A Phase 1/2 interventional study of hUC-MSCs Injection (Phase I) and hUC-MSCs Injection (Phase IIa) in Premature Ovarian Insufficiency, sponsored by Shenzhen Wingor Biotechnology Co., Ltd.. Recruiting at 1 site in China. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Shenzhen Wingor Biotechnology Co., Ltd. · Phase 1/2, Interventional, and Treatment
Among 40 studies in Primary Ovarian Insufficiency with a site in China — 14 open to participants now, 16 under way, none of them phase 3. Primary Ovarian Insufficiency · China.
Among the 40 studies in Primary Ovarian Insufficiency with a site in China, this one is the 13th largest by planned enrollment of the 27 interventional ones that give a count, is one of 4 that started in 2026, is one of 8 in phase 1/2, reaches primary completion later than 13 of the 15 other live ones, and was the 38th registered.
181 studies on the registry are indexed under Primary Ovarian Insufficiency; 48 are open to participants now.
Browse Primary Ovarian Insufficiency studies →14 of the 40 studies in Primary Ovarian Insufficiency with a site in China are open now. Recruiting first, the newest first:
The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Sites in China
Ages 18–50 · Women only
Yan Hongli · Sites in China
Ages 20–40 · Women only
Rui Yang · Sites in China
Ages 20–39 · Women only
Shi Yun · Sites in China
Ages 18–39 · Women only
Shi Yun · Sites in China
Ages 18–45 · Women only · Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 27 Primary Ovarian Insufficiency studies recruiting now, 1 (4%) sets no upper age limit and 24 (89%) stop at 75 or younger; 8 take children under 18; 10 take healthy volunteers.
This study: 18 Years to 40 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
40 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 10 · Phase 4 2
First in 2012; this study’s year is marked. 4 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 59 is above the median of 48 across 113 interventional studies indexed under Primary Ovarian Insufficiency.
Median enrollment 50 across the 27 interventional studies, 260 across the 13 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 40 have an industry lead sponsor. The 10 most frequent:
Shenzhen Wingor Biotechnology Co., Ltd. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Shenzhen Wingor Biotechnology Co., Ltd. has 1 study filed under Primary Ovarian Insufficiency — fewer than ten, so there is no comparison to draw.
4 of the studies in Primary Ovarian Insufficiency with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07843030Shi YunEffect and Mechanism of Jiajian Guishen Optimized Formula on Premature Ovarian Insufficiency: Insights Into m6A Modification and Oxidative Stress | 2026-12-30 |
| NCT06481969Rui YangApplication of Autologous Adipose Stromal Vascular Fraction in the Treatment of Premature Ovarian Insufficiency | 2026-12-30 |
| NCT06067529Women's Hospital School Of Medicine Zhejiang UniversityA Multicenter Observational Study on the Development and Health Effects of Premature Ovarian Insufficiency | 2026-12-31 |
| NCT06645379The Fourth Affiliated Hospital of Zhejiang University School of MedicineApplication of Platelet-rich Plasma (PRP) in Reproductive Medicine | 2027-09-15 |
Add all 4 to your calendar (.ics) → With an account.
Among the 40 studies in Primary Ovarian Insufficiency with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Premature ovarian insufficiency (POI) is defined as ovarian dysfunction occurring in women before the age of 40, which is mainly characterized by menstrual abnormalities (amenorrhea, oligomenorrhea or polymenorrhea), elevated gonadotropin levels (FSH > 25 U/L), and fluctuating decline in estrogen levels. The incidence of POI is age-specific: 1 in 250 women develops POI before 35 years of age, and 1 in 100 women develops POI before 40 years of age. The incidence rate of POI in China is 2.8%, showing an upward trend year by year with a younger onset age.
hormone replacement therapy (HRT) relieves symptoms caused by low estrogen through estrogen supplementation. Sequential estrogen-progestogen therapy is recommended for POI patients with an intact uterus. Since patients with POI require long-term HRT, natural or nearly natural estrogens and progestogens can be selected to minimize adverse effects on the mammary gland, metabolism, cardiovascular system and other systems. Nevertheless, HRT still increases the risks of breast cancer, heart disease and stroke.
