Safety Evaluation of LSCD101 Transplantation for Limbal Stem Cell Deficiency
Primary Purpose
Limbus Corneae, Limbus Corneae Insufficiency Syndrome
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Limbus Corneae
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- CliPS
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation
Arm Description
LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) is transplanted in the lesion.
Outcomes
Primary Outcome Measures
Rate of Adverse event
Adverse event
Secondary Outcome Measures
Rate of normal/abnormal results in clinical laboratory test
Comparisons between pre-/post- transplantation are summarized and presented
Blood pressure(systolic/diastolic) at each visit
Comparisons between pre-/post- transplantation are summarized and presented.
Pulse rate at each visit
Comparisons between pre-/post- transplantation are summarized and presented.
Rate of normal/abnormal results in Electrocardiogram
Comparisons between pre-/post- transplantation are summarized and presented.
Rate of normal/abnormal results in physical examination at each visit
Comparisons between pre-/post- transplantation are summarized and presented.
Rate of eye infection and inflammation
Eye infection and inflammation test (slit lamp microscopy)
Intraocular pressure test
Intraocular pressure test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04773431
Brief Title
Safety Evaluation of LSCD101 Transplantation for Limbal Stem Cell Deficiency
Official Title
Phase I Study to Evaluate Safety of LSCD101(Cultured Autologous Limbal Epithelial Cell Sheet) Transplantation for Limbal Stem Cell Deficiency
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
January 14, 2021 (Actual)
Study Completion Date
January 14, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CliPS Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Limbus Corneae, Limbus Corneae Insufficiency Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation
Arm Type
Experimental
Arm Description
LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) is transplanted in the lesion.
Intervention Type
Drug
Intervention Name(s)
LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation
Intervention Description
LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) is transplanted in the lesion.
Primary Outcome Measure Information:
Title
Rate of Adverse event
Description
Adverse event
Time Frame
From limbal tissue collection until 24 weeks after transplantation
Secondary Outcome Measure Information:
Title
Rate of normal/abnormal results in clinical laboratory test
Description
Comparisons between pre-/post- transplantation are summarized and presented
Time Frame
Before treatment, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation
Title
Blood pressure(systolic/diastolic) at each visit
Description
Comparisons between pre-/post- transplantation are summarized and presented.
Time Frame
Before treatment, 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation
Title
Pulse rate at each visit
Description
Comparisons between pre-/post- transplantation are summarized and presented.
Time Frame
Before treatment, 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation
Title
Rate of normal/abnormal results in Electrocardiogram
Description
Comparisons between pre-/post- transplantation are summarized and presented.
Time Frame
Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation
Title
Rate of normal/abnormal results in physical examination at each visit
Description
Comparisons between pre-/post- transplantation are summarized and presented.
Time Frame
Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation
Title
Rate of eye infection and inflammation
Description
Eye infection and inflammation test (slit lamp microscopy)
Time Frame
Before treatment, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation
Title
Intraocular pressure test
Description
Intraocular pressure test
Time Frame
Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SoHyang Chung, MD,Ph.D
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
CliPS
City
Seoul
ZIP/Postal Code
04168
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Safety Evaluation of LSCD101 Transplantation for Limbal Stem Cell Deficiency
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