NCT04773431

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
Last Updated

February 26, 2021

Status Verified

January 1, 2021

Enrollment Period

12 months

First QC Date

January 22, 2021

Last Update Submit

February 24, 2021

Conditions

Limbus CorneaeLimbus Corneae Insufficiency Syndrome

Outcome Measures

Primary Outcomes (1)

  • Rate of Adverse event

    Adverse event

    From limbal tissue collection until 24 weeks after transplantation

Secondary Outcomes (7)

  • Rate of normal/abnormal results in clinical laboratory test

    Before treatment, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation

  • Blood pressure(systolic/diastolic) at each visit

    Before treatment, 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation

  • Pulse rate at each visit

    Before treatment, 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation

  • Rate of normal/abnormal results in Electrocardiogram

    Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation

  • Rate of normal/abnormal results in physical examination at each visit

    Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation

  • +2 more secondary outcomes

Study Arms (1)

LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation

EXPERIMENTAL

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

Drug: LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation

Interventions

LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantationDRUG

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

LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women aged 19 or older
  • Diagnosed with intractable limbal stem cell deficiency in single eye, with severity in which corneal neovascularization invades more than two quadrants
  • No improvement of indication by known treatment (non-surgical/surgical) method according to investigator's judgment
  • BCVA 20/40 or less at screening in the eye with the limbal stem cell deficiency
  • Voluntarily agreed to participate in this study and signed a consent form

You may not qualify if:

  • Inappropriate for harvesting limbal epithelial cells for the production of limbal epithelial cell sheet.
  • Difficulty in reconstruction of the corneal epithelium because the eye is not closed due to eyelid function problems in the eye with the limbal stem cell deficiency.
  • Severe dry eye with problem with tear secretion in both eyes (value of Schirmer I test without anesthesia \< 2 mm/5 min at screening)
  • Acute ocular surface inflammation of both corneas at Visit 2
  • Malignant tumor history (except in case of no recurrence more than 5 years after surgery)
  • Uncontrolled comorbidities such as moderate to severe infections and bleeding
  • Positive for virus infection (HBV, HCV, HIV, CMV, HTLVⅠ/Ⅱ, syphilis)
  • Uncontrolled diabetes (HbA1c ≥9.0%)
  • Uncontrolled hypertension (SBP \> 140 mmHg or DBP \> 90 mmHg despite taking antihypertensives at screening)
  • Uncontrolled glaucoma (IOP \> 21 mmHg despite taking glaucoma medication)
  • Pregnant or lactating women
  • Women with childbearing potential, those who do not agree to contraception by medically accepted contraceptive methods during clinical trials
  • Participation in another clinical study within 4 weeks
  • Subjects judged by the investigator to be inappropriate to participate in the clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CliPS

Seoul, 04168, South Korea

Location

MeSH Terms

Interventions

Transplantation

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • SoHyang Chung, MD,Ph.D

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2021

First Posted

February 26, 2021

Study Start

January 31, 2020

Primary Completion

January 14, 2021

Study Completion

January 14, 2021

Last Updated

February 26, 2021

Record last verified: 2021-01

Locations

KR(1)