Premature Ovarian Failure, Stem Cell Transplant Complications
Conditions
Brief summary
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
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.
Interventions
BIOLOGICALvery small embryonic-like stem cell
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
Sponsors
Guangzhou Four-Leaf Clover HealthTech Co., Ltd.
Fuda Cancer Hospital, Guangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The number of patients enrolled and the number of injected cells were randomly selected by the investigator
Intervention 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
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Blood female hormones level | 1 month after injection | Check whether blood FSH, LH and E2 levels return to normal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Blood female hormones level | 6 months after injection | Check whether blood FSH, LH and E2 levels return to normal |
| Incidence of amenorrhea | 6 months after injection | Inquire about menstrual condition and exam ovarian blood supply by gynecological color ultrasound |
Countries
China
Outcome results
None listed