A Randomized, Open-label, Parallel-controlled Clinical Study of Amniotic Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency

Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 40
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
China
Shanghai Changhai Hospital
RECRUITING
Shanghai
Contact Information
Primary
Hongli Yan PhD, Professor, Reproductive Medici
hongliyan@smmu.edu.cn
021-31162338
Time Frame
Start Date: 2024-10-15
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 50
Treatments
Active_comparator: Climen
Hormone replacement therapy (HRT): Take the drug Climen. Each box has 21 tablets. The first 11 tablets contain 2 milligrams of estradiol valerate each. The last 10 tablets contain 2 milligrams of estradiol valerate and 1 milligram of cyproterone acetate each. Begin taking it on the fifth day of your menstrual cycle. Take one tablet every day for seven days. Then, stop taking the medicine for seven days. After that, continue for two cycles in a row.
Experimental: hA-MSCs+Climen
The stem cell treatment group will be administered Climen, with the dosage and method of administration to be determined based on the control group. Concurrently, patients will receive the initial infusion of amniotic MSCs intravenously on the third day after the onset of menstruation, with a subsequent infusion administered after one month. The number of stem cells infused was calculated according to 1 million cells per kilogram of body weight.
Sponsors
Leads: Yan Hongli

This content was sourced from clinicaltrials.gov