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Safety Evaluation of LSCD101 Transplantation for Limbal Stem Cell Deficiency

NCT04773431 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-02-26

No results posted yet for this study

Summary

Clinical Study Objective:

To evaluate the tolerability and safety after transplantation of LSCD101 in patients with intractable limbal stem cell deficiency

Study Method:

Subjects who finally meet the inclusion/exclusion criteria results of the subject eligibility evaluation will receive transplantation of the investigational product. Adverse drug reaction will be confirmed during 24 weeks after transplantation.

Conditions

  • Limbus Corneae
  • Limbus Corneae Insufficiency Syndrome

Interventions

DRUG

LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation

LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) is transplanted in the lesion.

Sponsors & Collaborators

  • CliPS Co., Ltd

    lead INDUSTRY

Principal Investigators

  • SoHyang Chung, MD,Ph.D · The Catholic University of Korea

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2021-01-14
Completion
2021-01-14

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 NCT04773431 on ClinicalTrials.gov