The Safety and Efficiency Study of Mesenchymal Stem Cell... | NCT03816852

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

NCT03816852

Sponsor

Sclnow Biotechnology Co., Ltd.

Status

Suspended

Last Update Posted

Apr 23, 2026Actual

Enrollment

12Estimated

Phase

Phase 2

Conditions

Premature Ovarian Failure

Interventions

hucMSCs

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Others

Expanded Access Info

Start Date

Oct 1, 2018Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Jun 30, 2027Estimated

First Submitted Date

Jan 17, 2019

First Submission Date that Met QC Criteria

Jan 24, 2019

First Posted Date

Jan 25, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2026

Last Update Posted Date

Apr 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High dose group	Experimental	Intravenous infusion with hucMSCs, 9*10^7 cells, 30ml	Biological: hucMSCs
Medium dose group	Experimental	Intravenous infusion with hucMSCs, 6*10^7 cells, 30ml	Biological: hucMSCs
Low dose group	Experimental	Intravenous infusion with hucMSCs, 3*10^7 cells, 30ml	Biological: hucMSCs

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hucMSCs	Biological	Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion	High dose group Low dose group Medium dose group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guangzhi Liu, Dr	Henan Provincial People's Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Henan Provincial People's Hospital		Zhengzhou	Henan	450003	China

Condition Browse Module

MeSH Terms

ID	Term
D016649	Primary Ovarian Insufficiency

Ancestor Terms

ID	Term
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases

Browse Leaves

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Browse Branches

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