Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04661644
Status:
COMPLETED
Last Update Posted:
2023-12-27
First Post:
2020-11-20
Brief Title:
Efficacy and Safety of Mesenchymal Stem Cell Clusters in Patients with Critical Limb Ischemia
Sponsor:
SBiomedics Co Ltd
Organization:
SBiomedics Co Ltd
Study Overview
Official Title:
A Phase 12a Clinical Trial to Evaluate the Efficacy and Safety of Allogenic Adipose Tissue-derived Mesenchymal Stem Cell Clusters in Patients with Critical Limb Ischemia
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial is designed as a Phase 12a clinical trial targeting patients with critical limb ischemia The trial is composed of Phase 1 to assess the tolerability and safety and Phase 2a to assess the safety and efficacy of the investigational productA cluster of adipose-derived mesenchymal stem cells 3D-A cluster of adipose- derived mesenchymal stem cells and proceeds in that order
Detailed Description:
This clinical trial is designed as a Phase 12a clinical trial targeting patients with critical limb ischemia The trial is composed of Phase 1 to assess the tolerability and safety and Phase 2a to assess the safety and efficacy of the investigational product
Phase 1 Open-label 3 3 design single-center This phase is conducted in a 3 3 design by dose level to evaluate the tolerability of the investigational product
If the subject voluntarily agrees signs the informed consent formin writing to participate in this clinical trial the subjects who had necessary check-ups and tests and meet the inclusion criteria after subject conformity assessment are registered in the clinical trialThe subjects receive the investigational product once and are checked for adverse events through day 1 and then discharged The safety and efficacy assessments are conducted through visits at week 4 week 12 and week 24 after administration
Subjects are evaluated for adverse events up to week 4 after the administration of the investigational product by registering 3 subjects each at the dosing phase This evaluation is conducted according to the number of persons subjects who developed Grade 3 or higher adverse drug reactions ADRs according to CTCAE Version_50 in which a causal relation with the investigational product cannot be ruled out
If the maximum tolerated dose MTD is determined with the test group 2 high dose in the Phase 1 clinical trial the Phase 2a clinical trial will be conducted with the two groups test group 2 and test group 1
However if adverse events occur in 1 of 6 subjects the test group 2 will be decided considered as the maximum tolerated dose MTD or but only the test group 1 will proceed to Phase 2a
If adverse events occur in 2 or more subjects out of 6 subjects a dose smaller than test group 1 low dose is determined to be the maximum tolerated dose The Phase 2a clinical trial will not proceed and the clinical trial will end
Phase 2a Open-label sequential assignment single-center If tolerability and safety are secured 4 weeks after administration of the investigational product of Phase 1 Phase 2a is conducted
Only those subjects meeting the final inclusion criteria are sequentially assigned admitted by the same procedure and administered the investigational product once Subjects are checked for adverse events through day 1 and discharged Safety and efficacy assessments are performed at week 4 week 12 and week 24 after administration All subjects are tested with the same schedule excluding their doses
The subjects enrolled in Phase 1 are analyzed for efficacy through visits at week 12 and week 24 so that all subjects Phase 1 and Phase 2a are assessed and analyzed for efficacy
Phase 1 Open-label 3 3 design single-center This phase is conducted in a 3 3 design by dose level to evaluate the tolerability of the investigational product
If the subject voluntarily agrees signs the informed consent formin writing to participate in this clinical trial the subjects who had necessary check-ups and tests and meet the inclusion criteria after subject conformity assessment are registered in the clinical trialThe subjects receive the investigational product once and are checked for adverse events through day 1 and then discharged The safety and efficacy assessments are conducted through visits at week 4 week 12 and week 24 after administration
Subjects are evaluated for adverse events up to week 4 after the administration of the investigational product by registering 3 subjects each at the dosing phase This evaluation is conducted according to the number of persons subjects who developed Grade 3 or higher adverse drug reactions ADRs according to CTCAE Version_50 in which a causal relation with the investigational product cannot be ruled out
If the maximum tolerated dose MTD is determined with the test group 2 high dose in the Phase 1 clinical trial the Phase 2a clinical trial will be conducted with the two groups test group 2 and test group 1
However if adverse events occur in 1 of 6 subjects the test group 2 will be decided considered as the maximum tolerated dose MTD or but only the test group 1 will proceed to Phase 2a
If adverse events occur in 2 or more subjects out of 6 subjects a dose smaller than test group 1 low dose is determined to be the maximum tolerated dose The Phase 2a clinical trial will not proceed and the clinical trial will end
Phase 2a Open-label sequential assignment single-center If tolerability and safety are secured 4 weeks after administration of the investigational product of Phase 1 Phase 2a is conducted
Only those subjects meeting the final inclusion criteria are sequentially assigned admitted by the same procedure and administered the investigational product once Subjects are checked for adverse events through day 1 and discharged Safety and efficacy assessments are performed at week 4 week 12 and week 24 after administration All subjects are tested with the same schedule excluding their doses
The subjects enrolled in Phase 1 are analyzed for efficacy through visits at week 12 and week 24 so that all subjects Phase 1 and Phase 2a are assessed and analyzed for efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None