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| Name | Class |
|---|---|
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| National Natural Science Foundation of China | OTHER_GOV |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dosage | Experimental | The low dosage will inject 2 million MSC-like cells (in 100ul suspension) for each ovary. |
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| Medium dosage | Experimental | The medium dosage will inject 5 million MSC-like cells (in 100ul suspension) for each ovary. |
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| High dosage | Experimental | The high dosage will inject 10 million MSC-like cells (in 100ul suspension) for each ovary. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cell therapy | Genetic | Ovary injection with MSC-like cells through transvaginal ultrasound,3 injection points for each ovary. |
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| Measure | Description | Time Frame |
|---|---|---|
| Temperature | Body temperature of the participants will be measured fortnightly after injection. | 0-24 weeks |
| Pulse | Pulse of the participants will be measured fortnightly after injection. | 0-24 weeks |
| Breaths per minute | Breathing rate of the participants will be measured fortnightly after injection. | 0-24 weeks |
| Blood pressure | Both systolic pressure and diastolic pressure of the participants will be assessed fortnightly after injection. | 0-24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of antral follicle | The number of antral follicles developing will be recorded by transvaginal ultrasound fortnightly after injection. | 0-24 weeks |
| Follicle-stimulating hormone (FSH) serum level |
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Inclusion Criteria:
Exclusion Criteria:
Only female will be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Hongmei Wang, Doctor | Institute of Zoology, Chinese Academy of Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
The investigator have not recruited enough participant yet, till now, most of them would like to keep the individual participant data classified.
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| ID | Term |
|---|---|
| D016649 | Primary Ovarian Insufficiency |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D064987 | Cell- and Tissue-Based Therapy |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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Patients will be subjected into 3 groups, with a low (0.2×107), medium (0.5×107) and high dosage (1.0×107) of cells transplantation for each ovary. The investigator will first carry out the low dosage group, and then the medium dosage group, based on the safety evaluation of the previous group, the high dosage group will be executed in the same way.
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Serum FSH level will be tested fortnightly after injection.
| 0-24 weeks |
| Estradiol (E2) serum level | Serum E2 level will be tested fortnightly after injection. | 0-24 weeks |
| Anti-Mullerian hormone (AMH) serum level | Serum AMH level will be tested fortnightly after injection. | 0-24 weeks |
| Ovarian volume | The ovarian volume will be recorded fortnightly by transvaginal ultrasound after injection. | 0-24 weeks |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |