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

RecruitingPhase 1, Phase 2Ages 20 Years - 40 YearsFemaleYan Hongli
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. The intention of pregnant women aged \>= 20 and \< 40, with normal karyotype; 2. Oligo/amenorrhea for at least 4 months; 3. Elevated FSH level \>25 IU/l on two occasions \>4 weeks apart; 4. Without a history of stem cell therapy and no growth hormone and/or estrogen and progesterone therapy within the previous 3 months; 5. Voluntary participation in the study with signed informed consent; Exclusion Criteria: 1. Unable to follow the treatment observation process required by the trial; 2. Genetic diseases, chromosomal abnormalities, and genetic deficiency that clearly cause premature ovarian insufficiency/premature ovarian failure; 3. With breast, uterine, ovarian tumors, or any other benign or malignant tumors; 4. Allergic history to drugs or any other things; 5. Presence of genetic disorders such as Turner's syndrome, congenital malformations of the reproductive organs. 6. Have undergone ovariectomy or have organic gynaecological diseases. 7. Presence of other gynaecological endocrine diseases such as polycystic ovary syndrome. 8. Severe functional impairment of vital organs. 9. High risk factors for venous thromboembolism and abnormalities in coagulation mechanisms. 10. Attending doctor considers inappropriate to take part in.
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What it tests

  • Climen 21 Tablets
  • hA-MSCs
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Where

1 site
Shanghai Changhai Hospital
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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