1、Study Objectives
1. Primary Objective To evaluate the clinical safety of human iPSC-derived exosome liquid dressing (GD007) in patients with moderate-to-severe intrauterine adhesions (IUA).
2. Secondary Objectives To assess the IUA recurrence rate within 6 months post-treatment. To investigate endometrial thickness improvement as a marker of endometrial regeneration.
2、Study Design: Single-center, prospective, open-label 3、Study Procedures IUA Treatment Protocol Patients diagnosed with moderate-to-severe intrauterine adhesions (IUA) will undergo standard hysteroscopic adhesiolysis.
Eligible patients who provide informed consent will receive:
* First exosome perfusion: 24 hours post-operatively
* Subsequent perfusions: Every 3 days (total 3 perfusions)
Follow-up hysteroscopy at 1 month to assess adhesion recurrence:
If adhesions recur: Repeat adhesiolysis (Step 1) followed by another 3-perfusion cycle (24h post-op)
Monthly follow-up for 6 months to monitor:
* Adverse events (per CTCAE v5.0)
* Endometrial thickness (transvaginal ultrasound) Fertility Management IVF/ICSI:Embryo transfer performed per standard protocols after completing exosome therapy Endometrial preparation and transfer procedures follow institutional SOPs Natural conception:Ultrasound-guided ovulation monitoring + timed intercourse Detailed documentation of clinical pregnancy outcomes 4、 Patient Selection Criteria Inclusion Criteria 1) Demographics
* Females aged 20-40 years with fertility desire 2) Diagnostic Confirmation
* Hysteroscopically confirmed moderate-to-severe intrauterine adhesions (IUA) \*(Per 2015 Chinese IUA Scoring System: Moderate=9-18 points; Severe=19-28 points)\* 3) Surgical Eligibility
* Indicated for hysteroscopic surgery without contraindications 4) Ovarian Function
* Normal ovarian reserve (AMH ≥1.1 ng/mL or AFC ≥5) 5) Consent
* Voluntary participation with signed informed consent Exclusion Criteria
1\. Active Infections
* Acute pelvic inflammatory disease or vaginitis 2. Uterine Abnormalities
* History of uterine artery embolization
* Submucosal fibroids (\>2 cm)
* Adenomyosis with uterine size \>8-week gestation 3. Neoplastic Conditions
* Malignancies
* Endometrial hyperplasia (with/without atypia) 4. Contraindications
* Hypersensitivity to hyaluronic acid gel 5. Hormonal Medications
* Chronic steroid use
* High-dose hormone therapy (\>8 mg/day estrogen/progestin within 1 month) 6. Hematologic Disorders
* Thrombocytopenia (platelets \<50×10⁹/L)
* Coagulopathy (aPTT \>1.5×ULN) 7. Systemic Diseases
* Uncontrolled diabetes (HbA1c \>7%)
* Severe cardiovascular disease (NYHA Class III/IV)
* Life-threatening comorbidities 8. Clinical Trial Participation
* Enrollment in other interventional trials within 3 months
* Recent drug trials (\<5 half-lives from last dose) 9. Investigator's Discretion
* Any condition deemed unsuitable for participation
