Clinical Study on the Safety and Efficacy of Human Amniotic Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency
A Randomized, Open-label, Parallel-controlled Clinical Study of Amniotic Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency
Yan Hongli
50 participants
Oct 15, 2024
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria5
- 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;
- Voluntary participation in the study with signed informed consent;
Exclusion Criteria10
- 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;
- Presence of genetic disorders such as Turner's syndrome, congenital malformations of the reproductive organs.
- Have undergone ovariectomy or have organic gynaecological diseases.
- Presence of other gynaecological endocrine diseases such as polycystic ovary syndrome.
- Severe functional impairment of vital organs.
- High risk factors for venous thromboembolism and abnormalities in coagulation mechanisms.
- Attending doctor considers inappropriate to take part in.
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Interventions
Climen is commonly used clinically as a hormone replacement therapy and was administered to all patients in both the control and experimental groups in this project.
The patients who were part of the experimental group were administered oral Clomid medication in conjunction with a combined intravenous injection of human amniotic MSCs.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07115082