NCT07775391 Phase Ⅰ/Ⅱa Trial Evaluating Intravenous hUC-MSCs Injection for Safety, Tolerability and Efficacy in Patients With POI
| NCT ID | NCT07775391 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shenzhen Wingor Biotechnology Co., Ltd. |
| Condition | Premature Ovarian Insufficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 59 participants |
| Start Date | 2026-08-03 |
| Primary Completion | 2028-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 59 participants in total. It began in 2026-08-03 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Phase I/IIa clinical study evaluating the safety, tolerability and efficacy of intravenously administered human umbilical cord mesenchymal stem cell (hUC-MSCs) injection in patients with premature ovarian insufficiency (POI). The primary objective of the Phase I dose-escalation stage is to assess the safety and tolerability of intravenous infusion of hUC-MSCs injection for the treatment of POI, and to determine the recommended phase II dose (RP2D) for the Phase IIa clinical trial. The primary objective of the Phase IIa dose-expansion stage is to evaluate the efficacy of intravenous infusion of hUC-MSCs injection in POI treatment, and to generate data to support pivotal/confirmatory clinical trials.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07775391 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Premature Ovarian Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07775391 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07775391 currently recruiting?
Yes, NCT07775391 is actively recruiting participants. Contact the research team at xiaohong@wingor.net for enrollment information.
Where is the NCT07775391 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07775391 clinical trial?
NCT07775391 is sponsored by Shenzhen Wingor Biotechnology Co., Ltd.. The trial plans to enroll 59 participants.