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Clinical study on the safety and efficacy of human umbilical cord mesenchymal stem cells in the treatment of premature ovarian insufficiency

Clinical study on the safety and efficacy of human umbilical cord mesenchymal stem cells in the treatment of premature ovarian insufficiency

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073345
Enrollment
Unknown
Registered
2023-07-07
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-07-10

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

Conditions

Premature ovarian insufficiency

Interventions

Low dose group:Intravenous infusion of 5E7 human umbilical cord mesenchymal stem cells
medium dose group:Intravenous infusion of 1E8 human umbilical cord mesenchymal stem cells
high dose group:Intravenous infusion of 2E8 human umbilical cord mesenchymal stem cells

Sponsors

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technolog
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Women aged 18 to 40 (including 18 years old but excluding 40 years old) 2. Women who meet the diagnosis of premature ovarian insufficiency 3. Sign the informed consent form voluntarily.

Exclusion criteria

Exclusion criteria: 1. Patients with secondary ovarian insufficiency (the following thalamic reasons) 2. Previous history of malignant tumor or ovarian tumor, or current malignant tumor 3. Polycystic ovary syndrome, hyperprolactinemia, hyperandrogenism, diabetes, thyroid and adrenal dysfunction and other endocrine diseases affecting ovarian function 4. HIV positive, hepatitis virus positive 5. Abnormal liver function 6. Abnormal renal function 7. Patients with allergic constitution and allergic to human serum albumin 8. Acute or chronic infection, blood disease, cardiovascular disease, lung disease, liver disease, kidney disease, pancreatic disease 9. Those who are taking hormone drugs (less than 3 months after drug withdrawal) and are willing to receive hormone supplement treatment in the near future 10. Participate in other clinical studies or other clinical studies within 3 months 11. Pregnant or lactating women or those who have a pregnancy plan within 6 months 12. Patients with drug abuse, methadone treatment, drug dependence or mental illness 13. Those who have received blood transfusion and other blood products treatment within 3 months 14. The attending doctor believes that patients are not suitable for this study.

Design outcomes

Primary

MeasureTime frame
sex hormone;MRS;Ultrasound of uterine appendages;AMH;

Secondary

MeasureTime frame
Leucorrhea routine;Evaluation of pelvic floor muscle function;BGP+VitD;MoCA;PSQI;Immunological flow monitoring;DASS-21;VHIS+FSFI;thyroid function;glycosylated hemoglobin;gynecological examination; Bone mineral density test;

Countries

China

Contacts

Public ContactWang Shixuan

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technolog

sxwang@tjh.tjmu.edu.cn+86 27 8366 3698

Outcome results

None listed

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