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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT03816852
Other study ID # SCLnow-HNRM-01
Secondary ID
Status Suspended
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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