Premature Ovarian FailurePhase 2NCT03816852
The Safety and Efficiency Study of Mesenchymal Stem Cell (19#iSCLife®-POI) in Premature Ovarian Insufficiency
A Phase 2 study testing hucMSCs in people with Premature Ovarian Failure, run by Sclnow Biotechnology Co., Ltd. at 1 site in China.
Trial summary
Evaluate the safety of human umbilical cord mesenchymal stem cells (hucMSCs) in POI treatment; Evaluate the effective hucMSCs in POI treatment. Compare different infusion mode, meanwhile compare with hormone replacement therapy (HRT) withdrawal, so that assessing the stem cell therapy. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Premature Ovarian Failure
- What is being tested?
- hucMSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Meet diagnostic criteria of European Society of Human Reproduction and Embryology
- No hormonotherapy and chinese traditional medicine within 3 months;
- Understand and sign informed consent.
Who cannot join
- Patient with congenital adrenocortical hyperplasia;
- Patient with Cushing syndrome;
- Patient with Thyroid dysfunction;
- Patient with hyperprolactinemia;
- Patient with pituitary amenorrhea or hypothalamic amenorrhea;
- Patient with HIV, hepatitis;
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- Gene defect (eg. Turner syndrome, fragile X syndrome)
- Serious drug allergy history;
- Suffering from thrombophlebitis, thromboembolism including venous thrombosis and arterial thrombosis;
- History of treatment of ovarian cysts or ovarian surgery
- With high tumor marker;
- Pregnant or lactating
- Receive other treatments that may affect the efficacy and safety of stem cells;
- Do not understand or without sign informed consent;
- The attending physician believes that it is not suitable for participating in this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study on the Safety and Effectiveness of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency
Evaluate the safety of human umbilical cord mesenchymal stem cells (hucMSCs) in POI treatment; Evaluate the effective hucMSCs in POI treatment. Compare different infusion mode, meanwhile compare with hormone replacement therapy (HRT) withdrawal, so that assessing the stem cell therapy.
Read the detailed description
Premature ovarian insufficiency (POI) or premature ovarian failure (POF), is the loss of function of the ovaries before age 40, which has the features of menstrual disorder with high gonadotropic hormone and low estrogen. The morbidity of POI is about 0.1% among woman before 40 years, 10-28% among woman with primary amenorrhea, and 4-18% among woman with secondary amenorrhea. Recent years research shows different sources of stem cell could be used to POI, and with effective results.
Above all, this experiment designed to as a single center, random, and control experiment. treat POI patients wit human umbilical cord mesenchymal stem cells (MSCs). After regular follow-up and analysis, assessing the safety and effective of MSCs in POI treatment.
- Conditions
- Premature Ovarian Failure
- Being tested
- hucMSCs
- Keywords
- Premature Ovarian Failure, Premature Ovarian Insufficiency, mesenchymal stem cell
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hucMSCsBiological
Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| High dose group | Experimental | Intravenous infusion with hucMSCs, 9*10^7 cells, 30ml Receives: Biological: hucMSCs |
| Medium dose group | Experimental | Intravenous infusion with hucMSCs, 6*10^7 cells, 30ml Receives: Biological: hucMSCs |
| Low dose group | Experimental | Intravenous infusion with hucMSCs, 3*10^7 cells, 30ml Receives: Biological: hucMSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual changes
Observe the change of patients with irregular menstrual cycle
Measured: 270 days
Secondary outcomes (3)
Kupperman score
Mild: <14; moderate: 14-26; serious: >26
Measured: 270 days
hormone level
Test the level change of Follicle-Stimulating Hormone (FSH), estrogen (E2), and Anti Mullerian Hormone (AMH)
Measured: 270 days
Follicular development
Observe the size of ovarian follicles in each cycle.
Measured: 270 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start1 Oct 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Why it stopped: Others
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sclnow Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guangzhi Liu, Dr, Study director, Henan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816852
- Sponsor's protocol ID
- SCLnow-HNRM-01
- Status last verified
- Dec 2025
- First submitted
- 17 Jan 2019
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Effectiveness of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency
- ClinicalTrials.gov ID
- NCT03816852
- Acronym / sponsor ID
- SCLnow-HNRM-01
- Conditions
- Premature Ovarian Failure
- Keywords
- Premature Ovarian Failure, Premature Ovarian Insufficiency, mesenchymal stem cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Others
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Sclnow Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety of human umbilical cord mesenchymal stem cells (hucMSCs) in POI treatment; Evaluate the effective hucMSCs in POI treatment. Compare different infusion mode, meanwhile compare with hormone replacement therapy (HRT) withdrawal, so that assessing the stem cell therapy.
Detailed description
Premature ovarian insufficiency (POI) or premature ovarian failure (POF), is the loss of function of the ovaries before age 40, which has the features of menstrual disorder with high gonadotropic hormone and low estrogen. The morbidity of POI is about 0.1% among woman before 40 years, 10-28% among woman with primary amenorrhea, and 4-18% among woman with secondary amenorrhea. Recent years research shows different sources of stem cell could be used to POI, and with effective results.
Above all, this experiment designed to as a single center, random, and control experiment. treat POI patients wit human umbilical cord mesenchymal stem cells (MSCs). After regular follow-up and analysis, assessing the safety and effective of MSCs in POI treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose group | Experimental | Biological: hucMSCsIntravenous infusion with hucMSCs, 9*10^7 cells, 30ml |
| Medium dose group | Experimental | Biological: hucMSCsIntravenous infusion with hucMSCs, 6*10^7 cells, 30ml |
| Low dose group | Experimental | Biological: hucMSCsIntravenous infusion with hucMSCs, 3*10^7 cells, 30ml |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Meet diagnostic criteria of European Society of Human Reproduction and Embryology
- No hormonotherapy and chinese traditional medicine within 3 months;
- Understand and sign informed consent.
Key exclusion criteria (15 listed)
- Patient with congenital adrenocortical hyperplasia;
- Patient with Cushing syndrome;
- Patient with Thyroid dysfunction;
- Patient with hyperprolactinemia;
- Patient with pituitary amenorrhea or hypothalamic amenorrhea;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hucMSCsHuman umbilical cord mesenchymal stem cells were transplanted by intravenous infusion | Biological | High dose group, Low dose group, Medium dose group |
Primary outcome
Menstrual changes
Time frame: 270 days
Observe the change of patients with irregular menstrual cycle
3 secondary outcomes
Kupperman score
Time frame: 270 days
hormone level
Time frame: 270 days
Follicular development
Time frame: 270 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guangzhi Liu, Dr study director
Henan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hucMSCs in people with Premature Ovarian Failure, run by Sclnow Biotechnology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual changes (time frame: 270 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.