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Policy changes have contributed to the failure to carry out smoothly
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| Name | Class |
|---|---|
| Guangzhou Four-Leaf Clover HealthTech Co., Ltd. | INDUSTRY |
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The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to premature ovarian failure.
Premature ovarian failure is diagnosed by blood femal hormones test of follicle stimulating hormone (FSH, > 40 IU/L)、luteinizing hormon (LH, > 40 IU/L)、estradiol (E2, > 100pg/mL) and/or amenorrhea before the age of 40. VSELs come from the patient's periperal blood, and will be injected in bilateral oviducts, followed-up by hormone testing and menstrual conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VSEL Max | Experimental | A total of 300,000 VSEL cells in 5 mL plate-rich plasma are injected into the bilateral fallopian tubes as a high dose group |
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| VSEL Medium | Experimental | A total of 200,000 VSEL cells in 5 mL plate-rich plasma are injected into the bilateral fallopian tubes as a middle dose group |
|
| VSEL Mini | Experimental | A total of 100,000 VSEL cells in 5 mL plate-rich plasma are injected into the bilateral fallopian tubes as a low dose group |
|
| Control | No Intervention | 5 mL plate-rich plasma with no cells inside were injected into the bilateral fallopian tubes as a control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| very small embryonic-like stem cell | Biological | Mononuclear cells were collected from peripheral blood of each patient using a machine, VSELs were isolated, and each group was injected according to different numbers after activation |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Blood female hormones level | Check whether blood FSH, LH and E2 levels return to normal | 1 month after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Blood female hormones level | Check whether blood FSH, LH and E2 levels return to normal | 6 months after injection |
| Incidence of amenorrhea | Inquire about menstrual condition and exam ovarian blood supply by gynecological color ultrasound |
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Inclusion Criteria:
Exclusion Criteria:
Only female patients are enrolled in this research
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biological treatment center in Fuda cancer hospital | Guangzhou | Guangdong | 510000 | China |
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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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Patients with confirmed premature ovarian failure were divided into three groups, each group was injected with different numbers of VSEL cells, and the control group was injected with platelet-rich serum which is the cell solvent
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The number of patients enrolled and the number of injected cells were randomly selected by the investigator
|
| 6 months after injection |
| Concentration of Blood female hormones level | Check whether blood FSH, LH and E2 levels return to normal | 12 months after injection |
| Incidence of amenorrhea | Inquire about menstrual condition and exam ovarian blood supply by gynecological color ultrasound | 12 months after injection |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |