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

NCT ID: NCT07115082

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2026-03-30

Brief 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.

Detailed Description

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.

Conditions

Premature Ovarian Insufficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Climen 21 Tablets

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Climen 21 Tablets

Intervention Type: DRUG

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.

hA-MSCs

Intervention Type: BIOLOGICAL

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.

Interventions

Climen 21 Tablets

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.

Intervention Type: DRUG

hA-MSCs

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yan Hongli

OTHER

Sponsor Role: lead

Responsible Party

Yan Hongli

Professor of Reproductive Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Shanghai Changhai Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongli Yan PhD, Professor, Reproductive Medici

Role: CONTACT

hongliyan@smmu.edu.cn

021-31162338

Other Identifiers

CHEC2023-172

Identifier Type: -

Identifier Source: org_study_id