Fat-derived cell treatment for thin uterine lining and intrauterine adhesions

Autologous Adipose-derived Stromal Vascular Fraction Therapy for Refractory Endometrial Infertility

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
• Enrollment: 10 (estimated)
• Ages: 22 Years to 45 Years
• Sex: Female
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07230600 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Nanjing, Jiangsu

• 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

Conditions Endometrium; Atrophy; Intrauterine Synechiae; adipose-derived stromal vascular fraction; thin endometrium