SuspendedPhase 2

The Safety and Efficiency Study of Mesenchymal Stem Cell (19#iSCLife®-POI) in Premature Ovarian Insufficiency

Stopped: Others

China12 participantsStarted 2018-10-01

Plain-language 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.

Who can participate

Age range

19 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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; * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Menstrual changes

Timeframe: 270 days

Trial details

NCT IDNCT03816852

SponsorSclnow Biotechnology Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Premature Ovarian Failure trials