About this trial
There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). So far, there was no treatment sufficient enough to cure POI. Cell therapy is a rapidly developing field and have shown immense promise in the treatment of ovarian dysfunction. In this study, the investigator will evaluate the safety of human Amniotic mesenchymal stem cells (hA-MSCs) therapy in women suffering from POI.
Eligibility criteria
Qualifiers
The intention of pregnant women aged >= 20 and < 40, with normal karyotype;
Oligo/amenorrhea for at least 4 months;
Elevated FSH level >25 IU/l on two occasions >4 weeks apart;
Without a history of stem cell therapy and no growth hormone and/or estrogen and progesterone therapy within the previous 3 months;
Disqualifiers
Unable to follow the treatment observation process required by the trial;
Genetic diseases, chromosomal abnormalities, and genetic deficiency that clearly cause premature ovarian insufficiency/premature ovarian failure;
With breast, uterine, ovarian tumors, or any other benign or malignant tumors;
Allergic history to drugs or any other things;
Trial design
Treatments tested in this trial
- Climen 21 Tablets
- hA-MSCs
Treatment groups
Sponsors and collaborators
Yan Hongli
Lead sponsor
Changhai Hospital
Sponsor institution