Safety Evaluation of LSCD101 Transplantation for Limbal Stem Cell Deficiency

CliPS Co., Ltd

Status and phase

Completed

Phase 1

Conditions

Limbus Corneae Insufficiency Syndrome

Limbus Corneae

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT04773431

LSCD101_P1

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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