Studies have demonstrated that mesenchymal stem cells can home to ovarian stroma, regulate the balance of Th1/Th2 cytokines and the expression of endometrial natural killer cells, alleviate inflammatory responses, inhibit apoptosis of ovarian granulosa cells and reduce ovarian interstitial fibrosis, thereby improving the ovarian microenvironment. Meanwhile, these cells can secrete growth factors including VEGF, IGF-1 and HGF, promote proliferation of various ovarian cells and angiogenesis, repair ovarian structure and restore ovarian ovarian function. This study aims to evaluate the safety, tolerability and efficacy of intravenously administered hUC-MSCs in the treatment of patients with POI.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Satisfy one of the following two criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Human Umbilical Cord Mesenchymal Stem Cells Injection
Drug: hUC-MSCs Injection (Phase I)
Human Umbilical Cord Mesenchymal Stem Cells Injection
Drug: hUC-MSCs Injection (Phase I)
Human Umbilical Cord Mesenchymal Stem Cells Injection
Drug: hUC-MSCs Injection (Phase I)
Human Umbilical Cord Mesenchymal Stem Cells Injection
Drug: hUC-MSCs Injection (Phase IIa)
Human Umbilical Cord Mesenchymal Stem Cells Injection
Drug: hUC-MSCs Injection (Phase IIa)
Multiple Electrolytes Injection
Drug: Placebo
hUC-MSCs Injection, administered via intravenous infusion as a single dose on D0.
Also known as: hUC-MSCs
hUC-MSCs Injection, 3 infusions in total, dosing interval ≥7 days.
Also known as: hUC-MSCs
3 infusions in total, dosing interval ≥7 days
Phase I : Incidence and number of subjects with treatment-emergent adverse events and serious adverse events.
In this Phase I stage, safety is the primary endpoint. Types, frequencies, severities and causal relationships of all adverse events (AEs) and serious adverse events (SAEs) occurring from the first administration of study drug to the end of safety follow-up (48 weeks), assessed in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0; together with the proportion of adverse events judged by the investigator to be related to the study drug.
Time frame: 48 weeks
Phase II ：FSH
To evaluate the changes from baseline in serum follicle-stimulating hormone (FSH) levels at Week 24 post-treatment.
Time frame: at Week 24 post-treatment
Phase II ：E2
To evaluate the changes from baseline in serum festradiol (E2) levels at Week 24 post-treatment.
Time frame: at Week 24 post-treatment
Phase II ：AMH
To evaluate the changes from baseline in serum anti-Müllerian hormone (AMH) levels at Week 24 post-treatment.
Time frame: at Week 24 post-treatment
Phase I: FSH
To evaluate the changes from baseline in serum follicle-stimulating hormone (FSH) levels.
Time frame: 48 weeks
Phase I ：E2
To evaluate the changes from baseline in serum estradiol (E2) levels
Time frame: 48 weeks
Phase I : AMH
To evaluate the changes from baseline in serum anti-Müllerian hormone (AMH) levels.
Time frame: 48 weeks
Phase II: Incidence and number of subjects with treatment-emergent adverse events and serious adverse events.
In this Phase II stage, safety is the secondary endpoint. Types, frequencies, severities and causal relationships of all adverse events (AEs) and serious adverse events (SAEs) occurring from the first administration of study drug to the end of safety follow-up (48 weeks), assessed in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0; together with the proportion of adverse events judged by the investigator to be related to the study drug.
Time frame: 48 weeks
Phase I/II: AFC
Changes from baseline in antral follicle count (AFC) by transvaginal ultrasound.
Time frame: 48 weeks
Phase I/II: endometrial thickness
Changes from baseline in endometrial thickness measured by transvaginal ultrasound.
Time frame: 48 weeks
Phase I/II: menstrual recovery status
Menstrual recovery status will be assessed via patient inquiry at each visit.
Time frame: 48 weeks
Phase I/II:Modified Kupperman Index
To evaluate the changes in the Modified Kupperman Index from baseline across all post-baseline follow-up visits. Modified Kupperman Index will be assessed through physician interview.The total score ranges from 0 to 63 points. Total score stratification: \>30 points indicates severe symptoms, 16-30 points moderate symptoms, 6-15 points mild symptoms, and \<6 points normal status.
Time frame: 48 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Sep 2028, 25 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Solizmestrocel
Primary Ovarian Insufficiency →
Shenzhen Wingor Biotechnology Co., Ltd.