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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group 1 (Low dose CordSTEM-ST) | Experimental | Low dose CordSTEM-ST, 1 (single) administration |
|
| Study Group 2 (High dose CordSTEM-ST) | Experimental | High dose CordSTM-ST, 1 (single) administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| umbilical cord-derived mesenchymal stem cell | Biological | allogeneic umbilical cord-derived mesenchymal stem cell |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Number of adverse event cases reported | up to 6 months after the IP administration |
| Abnormality cases in lab test results | Number of clinically significant abnormalities found in lab test results. | up to 6 months after the IP administration |
| Abnormality cases physical exam results | Number of clinically significant abnormalities found in physical exam results | up to 6 months after the IP administration |
| Abnormality cases in vital signs | Number of clinically significant abnormalities found in vital signs | up to 6 months after the IP administration |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in blood Follicle Stimulating Hormone (FSH) level | blood Follicle Stimulating Hormone (FSH) level measured in mIU/ml | up to 6 months after the IP administration |
| Percent change from baseline in blood Anti-Mullerian Hormone (AMH) level |
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Inclusion Criteria:
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.
female subjects
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Bundang Medical Center | Seongnam-si | Gyeonggi-do | 463-712 | South Korea |
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| ID | Term |
|---|---|
| D016649 | Primary Ovarian Insufficiency |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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|
blood Anti-Mullerian Hormone (AMH) level measured in ng/ml |
| up to 6 months after the IP administration |
| Percent change from baseline blood Estradiaol (E2) level | blood Estradiaol (E2) level measured in pg/ml | up to 6 months after the IP administration |
| Percent change from baseline in number of mature follicles | number of mature follicles measured in number of follicles | up to 6 months after the IP administration |
| Percent change from baseline in number of antral follicles | number of antral follicles measured in number of follicles | up to 6 months after the IP administration |
| Percent change from baseline in endometrial thickness | endometrial thickness measured in cm | up to 6 months after the IP administration |
| Status of menstruation resumption | Collected by patient interview | up to 6 months after the IP administration |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |