Clinical Study on the Safety and Efficacy of Human Amniotic Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorYan Hongli

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

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Yan Hongli

Lead sponsor

Changhai Hospital

Sponsor institution