Mesenchymal Stem Cells (MSCs) - Like Cell Transplantation in Women With Primary Ovarian Insufficiency

Primary Ovarian Insufficiency Clinical Trial

— MSCLCTWPOI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03877471
• Other study ID #: IOZ ChineseAS POI-2
• Status: Active, not recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Menopause, Premature
• Primary Ovarian Insufficiency

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