NCT03816852

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.

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
13mo left

Started Oct 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Oct 2018Jun 2027

Study Start

First participant enrolled

October 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

April 23, 2026

Status Verified

December 1, 2025

Enrollment Period

8.3 years

First QC Date

January 17, 2019

Last Update Submit

April 22, 2026

Conditions

Premature Ovarian Failure

Keywords

Premature Ovarian FailurePremature Ovarian Insufficiencymesenchymal stem cell

Outcome Measures

Primary Outcomes (1)

  • Menstrual changes

    Observe the change of patients with irregular menstrual cycle

    270 days

Secondary Outcomes (3)

  • Kupperman score

    270 days

  • hormone level

    270 days

  • Follicular development

    270 days

Study Arms (3)

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

hucMSCsBIOLOGICAL

Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion

High dose groupLow dose groupMedium dose group

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Guangzhi Liu, Dr

    Henan Provincial People's Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2019

First Posted

January 25, 2019

Study Start

October 1, 2018

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

April 23, 2026

Record last verified: 2025-12

Locations

CN(1)