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

NCT ID: NCT03877471

Last Updated: 2021-08-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-03
• Study Completion Date: 2021-12-31

Brief 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.

Detailed 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).

Conditions

Primary Ovarian Insufficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low dosage

The low dosage will inject 2 million MSC-like cells (in 100ul suspension) for each ovary.

Group Type: EXPERIMENTAL

Cell therapy

Intervention Type: GENETIC

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

Medium dosage

The medium dosage will inject 5 million MSC-like cells (in 100ul suspension) for each ovary.

Group Type: EXPERIMENTAL

Cell therapy

Intervention Type: GENETIC

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

High dosage

The high dosage will inject 10 million MSC-like cells (in 100ul suspension) for each ovary.

Group Type: EXPERIMENTAL

Cell therapy

Intervention Type: GENETIC

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

Interventions

Cell therapy

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

Intervention Type: GENETIC

Eligibility Criteria

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.

• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

National Natural Science Foundation of China

OTHER_GOV

Sponsor Role: collaborator

Chinese Academy of Sciences

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hongmei Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hongmei Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Institute of Zoology, Chinese Academy of Sciences

Locations

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Countries

China

Other Identifiers

IOZ ChineseAS POI-2

Identifier Type: -

Identifier Source: org_study_id