NCT06578039

Brief Summary

This clinical study will evaluate the safety and tolerability of CordSTEM-ST after administering a single dose in patients with premature ovarian insufficiency (POI), as well as identify the maximum tolerated dose (MTD) and evaluate the potential therapeutic effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2024

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

August 30, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2025

Completed
Last Updated

November 19, 2025

Status Verified

August 1, 2024

Enrollment Period

8 months

First QC Date

August 26, 2024

Last Update Submit

November 17, 2025

Conditions

Premature Ovarian Insufficiency

Keywords

Stem cell therapyallogeneic stem cellumbilical cord derived mesenchymal stem cell

Outcome Measures

Primary Outcomes (4)

  • Number of adverse events

    Number of adverse event cases reported

    up to 6 months after the IP administration

  • Abnormality cases in lab test results

    Number of clinically significant abnormalities found in lab test results.

    up to 6 months after the IP administration

  • Abnormality cases physical exam results

    Number of clinically significant abnormalities found in physical exam results

    up to 6 months after the IP administration

  • Abnormality cases in vital signs

    Number of clinically significant abnormalities found in vital signs

    up to 6 months after the IP administration

Secondary Outcomes (7)

  • Percent change from baseline in blood Follicle Stimulating Hormone (FSH) level

    up to 6 months after the IP administration

  • Percent change from baseline in blood Anti-Mullerian Hormone (AMH) level

    up to 6 months after the IP administration

  • Percent change from baseline blood Estradiaol (E2) level

    up to 6 months after the IP administration

  • Percent change from baseline in number of mature follicles

    up to 6 months after the IP administration

  • Percent change from baseline in number of antral follicles

    up to 6 months after the IP administration

  • +2 more secondary outcomes

Study Arms (2)

Study Group 1 (Low dose CordSTEM-ST)

EXPERIMENTAL

Low dose CordSTEM-ST, 1 (single) administration

Biological: umbilical cord-derived mesenchymal stem cell

Study Group 2 (High dose CordSTEM-ST)

EXPERIMENTAL

High dose CordSTM-ST, 1 (single) administration

Biological: umbilical cord-derived mesenchymal stem cell

Interventions

umbilical cord-derived mesenchymal stem cellBIOLOGICAL

allogeneic umbilical cord-derived mesenchymal stem cell

Also known as: CordSTEM-ST
Study Group 1 (Low dose CordSTEM-ST)Study Group 2 (High dose CordSTEM-ST)

Eligibility Criteria

Age25 Years - 39 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale subjects
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Females aged ≥ 25 years and \< 40 years
  • Individuals diagnosed with premature ovarian insufficiency: Individuals who have a follicle stimulating hormone (FSH) level of 40 IU/L or higher in the results of two tests conducted at least 4 weeks apart and are amenorrheic for at least 4 months
  • Individuals who voluntarily decide to participate and provide written consent

You may not qualify if:

  • Individuals diagnosed with primary amenorrhea\*
  • \* No secondary sex characteristics by age 13, Absence of menarche for 5 years after initial breast development, or Absence of menstruation by age 15
  • Individuals diagnosed with polycystic ovary syndrome
  • Individuals with any other conditions that may affect the result of this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 463-712, South Korea

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 Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2024

First Posted

August 29, 2024

Study Start

August 30, 2024

Primary Completion

April 28, 2025

Study Completion

April 28, 2025

Last Updated

November 19, 2025

Record last verified: 2024-08

Locations

KR(1)