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

NCT04812431 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-05-18

No results posted yet for this study

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.

Conditions

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

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.

Sponsors & Collaborators

  • Linical Co., Ltd.

    collaborator INDUSTRY

  • Yonsei University

    collaborator OTHER

  • S.Biomedics Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Dong Ah Shin, MD · Yonsei University Health System, Severance Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-23
Primary Completion
2028-10-31
Completion
2030-09-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04812431 on ClinicalTrials.gov