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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03877471
Other study ID # IOZ ChineseAS POI-2
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date April 3, 2019
Est. completion date December 31, 2021

Study information

Verified date August 2021
Source Chinese Academy of Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). So far, there was no treatment sufficient enough to cure POI. Cell therapy is a rapidly developing field and have shown immense promise in the treatment of ovarian dysfunction. In this study, the investigator will evaluate the safety of MSC-like cell therapy in women suffering from POI.


Description:

The purpose of this work is to explore the safety and preliminary efficacy of human embryonic stem cell derived MSC-like cell transplantation in women with POI. MSC-like cells were injected directly into bilateral ovaries under transvaginal ultrasound. Patients are subjected into 3 groups, with low (0.2×107), medium (0.5×107) and high dosage (1.0×107) of cells injection for each ovary. The outcomes of patients were followed after the injection every 2 weeks. The investigator mainly follow the safety indexes, and the level of sex hormone and signs of follicle growth will also be monitored. The growing follicles will be stimulated by exogenous hormone, followed by oocyte retrieval and in vitro fertilization (IVF).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 28
Est. completion date December 31, 2021
Est. primary completion date July 1, 2020
Accepts healthy volunteers No
Gender Female
Age group N/A to 40 Years
Eligibility Inclusion Criteria: 1. Under 40 years of age; 2. Have established regular menstrual cycle, oligomenorrhea / amenorrhea = 4 months; 3. FSH (Follicle-Stimulating Hormone) > 25 IU/mL; 4. Bilateral ovaries are visible by ultrasound; 5. Have fertility requirement, husband has sperms; 6. Willing to sign the Informed Consent Form. Exclusion Criteria: 1. Primary amenorrhea; 2. History of serious drug allergy or allergic constitution; 3. Thrombophlebitis and thromboembolia, 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.

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
Cell therapy
Ovary injection with MSC-like cells through transvaginal ultrasound,3 injection points for each ovary.

Locations

Country Name City State
China The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan

Sponsors (3)

Lead Sponsor Collaborator
Chinese Academy of Sciences National Natural Science Foundation of China, The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Temperature Body temperature of the participants will be measured fortnightly after injection. 0-24 weeks
Primary Pulse Pulse of the participants will be measured fortnightly after injection. 0-24 weeks
Primary Breaths per minute Breathing rate of the participants will be measured fortnightly after injection. 0-24 weeks
Primary Blood pressure Both systolic pressure and diastolic pressure of the participants will be assessed fortnightly after injection. 0-24 weeks
Secondary Number of antral follicle The number of antral follicles developing will be recorded by transvaginal ultrasound fortnightly after injection. 0-24 weeks
Secondary Follicle-stimulating hormone (FSH) serum level Serum FSH level will be tested fortnightly after injection. 0-24 weeks
Secondary Estradiol (E2) serum level Serum E2 level will be tested fortnightly after injection. 0-24 weeks
Secondary Anti-Mullerian hormone (AMH) serum level Serum AMH level will be tested fortnightly after injection. 0-24 weeks
Secondary Ovarian volume The ovarian volume will be recorded fortnightly by transvaginal ultrasound after injection. 0-24 weeks
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