phase 1/2a clinical study to evaluate the safety and exploratory efficacy for PSA-NCAM (+) NPC

General Information
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. This clinical study is a single center, open label, single group, phase 1/2a clinical study conducted to evaluate the safety and exploratory efficacy of transplant of PSA-NCAM(+) NPC in patients with sub-acute spinal cord injury. Upon written consent by the subject of voluntary participation in the clinical study, participation in the clinical study is determined by conducting necessary examinations and tests 4 to 14 days before administration of the investigational product in accordance with the protocol. Re-evaluation for conformity is conducted 1 to 3 days prior to administration of the investigational product for maintenance of suitability, and subjects with damage to C4-C7 cords diagnosed as AIS-A are administered with PSA-NCAM(+) NPC. 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 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). The allowed period of visits scheduled thereafter is ±3 days for Visits 4 to 6, ±7 days for Visits 7 to 8, and ±14 days for Visits 9 to 11. 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.
Clinical trials phase	Phases 1/2
Start date (estimated)	2021-02-08
End date (estimated)	2024-02-01
Clinical feature	Label Spinal cord injury Link http://www.orpha.net/ORDO/Orphanet_90058
Administrative Information
NCT number	NCT04812431
ICTRP weblink	https://trialsearch.who.int/Trial2.aspx?TrialID=KCT0005628
Sponsor Protocol number	HI20C0168000020 (Unique Protocol ID)
Other study identifiers	Name KCT0005628 Description Clinical Research Information Service (CRIS) Name SB-SCI-001 Description Acronym
Source weblink	https://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=18494
Regulatory body approval	Name Yonsei University Health System, Severance Hospotal, Institutional Review Board Country South Korea
Approval number	4-2020-0691
Study sites	Yonsei University Health System, Severance Hospital
Public contact	Email cistern@yuhs.ac Public email cistern@yuhs.ac First name Dong Ah Last name Shin Phone +82-2-2228-2150 City Seoul Country South Korea Address freetext Yonsei University Health System, Severance Hospital 50-1, Yonsei-ro, Seodaemun-gu, Seoul, South Korea
Sponsors	S.Biomedics
Cells
Which differentiated cell type is used	Label neural progenitor cell Link http://purl.obolibrary.org/obo/CL_0011020 Description An undifferentiated cell that originates from a neural stem cell and has the capacity to generate multiple types of lineage-restricted progenitors but not to self-renew.
Recruitment
Recruitment Status	Recruiting
Estimated number of participants	5