Safety Evaluation of LSCD101 Transplantation for Limbal Stem Cell Deficiency

Phase 1

Completed

• Conditions: Limbus Corneae; Limbus Corneae Insufficiency Syndrome
• Interventions: Drug: LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation

• Registration Number: NCT04773431
• Lead Sponsor: CliPS Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-31
• Status Verified: 2021-01
• Primary Completion: 2021-01-14
• Study Completion: 2021-01-14
• Study First Submitted: 2021-01-22
• Study First Submitted QC: 2021-02-24
• Last Update Submitted: 2021-02-24
• Study First Posted: 2021-02-26
• Last Update Posted: 2021-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation	LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation	LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) is transplanted in the lesion.

Primary Outcome Measures

Name	Time	Method
Rate of Adverse event	From limbal tissue collection until 24 weeks after transplantation	Adverse event

Secondary Outcome Measures

Name	Time	Method
Rate of normal/abnormal results in clinical laboratory test	Before treatment, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation	Comparisons between pre-/post- transplantation are summarized and presented
Blood pressure(systolic/diastolic) at each visit	Before treatment, 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation	Comparisons between pre-/post- transplantation are summarized and presented.
Pulse rate at each visit	Before treatment, 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation	Comparisons between pre-/post- transplantation are summarized and presented.
Rate of normal/abnormal results in Electrocardiogram	Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation	Comparisons between pre-/post- transplantation are summarized and presented.
Rate of normal/abnormal results in physical examination at each visit	Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation	Comparisons between pre-/post- transplantation are summarized and presented.
Rate of eye infection and inflammation	Before treatment, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation	Eye infection and inflammation test (slit lamp microscopy)
Intraocular pressure test	Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation	Intraocular pressure test

Trial Locations

Locations (1)

CliPS; 🇰🇷 Seoul, Korea, Republic of