Corneal epithelial stem cell deficiency Corneal epithelial stem cell deficiency
Conditions
Interventions
Cut out the uninjured part (about 2 mm x 5 mm) of the patient's conjunctival tissue in the ophthalmology surgery room of Itabashi Hospital, Nihon University School of Medicine. Transport the excised c
Sponsors
Yamagami Satoru
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Target Disease Patients with Corneal Epithelial Stem Cell Deficiency Syndrome Inclusion Criteria Patients who meet all of the following criteria are eligible: 1) Patients with Stage III corneal epithelial stem cell depletion syndrome (LSCD) as defined by the Working Group for the Development of Standards for the Use of Human (Autologous) Oral Mucosa-Derived Epithelial Cell Sheets of the Japanese Ophthalmological Society and the Japanese Corneal Transplant Society. 2) Men and women aged 20 years or older at the time of consent 3) Patients who have provided written informed consent
Exclusion criteria
Exclusion criteria: Exclusion Criteria Patients who meet any of the following criteria will not be enrolled in this study: 1) Pregnant or potentially pregnant patients, and breastfeeding patients. 2) Patients with infectious diseases (HBV, HCV, HIV, HTLV-1). 3) Patients with aqueous lacrimation (Schirmer test: 1 mm or less). 4) Patients who have undergone the following surgery on the recipient eye within the last 6 months: - Conjunctival sac formation - Amniotic membrane transplantation onto the sclera - Mitomycin treatment 5) Patients with obvious scarring or signs of inflammation at the harvest site, making harvesting impossible. 6) Patients who the attending physician deems inappropriate for participation due to other complications, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After the postoperative observation period of 3 months, the safety will be evaluated. Presence or absence of transplanted cell sheet shedding, evaluation of predicted ocular complications, Evaluate all adverse events, including abnormal changes in laboratory test values. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of effectiveness 1) Judgment of the condition of the eye surface 2) Visual acuity (corrected visual acuity) 3) Corneal opacity 4) Corneal neovascularization | — |
Countries
Japan
Contacts
Public ContactSeiichi Yokoo
The University of Tokyo Hospital
Outcome results
None listed