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

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.

Study Overview

• Status: Suspended
• Conditions: Premature Ovarian Failure
• Intervention / Treatment: Biological: hucMSCs

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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Henan Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High dose group; Intravenous infusion with hucMSCs, 9*10^7 cells, 30ml	Biological: hucMSCs; Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion
Experimental: Medium dose group; Intravenous infusion with hucMSCs, 6*10^7 cells, 30ml	Biological: hucMSCs; Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion
Experimental: Low dose group; Intravenous infusion with hucMSCs, 3*10^7 cells, 30ml	Biological: hucMSCs; Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sclnow Biotechnology Co., Ltd.
• Investigators: Study Director: Guangzhi Liu, Dr, Henan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: mesenchymal stem cell; Premature Ovarian Failure; Premature Ovarian Insufficiency
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Primary Ovarian Insufficiency
• Other Study ID Numbers: SCLnow-HNRM-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No