Safety Evaluation of LSCD101 Transplantation for Limbal Stem Cell Deficiency

Limbus Corneae Clinical Trial

Official title:

Phase I Study to Evaluate Safety of LSCD101(Cultured Autologous Limbal Epithelial Cell Sheet) Transplantation for Limbal Stem Cell Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04773431
• Other study ID #: LSCD101_P1
• Status: Completed
• Phase: Phase 1
• Start date: January 31, 2020
• Est. completion date: January 14, 2021

Study information

• Verified date: January 2021
• Source: CliPS Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 14, 2021
• Est. primary completion date: January 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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, HTLV?/?, 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

Related Conditions & MeSH terms

• Corneal Diseases
• Limbus Corneae
• Limbus Corneae Insufficiency Syndrome

Intervention

Drug:
• LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation
LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) is transplanted in the lesion.

Locations

Country	Name	City	State
Korea, Republic of	CliPS	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CliPS Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Adverse event	Adverse event	From limbal tissue collection until 24 weeks after transplantation
Secondary	Rate of normal/abnormal results in clinical laboratory test	Comparisons between pre-/post- transplantation are summarized and presented	Before treatment, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation
Secondary	Blood pressure(systolic/diastolic) at each visit	Comparisons between pre-/post- transplantation are summarized and presented.	Before treatment, 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation
Secondary	Pulse rate at each visit	Comparisons between pre-/post- transplantation are summarized and presented.	Before treatment, 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation
Secondary	Rate of normal/abnormal results in Electrocardiogram	Comparisons between pre-/post- transplantation are summarized and presented.	Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation
Secondary	Rate of normal/abnormal results in physical examination at each visit	Comparisons between pre-/post- transplantation are summarized and presented.	Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation
Secondary	Rate of eye infection and inflammation	Eye infection and inflammation test (slit lamp microscopy)	Before treatment, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation
Secondary	Intraocular pressure test	Intraocular pressure test	Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation