JPRN-UMIN000018662Completed未知
Multicenter Investigator-initiated clinical trial using cultivated autologous oral mucosal epithelial cell sheet (COMET01) transplantation for patients with limbal stem-cell deficiency - Multicenter Investigator-initiated clinical trial using COMET01 for patients with limbal stem-cell deficiency
Department of Ophthalmology, Osaka University Graduate School of Medicine0 sites6 target enrollmentStarted: August 13, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 6
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1) contraindication to antimicrobials, steroid drugs, and anesthetics used in the trial 2) allergy to antibiotics of penicillin, kanamycin, streptomycin, amphotericin B; Medical history of allergy to penicillin antibiotic and aminoglycoside antibiotic 3) medical history of allergy to animal (cattle, mice, or pigs) 4) malignant tumor within 5 years before registration, or doubtful malignant tumor 5) glaucoma with uncontrollable IOP 6) diabetes with uncontrollable glycemic control 7) eye with central visual field defect 8) extremely severe dry eye 9) planned intraocular surgery during the trial 10) eye with severe eyelid defect 11) systemic complications unsuitable for entry in this trial 12) pregnant/lactating women, might be pregnant women; wish to become pregnant women 13) another trial participant within 16 weeks before COMET01 transplantation, planning to participate in another trial during this trial 14) unsuitable for entry in this trial judged by principal investigator or sub-investigators
Investigators
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