The Safety and Efficiency Study of Mesenchymal Stem Cell (19#iSCLife®-POI) in Premature Ovarian I… (NCT03816852) | Clinical Trial Compass
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 range19 Years – 40 Years
SexFEMALE
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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