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.
This clinical trial is designed to understand the safety and effectiveness of human amniotic membrane mesenchymal stem cells (hA-MSCs) in the treatment of primary ovarian insufficiency (POI). Human amniotic MSCs were infused back into the patients by intravenous injection. The trial was designed with two groups, 1) the control group by conventional hormone replacement therapy with oral Climen and 2) the stem cell treatment group by intravenous infusion of human amniotic membrane mesenchymal stem cells (hA-MSCs) combined with oral Climen hormone therapy. Patients were followed up every 2 weeks after the post-injection stem cells to observe their outcomes. The investigators focused on safety indicators, but also monitored hormone levels and signs of follicular growth to initially assess the effectiveness of the stem cells.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
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.
Shanghai Changhai Hospital
Shanghai, China
RECRUITINGTemperature
Body temperature of the participants will be measured fortnightly after injection.
Time frame: Up to 24 weeks
Pulse
Pulse of the participants will be measured fortnightly after injection.
Time frame: up to 24 weeks
Breaths per minute
Breathing rate of the participants will be measured fortnightly after injection.
Time frame: up to 24 weeks
Blood pressure
Both systolic pressure and diastolic pressure of the participants will be assessed fortnightly after injection.
Time frame: 0-24 weeks
Follicle-stimulating hormone (FSH) serum level
Serum FSH level will be tested fortnightly after injection.
Time frame: Up to 24 weeks
Estradiol (E2) serum level
Serum E2 level will be tested fortnightly after injection.
Time frame: Up to 24 weeks
Anti-Mullerian hormone (AMH) serum level
Serum AMH level will be tested fortnightly after injection.
Time frame: up to 24 weeks
Number of antral follicle
The number of antral follicles developing will be recorded by transvaginal ultrasound fortnightly after injection.
Time frame: up to 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Achievement of pregnancy
A transvaginal ultrasound confirmation of gestational sac The hCG levels have reached between 1,000 - 2,000 mIU/mL.
Time frame: up to 12 months