CompletedPhase 1

Phase 1 Clinical Trial of CordSTEM-ST

South Korea6 participantsStarted 2024-08-30

Plain-language 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.

Who can participate

Age range25 Years – 39 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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.

What they're measuring

Number of adverse events

Timeframe: up to 6 months after the IP administration

Abnormality cases in lab test results

Timeframe: up to 6 months after the IP administration

Abnormality cases physical exam results

Timeframe: up to 6 months after the IP administration

Abnormality cases in vital signs

Timeframe: up to 6 months after the IP administration

Trial details

NCT IDNCT06578039

SponsorCHABiotech CO., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-28

View on ClinicalTrials.gov More Premature Ovarian Insufficiency trials