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MSC-like cell therapy for primary ovarian insufficiency

Study for Safety of Human Embryonic Stem Cell Derived Mesenchymal Stem Cell (MSC)-Like Cells Transplantation in the treatment of Women With Primary Ovarian Insufficiency (POI)

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021921
Enrollment
Unknown
Registered
2019-03-16
Start date
2019-04-01
Completion date
Unknown
Last updated
2019-03-18

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

Conditions

Primary ovarian insufficiency

Interventions

Low dasage:Ovarian injection
Medium dasage: Ovarian injection
High dosage:Ovarian injection

Sponsors

Institute of Zoology, Chinese Academy of Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Under 40 years of age; 2. Have established regular menstrual cycle, oligomenorrhea / amenorrhea = 4 months; 3. Follicle-Stimulating Hormone(FSH)> 25U/L; 4. Bilateral ovaries are visible by ultrasound; 5. Have fertility requirement, husband has sperms; 6. Willing to sign the Informed Consent Form.

Exclusion criteria

Exclusion criteria: 1. Primary amenorrhea; 2. History of serious drug allergy or allergic constitution; 3. Thrombophlebitis and thrombembolia, past and present; 4. Acute or chronic infection, hematologic disease, angiocardiopathy, pulmonary disease, liver disease, nephropathy, pancreas disease 5. Autoimmune disease, history of severe familial genetic disease, etc. 6. Anatomical abnormality of reproductive system; 7. Contraindications for pregnancy; 8. Spouse azoospermia; 9. HIV+, hepatitis B, C; 10. Thyroid dysfunction; 11. History of previous malignant or ovarian tumors, history of ovarian therapy; 12. Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome); 13. During pregnancy or lactation; 14. Alcohol or other substance abuse; 15. Mental disease, communicate obstruction; 16. Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period; 17. Attending doctor consider inappropriate to take part in.

Design outcomes

Primary

MeasureTime frame
Vital signs;Adverse events;

Secondary

MeasureTime frame
Number of antral follicle;Sex hormones;Ovarian volume;

Countries

China

Contacts

Public ContactHongmei Wang

Institute of Zoology, Chinese Academy of Sciences

wanghm@ioz.ac.cn+86 010-64807187

Outcome results

None listed

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