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

Clinical Study on the Safety and Effectiveness of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency

Status

Suspended

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03816852

Enrollment

Registered

2019-01-25

Start date

2018-10-01

Completion date

2027-06-30

Last updated

2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Ovarian Failure

Keywords

Premature Ovarian Failure, Premature Ovarian Insufficiency, mesenchymal stem cell

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.

Interventions

BIOLOGICALhucMSCs

Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

19 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Menstrual changes	270 days	Observe the change of patients with irregular menstrual cycle

Secondary

Measure	Time frame	Description
Kupperman score	270 days	Mild: \<14; moderate: 14-26; serious: \>26
hormone level	270 days	Test the level change of Follicle-Stimulating Hormone (FSH), estrogen (E2), and Anti Mullerian Hormone (AMH)
Follicular development	270 days	Observe the size of ovarian follicles in each cycle.

Countries

China

Contacts

STUDY_DIRECTORGuangzhi Liu, Dr

Henan Provincial People's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026