Fat-derived cell treatment for thin uterine lining and intrauterine adhesions
Official title: Autologous Adipose-derived Stromal Vascular Fraction Therapy for Refractory Endometrial Infertility
Run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · NCT07230600 · Data updated 2026-11-12
This trial will try using a patient's own fat-derived stromal vascular fraction infused into the uterus to see if it thickens the endometrium and helps women with very thin linings or moderate to severe intrauterine adhesions become more fertile.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 22 Years to 45 Years |
| Sex | Women only |
| Enrollment | 10 (estimated) |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | November 2025 |
| Main results expected | December 2026 |
| Study ends | June 2027 |
| Registry record updated | November 18, 2025 |
| Trial ID | NCT07230600 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women seeking pregnancy with refractory thin endometrium (<6 mm) and/or moderate to severe intrauterine adhesions, who have normal ovarian function or cryopreserved embryos and a BMI between 18 and 30, are the intended participants.
✕Probably not a fit
Patients with partner chromosomal abnormalities, severe endometriosis, fibroids or uterine malformations that distort the cavity, significant organ dysfunction, coagulation disorders, or uncontrolled systemic disease are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 interventional trial enrolls women with refractory thin endometrium (<6 mm) or moderate to severe intrauterine adhesions who desire pregnancy. Participants undergo liposuction to obtain adipose tissue, from which adipose-derived stromal vascular fraction (AD-SVF) is isolated and infused into the uterine cavity. Patients are followed for six months to record changes in menstrual volume, endometrial thickness, and any early pregnancy outcomes, with repeat hysteroscopy if clinically indicated. The single-center trial at the Affiliated Nanjing Drum Tower Hospital focuses on initial safety and early signals of efficacy.
Why it matters
Potential benefit: If successful, this treatment could restore endometrial thickness and improve chances of conception for women with refractory thin endometrium or intrauterine adhesions.
How similar studies have gone: Early case reports and small series using bone marrow or adipose-derived stem cell approaches have shown promising results, but intrauterine AD-SVF remains experimental with limited high-quality evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. refractory thin endometrium (endometrial thickness \< 6 mm on the day of ovulation or the day of endometrial transformation during a hormone replacement cycle) and/or moderate to severe intrauterine adhesion; 2. Inability to undergo autologous bone marrow stem cells-scaffold (BMSC) transplantation due to failed bone marrow aspiration, or lack of significant effect following the BMSC treatment; 3. with fertility intentions; 4. normal ovarian function or availability of cryopreserved embryos; 5. 18kg/m\^2 \< body mass index (BMI) \< 30kg/m\^2; Exclusion Criteria: 1. Chromosomal karyotype abnormalities in one spouse; 2. Severe endometriosis, uterine fibroids affecting the uterine cavity morphology, or uterine malformations; 3. Abnormalities in coagulation function, hepatic or renal function, or other underlying conditions deemed by the investigator to potentially impact the study's progression (uncontrolled hypertension, diabetes, autoimmune diseases, etc.); 4. Contraindications for pregnancy; 5. Contraindications for hormonal cycle therapy; 6. History of pelvic tumors; 7. Simultaneous participation in other clinical studies.
Where it's running
-
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China Recruiting
Study contacts
- Principal investigator: Yali Hu — The Affiliated Drum Tower Hospital of Nanjing University
- Study coordinator: Yali Hu
- Email: glyyhuyali@163.com
- Phone: 86-025-83106666
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.