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

NCT07115082 | Recruiting Phase 1

• 1 other identifier: CHEC2023-172
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Ovarian Insufficiency

Keywords

hA-MSCs; Premature ovarian insufficiency

Outcome Measures

Primary Outcomes (4)

• Temperature

  Body temperature of the participants will be measured fortnightly after injection.

  Up to 24 weeks

• Pulse

  Pulse of the participants will be measured fortnightly after injection.

  up to 24 weeks

• Breaths per minute

  Breathing rate of the participants will be measured fortnightly after injection.

  up to 24 weeks

• Blood pressure

  Both systolic pressure and diastolic pressure of the participants will be assessed fortnightly after injection.

  0-24 weeks

Secondary Outcomes (5)

• Follicle-stimulating hormone (FSH) serum level

  Up to 24 weeks

• Estradiol (E2) serum level

  Up to 24 weeks

• Anti-Mullerian hormone (AMH) serum level

  up to 24 weeks

• Number of antral follicle

  up to 24 weeks

• Achievement of pregnancy

  up to 12 months

Study Arms (2)

Climen

ACTIVE COMPARATOR

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.

Drug: Climen 21 Tablets

hA-MSCs+Climen

EXPERIMENTAL

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.

Drug: Climen 21 Tablets; Biological: hA-MSCs

Interventions

Climen 21 Tablets 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.

Climen; hA-MSCs+Climen

hA-MSCs 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.

hA-MSCs+Climen

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yan Hongli: lead

Study Sites (1)

Shanghai Changhai Hospital

Shanghai, 200433, China

RECRUITING

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Central Study Contacts

Hongli Yan PhD, Professor, Reproductive Medici

CONTACT

021-31162338; hongliyan@smmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Reproductive Medicine

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: August 11, 2025
• Study Start: October 15, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 30, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

CN (1)