Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578039
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Phase 1 Clinical Trial of CordSTEM-ST
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CBT210-POI_P1
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 33 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 50
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None