg/m2; (4) The menstrual cycle was regular for at least half a year, with a duration of 27-35 days; (5) The ovarian reserve was normal, with at least 6 follicles (AFC), and the serum follicle-stimulating hormone (FSH) level on the 2nd-4th day of the menstrual cycle was between 1-10 IU/L, and other basic hormone indicators were within the normal range of clinical laboratories; (6) The serum human immunodeficiency virus (HIV) antibody, Treponema pallidum particle agglutination test (TPPA), hepatitis B surface antigen (HBsAg), and hepatitis C virus antibody (HCV-Ag) tests were negative within half a year; (7) Previous hysteroscopy diagnosis was moderate to severe intrauterine adhesions (AFS > 5 points); (8) There was a history of canceling frozen embryo transfer due to repeated B-ultrasound monitoring of thin endometrium and poor endometrial response (HRT cycle or/and late proliferative endometrium thickness < 6mm).

Exclusion Criteria:

• (1) Those who cannot accept the treatment and observation process as required by the trial; (2) Those with contraindications for hysteroscopic surgery; (3) Congenital uterine malformations; (4) Severe adenomyosis; (5) Uterine fibroids that may affect embryo implantation; (6) Other uterine factors judged by the researchers to be unsuitable for embryo implantation; (7) Patients with chromosomal abnormalities; (8) Patients with reproductive system tuberculosis, or those with immune system diseases (such as rheumatoid arthritis, systemic lupus erythematosus, etc.); (9) Chronic wasting or bleeding disorders; (10) Unaddressed tubal hydrosalpinx; (11) Contraindications for estrogen therapy; (12) Patients with systemic diseases， such as thrombosis， heart and lung diseases， hematological system diseases and malignant tumors， etc.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: The conventional treatment group; traditional hormone replacement therapy	Drug: HRT; After hysteroscopy, traditional hormone replacement therapy (HRT) cycle drug treatment was performed (from the day of the surgery to the 25th day of the menstrual cycle, 3 mg of estradiol valerate (Climen) was taken twice a day, and on the 16th day of the menstrual cycle, 10 mg of dydrogesterone (Duphaston) was added twice a day for 10 days).
Experimental: Exosomes group; Exosomes group：After hysteroscopic surgery, exosomes were infused into the uterus immediately, and traditional hormone replacement therapy (HRT) was given after surgery.	Drug: HRT; After hysteroscopy, traditional hormone replacement therapy (HRT) cycle drug treatment was performed (from the day of the surgery to the 25th day of the menstrual cycle, 3 mg of estradiol valerate (Climen) was taken twice a day, and on the 16th day of the menstrual cycle, 10 mg of dydrogesterone (Duphaston) was added twice a day for 10 days).; Combination product: Exosmoes; After hysteroscopy, immediate intracavitary perfusion therapy with exosomes was administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endometrial thickness	The thickness of the endometrium was measured through three-dimensional color ultrasound examination of the uterus. The thickness (in millimeters) of the endometrium before and after the hysteroscopy procedure was recorded.	One month after hysteroscopy surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical pregnancy rate	By conducting regular postoperative follow-ups on the participants, the investigator can observe their pregnancy outcomes and record whether they have successfully achieved clinical pregnancy.	1-1.5year
Live birth rate	By conducting regular postoperative follow-ups on the participates, the investigator can observe their pregnancy outcomes and record whether they have successfully achieved clinical pregnancy.	1-1.5year

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Gynatresia
• Other Study ID Numbers: 2023ZSLYFEC-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No