Non-infectious corneal ulcer Non-infectious corneal ulcer
Conditions
Interventions
Subconjunctival injection (one spot) of 2x10^6 human adipose-derived mesenchymal stem cells in 0.25 mL Ringer's solution
Sponsors
Shimmura Shigeto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients for whom written consent has been obtained based on their own free will regarding participation in this study 2) Individuals aged 20 or older at the time of consent acquisition 3) Patients presenting with eye pain accompanied by redness, tearing, and photophobia 4) Patients with non-infectious corneal ulcers who showed progression of the ulcer despite response to local and systemic medical anti-inflammatory therapy (steroids and immunosuppressants)
Exclusion criteria
Exclusion criteria: 1) Infectious keratitis 2) Ulcerative keratitis due to lagophthalmos and proptosis 3) Terrien corneal degeneration 4) Scleral inflammation 5) Significant systemic complications of heart, kidney or respiratory tract 6) Female patients who are or plan to become pregnant during the course of the study, and male patients who wish to have their partners become pregnant during the course of the study 7) History of venous thrombosis or pulmonary embolism 8) Participants who were enrolled in another clinical study or clinical trial within 3 months prior to the study, or plan to enroll during the course of this study 9) Patients with uncontrolled diabetes 10) Patients who need ocular surgical treatment due to the perforation or similar conditions 11) Other potential participants deemed to be inappropriate by physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Side effects of sub-conjunctival injection of human adipose-derived mesenchymal stem cells (systemic side-effects, pain, edema), vital signs, and clinical examination | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Clinical signs following subconjunctival injection of human adipose-derived mesenchymal stem cells, ulcer area, improvement in corneal thickness by OCT, visual acuity and intra ocular pressure | — |
Countries
Japan
Contacts
Public ContactMieko Saiki
Fujita Academy, Fujita Medical Innovation Center Tokyo, Fujita Health University School of Medicine
Outcome results
None listed