Status:
COMPLETED
Phase 1 Clinical Trial of CordSTEM-ST
Lead Sponsor:
CHABiotech CO., Ltd
Conditions:
Premature Ovarian Insufficiency
Eligibility:
FEMALE
25-39 years
Phase:
PHASE1
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 t...
Detailed Description
3 or 6 subjects will be enrolled sequentially by applying the "traditional 3+3 design" to evaluate the dose limiting toxicities (DLTs) for 28 days from the first administration date of the investigati...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
August 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2025
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06578039
Start Date
August 30 2024
End Date
April 28 2025
Last Update
November 19 2025
Active Locations (1)
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1
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea, 463-712