Clinical trial NCT06578039: Phase 1 Clinical Trial of CordSTEM-ST
Official title: Single-dose, Phase 1 Clinical Trial to Evaluate the Safety, and Tolerability of Allogeneic Umbilical Cord-derived Mesenchymal Stem Cell Therapy in Patients With Premature Ovarian Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Premature Ovarian Insufficiency
Keywords: Stem cell therapy
allogeneic stem cell
umbilical cord derived mesenchymal stem cell
Lead sponsor: CHABiotech CO., Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-29
Enrollment: 6
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of adverse events
timeFrame: up to 6 months after the IP administration
measure: Abnormality cases in lab test results
timeFrame: up to 6 months after the IP administration
measure: Abnormality cases physical exam results
timeFrame: up to 6 months after the IP administration
measure: Abnormality cases in vital signs
timeFrame: up to 6 months after the IP administration
Secondary outcomes:
measure: Percent change from baseline in blood Follicle Stimulating Hormone (FSH) level
timeFrame: up to 6 months after the IP administration
measure: Percent change from baseline in blood Anti-Mullerian Hormone (AMH) level
timeFrame: up to 6 months after the IP administration
measure: Percent change from baseline blood Estradiaol (E2) level
timeFrame: up to 6 months after the IP administration
measure: Percent change from baseline in number of mature follicles
timeFrame: up to 6 months after the IP administration
measure: Percent change from baseline in number of antral follicles
timeFrame: up to 6 months after the IP administration
measure: Percent change from baseline in endometrial thickness
timeFrame: up to 6 months after the IP administration
measure: Status of menstruation resumption
timeFrame: up to 6 months after the IP administration
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Gyeonggi-do
Study officials:
References: