Very Small Embryonic-like Stem Cells for Ovary

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Autologous Very Small Embryonic-like Stem Cells(VSELs) for Premature Ovarian Failure

Conditions
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Stem Cell Transplant Complications, Premature Ovarian Failure

Intervention / Treatment
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* Biological: very small embryonic-like stem cell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are diagnosed as premature ovarian failure by professional doctor. Those have clear abnormal sex hormone levels Exclusion Criteria: Unmarried woman Suffering from other serious gynecological diseases or gynecological tumors Blood disease patients, thrombocytopenia or dysfunction, hypofibrinemia or anticoagulant therapy, long-term use of aspirin

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VSEL Max<br>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 | Biological: very small embryonic-like stem cell<br>* 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<br>* Other names: VSEL;|
| Experimental: VSEL Medium<br>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 | Biological: very small embryonic-like stem cell<br>* 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<br>* Other names: VSEL;|
| Experimental: VSEL Mini<br>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 | Biological: very small embryonic-like stem cell<br>* 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<br>* Other names: VSEL;|
| No Intervention: Control<br>5 mL plate-rich plasma with no cells inside were injected into the bilateral fallopian tubes as a control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |