Skip to content

A single, non-randomized, open clinical study of collagen scaffolds containing human umbilical cord mesenchymal stem cells for the treatment of Asherman syndrome

A single, non-randomized, open clinical study of collagen scaffolds containing human umbilical cord mesenchymal stem cells for the treatment of Asherman syndrome

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031243
Enrollment
Unknown
Registered
2020-03-25
Start date
2020-05-01
Completion date
Unknown
Last updated
2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asherman Syndrome

Interventions

Group 1:Single implantation of collagen scaffolds containing human umbilical cord mesenchymal stem cells
Group 2:Collagen scaffold containing human umbilical cord mesenchymal stem cells implanted every 4 weeks for 8 consecutive weeks

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Women aged 20 to 40; 2. Have a history of induced abortion; 3. Patients with endometrial thickness less than 5.5mm by transvaginal ultrasonography (TVS)(all reports of intermediate luteal within 3 months were considered effective); 4. Patients who are not effective in 3 cycles after estrogen treatment; 5. Hysteroscopy AFS score 1 or above; 6. Patients with clear birth requirements; 7. Patients who understand and are willing to sign the written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with abnormal sexual hormone level (the level of serum testosterone in the 2nd-3rd day of menstrual cycle is higher than 0.75ug/ml, or the level of estrogen is lower than 20pg / ml); 2. Patients with thin endometrium and no intrauterine adhesions; 3. Patients with contraindications to hysteroscopy; 4. Patients with other uterine diseases such as hysteromyoma, serious adenomyosis and uterine malformation; 5. Patients with abnormal karyotype; 6. Patients with abnormal semen test results of spouse; 7. Pregnant or lactating women; 8. Patients with serious primary diseases and psychosis such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system; 9. Patients with reproductive tract infection (patients with reproductive tract infection can be included in the group according to the judgment of researchers after effective treatment and recovery); 10. LVEF < 50%; 11. Patients with abnormal liver and kidney function (GPT, GTT beyond the reference range, creatinine beyond the reference range); 12. Patients with malignant tumors; 13. Patients with other serious infectious diseases; 14. HBV, HCV or HIV or tuberculosis test positive at the time of patient screening 15. Patients who participated in other clinical trials (or used research drugs) within 3 months before enrollment; 16. Patients who have received stem cell transfusion and / or immunotherapy; 17. Patients who are unable to accept or cooperate with the study plan; 18. Patients judged by other researchers as unsuitable for inclusion in the trial.

Design outcomes

Primary

MeasureTime frame
Endometrial thickness;Menstruation;AFS;Pregnancy rate;

Countries

China

Contacts

Public ContactYinyan He

Shanghai General Hospital

yinyan.he@shgh.cn+86 18939761117

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026