Phase 1 Clinical Trial of CordSTEM-ST

Overview

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.

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

Interventions

Eligibility

Locations (1)

Outcomes