Phase 1 Clinical Trial of CordSTEM-ST

NCT ID: NCT06578039

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-30
• Study Completion Date: 2025-04-28

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.

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 investigational product according to the protocol. A DLT is defined as the occurrence of a grade 3 or higher adverse drug reaction (ADR) according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

First three subjects will be enrolled in Study Group 1 (low dose group) to be evaluated for DLTs up to 28 days after IP administration. If none of three subjects develope DLT, three subjects for Study Group 2 (high dose group) will be recruited. If one out of three subjects in Study Group 1 develop DLT, additional three subjects in Study Group 1 will be enrolled to be evaluated for DLT. If two or more subjects develop DLT in initial three subjects, the study will be terminated.

This study will be followed up by a long-term follow-up study under the separate protocol.

Conditions

Premature Ovarian Insufficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Group 1 (Low dose CordSTEM-ST)

Low dose CordSTEM-ST, 1 (single) administration

Group Type: EXPERIMENTAL

umbilical cord-derived mesenchymal stem cell

Intervention Type: BIOLOGICAL

allogeneic umbilical cord-derived mesenchymal stem cell

Study Group 2 (High dose CordSTEM-ST)

High dose CordSTM-ST, 1 (single) administration

Group Type: EXPERIMENTAL

umbilical cord-derived mesenchymal stem cell

Intervention Type: BIOLOGICAL

allogeneic umbilical cord-derived mesenchymal stem cell

Interventions

umbilical cord-derived mesenchymal stem cell

allogeneic umbilical cord-derived mesenchymal stem cell

Intervention Type: BIOLOGICAL

Other Intervention Names

CordSTEM-ST

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CHABiotech CO., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

CBT210-POI_P1

Identifier Type: -

Identifier Source: org_study_id