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Very Small Embryonic-like Stem Cells for Ovary

Phase 1
Withdrawn
Conditions
Stem Cell Transplant Complications
Premature Ovarian Failure
Registration Number
NCT03985462
Lead Sponsor
Fuda Cancer Hospital, Guangzhou
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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
Female
Target Recruitment
Not specified
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Concentration of Blood female hormones level1 month after injection

Check whether blood FSH, LH and E2 levels return to normal

Secondary Outcome Measures
NameTimeMethod
Incidence of amenorrhea12 months after injection

Inquire about menstrual condition and exam ovarian blood supply by gynecological color ultrasound

Concentration of Blood female hormones level12 months after injection

Check whether blood FSH, LH and E2 levels return to normal

Trial Locations

Locations (1)

Biological treatment center in Fuda cancer hospital

🇨🇳

Guangzhou, Guangdong, China

Biological treatment center in Fuda cancer hospital
🇨🇳Guangzhou, Guangdong, China

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