NCT03985462WithdrawnPhase 1
Autologous Very Small Embryonic-like Stem Cells(VSELs) for Premature Ovarian Failure
Fuda Cancer Hospital, Guangzhou1 site in 1 countryStarted: July 3, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Concentration of Blood female hormones level
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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
Eligibility Criteria
- Ages
- 30 Years to 40 Years (Adult)
- Sex
- Female
- Accepts 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
Outcomes
Primary Outcomes
Concentration of Blood female hormones level
Time Frame: 1 month after injection
Check whether blood FSH, LH and E2 levels return to normal
Secondary Outcomes
- Incidence of amenorrhea(12 months after injection)
- Concentration of Blood female hormones level(12 months after injection)
Investigators
Study Sites (1)
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