Clinical trial NCT03816852: The Safety and Efficiency Study of Mesenchymal Stem Cell (19#iSCLife®-POI) in Premature Ovarian Insufficiency
Official title: Clinical Study on the Safety and Effectiveness of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Premature Ovarian Failure
Keywords: Premature Ovarian Failure
Premature Ovarian Insufficiency
mesenchymal stem cell
Lead sponsor: Sclnow Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-01-25
Enrollment: 12
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Menstrual changes
timeFrame: 270 days
Secondary outcomes:
measure: Kupperman score
timeFrame: 270 days
measure: hormone level
timeFrame: 270 days
measure: Follicular development
timeFrame: 270 days
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
Study officials:
affiliation: Henan Provincial People's Hospital
name: Guangzhi Liu, Dr
role: STUDY_DIRECTOR
References: