Safety and Exploratory Efficacy of Transplantation Therapy Using PSA-NCAM(+) NPC in AIS-A Level of Sub-acute SCI — SB-SCI-001  

Spinal Cord Injury, Acute Clinical Trial

Official title: A Single Center, Open Label, Single Group, Phase 1/2a 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 SCI(From 7 to 60 Days)

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury at C4 Level With Complete Lesion
• Spinal Cord Injury at C5-C7 Level With Complete Lesion
• Spinal Cord Injury, Acute
• Wounds and Injuries

• NCT number: NCT04812431
• Study type: Interventional
• Source: S.Biomedics Co., Ltd.
• Contact: Sarang Kim
• Phone: +82 70-2205-0023
• Email: info@sbiomedics.com
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 23, 2021
• Completion date: September 2028