Premature Ovarian Insufficiency
Conditions
Keywords
Stem cell therapy, allogeneic stem cell, umbilical cord derived mesenchymal stem cell
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.
Interventions
allogeneic umbilical cord-derived mesenchymal stem cell
Sponsors
CHABiotech CO., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 39 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | up to 6 months after the IP administration | Number of adverse event cases reported |
| Abnormality cases in lab test results | up to 6 months after the IP administration | Number of clinically significant abnormalities found in lab test results. |
| Abnormality cases physical exam results | up to 6 months after the IP administration | Number of clinically significant abnormalities found in physical exam results |
| Abnormality cases in vital signs | up to 6 months after the IP administration | Number of clinically significant abnormalities found in vital signs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change from baseline blood Estradiaol (E2) level | up to 6 months after the IP administration | blood Estradiaol (E2) level measured in pg/ml |
| Status of menstruation resumption | up to 6 months after the IP administration | Collected by patient interview |
| Percent change from baseline in number of antral follicles | up to 6 months after the IP administration | number of antral follicles measured in number of follicles |
| Percent change from baseline in number of mature follicles | up to 6 months after the IP administration | number of mature follicles measured in number of follicles |
| Percent change from baseline in endometrial thickness | up to 6 months after the IP administration | endometrial thickness measured in cm |
| Percent change from baseline in blood Follicle Stimulating Hormone (FSH) level | up to 6 months after the IP administration | blood Follicle Stimulating Hormone (FSH) level measured in mIU/ml |
| Percent change from baseline in blood Anti-Mullerian Hormone (AMH) level | up to 6 months after the IP administration | blood Anti-Mullerian Hormone (AMH) level measured in ng/ml |
Countries
South Korea
Outcome results
None listed