Clinical trial NCT04773431: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Limbus Corneae
Limbus Corneae Insufficiency Syndrome
Lead sponsor: CliPS Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-02-26
Enrollment: 6
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Rate of Adverse event
timeFrame: From limbal tissue collection until 24 weeks after transplantation
Secondary outcomes:
measure: Rate of normal/abnormal results in clinical laboratory test
timeFrame: Before treatment, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation
measure: Blood pressure(systolic/diastolic) at each visit
timeFrame: Before treatment, 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation
measure: Pulse rate at each visit
timeFrame: Before treatment, 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation
measure: Rate of normal/abnormal results in Electrocardiogram
timeFrame: Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation
measure: Rate of normal/abnormal results in physical examination at each visit
timeFrame: Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation
measure: Rate of eye infection and inflammation
timeFrame: Before treatment, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation
measure: Intraocular pressure test
timeFrame: Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: CliPS
Study officials:
affiliation: The Catholic University of Korea
name: SoHyang Chung, MD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: