Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04812431
Status:
RECRUITING
Last Update Posted:
2022-05-05
First Post:
2021-02-24
Brief Title:
Safety and Exploratory Efficacy of Transplantation Therapy Using PSA-NCAM NPC in AIS-A Level of Sub-acute SCI
Sponsor:
SBiomedics Co Ltd
Organization:
SBiomedics Co Ltd
Study Overview
Official Title:
A Single Center Open Label Single Group Phase 12a Clinical Study to Evaluate the Safety and Exploratory Efficacy of Transplantation Therapy Using PSA-NCAM NPC Derived From hESC Line in AIS-A Level of Sub-acute SCIFrom 7 to 60 Days
Status:
RECRUITING
Status Verified Date:
2024-09
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:
SB-SCI-001
Brief Summary:
This study intends to evaluate the safety and exploratory efficacy of transplantation therapy using neural precursor cells PSA-NCAM NPC derived from the human embryonic stem cell line for the treatment of paralysis and other related symptoms from sub-acute spinal cord injury
Detailed Description:
Subjects with damage to C4-C7 cords diagnosed as AIS-A are administered with PSA-NCAM NPC
For evaluation of safety and exploratory efficacy 2 to 6 subjects will be enrolled depending on the presentation of dose-limiting toxicity
When the Dose Limiting Toxicity DLT is not presented in the first three subjects administered with PSA-NCAM NPC two additional patients are added to the clinical study When the DLT is presented in two or more of the first three patients the clinical study is discontinued when the DLT is presented in one of the three patients three additional new patients are added In case of presentation of the DLT in at least one of the three additional patients the study is discontinued the clinical study is continued only when the DLT is not presented in all three patients
Screening visit Visit 1 surgery and recovery visit Visit 2 to Visit 6 follow-up visit Visit 7 to Visit 8 phone screening I II III additional visit Visit 9 to Visit 10 and close-out visit Visit 11 are conducted A clinical study period of at least 68 weeks is secured after Visit 6 at least 5 visits and 3 phone screenings
All subjects are to be conducted of follow-up study of a period of 1 year and 5 months at Weeks 1 2 4 8 12 24 48 and 72 after surgery
For evaluation of safety and exploratory efficacy 2 to 6 subjects will be enrolled depending on the presentation of dose-limiting toxicity
When the Dose Limiting Toxicity DLT is not presented in the first three subjects administered with PSA-NCAM NPC two additional patients are added to the clinical study When the DLT is presented in two or more of the first three patients the clinical study is discontinued when the DLT is presented in one of the three patients three additional new patients are added In case of presentation of the DLT in at least one of the three additional patients the study is discontinued the clinical study is continued only when the DLT is not presented in all three patients
Screening visit Visit 1 surgery and recovery visit Visit 2 to Visit 6 follow-up visit Visit 7 to Visit 8 phone screening I II III additional visit Visit 9 to Visit 10 and close-out visit Visit 11 are conducted A clinical study period of at least 68 weeks is secured after Visit 6 at least 5 visits and 3 phone screenings
All subjects are to be conducted of follow-up study of a period of 1 year and 5 months at Weeks 1 2 4 8 12 24 48 and 72 after surgery
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