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

Premature Ovarian Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03816852
• Other study ID #: SCLnow-HNRM-01
• Status: Suspended
• Phase: Phase 2
• Start date: October 1, 2018
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: Sclnow Biotechnology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 12
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Birth
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

Biological:
• hucMSCs
Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion

Locations

Country	Name	City	State
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Sclnow Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menstrual changes	Observe the change of patients with irregular menstrual cycle	270 days
Secondary	Kupperman score	Mild: <14; moderate: 14-26; serious: >26	270 days
Secondary	hormone level	Test the level change of Follicle-Stimulating Hormone (FSH), estrogen (E2), and Anti Mullerian Hormone (AMH)	270 days
Secondary	Follicular development	Observe the size of ovarian follicles in each cycle.	270 days