Safety Evaluation of LSCD101 Transplantation for Limbal Stem Cell Deficiency (NCT04773431) | Clinical Trial Compass
CompletedPhase 1
Safety Evaluation of LSCD101 Transplantation for Limbal Stem Cell Deficiency
South Korea6 participantsStarted 2020-01-31
Plain-language 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.
Who can participate
Age range19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, HTLVâ… /â…ˇ, 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 childbeari…
What they're measuring
1
Rate of Adverse event
Timeframe: From limbal tissue collection until 24 weeks after transplantation