Intravenous hUC-MSCs for POI: Safety, Tolerability and Early Efficacy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase Ⅰ/Ⅱa study assesses the safety and tolerability of IV hUC-MSCs in POI patients and aims to identify a dose for the next phase. It also explores preliminary efficacy to support further confirmatory trials. The trial uses a dose-escalation Phase I period followed by a dose-expansion Phase IIa period, with placebo control as part of the design. Eligible participants are women aged 18–40 who have POI with specific hormonal and ovarian reserve criteria and who are on stable hormone replacement therapy. Primary endpoints in Phase I focus on safety, while Phase IIa emphasizes efficacy signals and data for future pivotal trials.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18 to 40 years at the time of signing the informed consent form (exclusive of the boundary values);
2. Meet the diagnostic criteria specified in the Expert Consensus on Clinical Diagnosis and Treatment of Premature Ovarian Insufficiency (2023 Edition): oligomenorrhea (menstrual cycle longer than 35 days) or amenorrhea for more than 4 months, with basal serum follicle-stimulating hormone (FSH) \> 25 U/L (tested on Days 2-4 of the menstrual cycle or during amenorrhea, at least twice with an interval of ≥4 weeks);
3. Satisfy one of the following two criteria:

   1. Total number of antral follicles (AFC) with a diameter of 2-10 mm in bilateral ovaries \< 5;
   2. Serum anti-Müllerian hormone (AMH) ≤ 7.85 pmol/L (equivalent to 1.1 ng/mL);
4. Have received standardized hormone replacement therapy (HRT) at a stable dose for ≥3 months prior to drug administration with stable hormone levels, and maintain stable HRT per medical advice throughout the trial (within 24 weeks after enrollment);
5. Have no fertility requirements;
6. Agree to use effective contraceptive measures throughout the trial period (such as complete abstinence, condoms, cervical caps plus spermicides, intrauterine devices, etc.);
7. Negative serum β-hCG test result during the screening period (to rule out pregnancy);
8. Fully understand the trial information and sign the informed consent form.

Exclusion Criteria:

1. Subjects with primary amenorrhea;
2. Subjects with thyroid disorders (hypothyroidism/hyperthyroidism or thyroid malignant tumors) or resistant ovary syndrome (ROS);
3. Subjects with abnormal female karyotypes (e.g., Turner syndrome, Fragile X syndrome);
4. Positive serology tests (HBV antibody, HCV antibody, HIV antibody, syphilis). Exceptions: HBV carriers, patients with stable HBV after drug treatment (HBV DNA titer ≤500 IU/mL or copies \<1000 copies/mL), and patients with cured HCV (negative HCV RNA test) may be enrolled if deemed eligible by the investigator;
5. Subjects receiving or planning to use the following medications during the trial: oral or systemic corticosteroids, danazol, anticoagulants, Chinese herbal medicines or botanical supplements that may affect hormone levels or ovarian function;
6. History of hypersensitivity to human serum albumin;
7. Pregnant or breastfeeding subjects;
8. Participation in another clinical trial within the past 3 months, or receipt of other cell therapies (excluding blood transfusion);
9. History of malignant tumors;
10. Subjects with contraindications or cautions for estrogen use, including known or suspected breast cancer, endometrial cancer, other known or suspected sex hormone-dependent malignancies, active venous or arterial thromboembolic diseases within the last 6 months, undiagnosed abnormal genital bleeding, severe hepatic or renal insufficiency \[serum aspartate aminotransferase (AST) \>3×ULN, serum alanine aminotransferase (ALT) \>3×ULN, estimated glomerular filtration rate (eGFR) \<60 mL/min\], etc.;
11. Uncontrolled diabetes, hypertension (\>150/100 mmHg), heart disease, etc.;
12. Any other conditions judged by the investigator to render the subject unsuitable for participation in this study.

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Xiaohong Wang,MD
• Email: xiaohong@wingor.net
• Phone: +86 755 6683 5786

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Autologous Hair Follicle Secretome + PRP for POI

  This pilot study tests whether a patient’s own hair follicle secretome combined with their own platelet-rich plasma can improve ovarian function in women with premature ovarian insufficiency.

  Recruiting Phase 2 Trio Fertility · Toronto, Ontario · NCT07916740

• Human amniotic mesenchymal stem cell treatment for premature ovarian insufficiency

  This trial will test whether an intravenous infusion of human amniotic mesenchymal stem cells combined with standard hormone therapy can help women under 40 with premature ovarian insufficiency.

  Recruiting Phase 1/2 Changhai Hospital · Shanghai · NCT07115082

• Hormone replacement for adolescents with premature ovarian insufficiency

  This study will test estrogen patches plus progesterone in girls and young women aged 11–19 with premature ovarian insufficiency to see if hormone replacement improves bone density, metabolic markers, muscle strength, and cardiovascular health.

  Recruiting Phase 3 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT06851754

• Using Platelet-rich Plasma to Improve Female Fertility

  This study is testing whether injections of platelet-rich plasma can help improve fertility in women dealing with issues like poor ovarian response and repeated implantation failure.

  Recruiting The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Yiwu, Zhejiang · NCT06645379

• Using fat-derived cells to treat premature ovarian insufficiency

  This study is testing if using fat-derived cells can help improve pregnancy chances for women with premature ovarian insufficiency compared to standard IVF treatments.

  Recruiting Peking University Third Hospital · Beijing, Beijing Municipality · NCT06481969

• Examining the link between ovarian function and serum biomarkers

  This study is trying to see how blood markers differ between healthy women and those with ovarian issues to better understand their connection.

  Recruiting Dongzhimen Hospital, Beijing · Beijing · NCT06096766

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.