Safety Evaluation of LSCD101 Transplantation for Limbal Stem Cell Deficiency
NCT ID: NCT04773431
Last Updated: 2021-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
6 participants
INTERVENTIONAL
2020-01-31
2021-01-14
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation
LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) is transplanted in the lesion.
LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation
LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) is transplanted in the lesion.
Interventions
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LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation
LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) is transplanted in the lesion.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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CliPS Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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SoHyang Chung, MD,Ph.D
Role: PRINCIPAL_INVESTIGATOR
The Catholic University of Korea
Locations
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CliPS
Seoul, , South Korea
Countries
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Other Identifiers
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LSCD101_P1
Identifier Type: -
Identifier Source: org_study_id