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RECRUITING
NCT04812431
PHASE1/PHASE2

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

Sponsor: S.Biomedics Co., Ltd.

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

5

Start Date

2021-09-23

Completion Date

2030-09

Last Updated

2025-05-18

Healthy Volunteers

No

Interventions

BIOLOGICAL

Neural precursor cells derived from human embryonic stem cell line

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.

Locations (2)

Ajou University Hospital

Suwon, Gyeonggido, South Korea

Yonsei University Health System, Severance Hospital

Seoul, South Korea