The exploratory safety study of adipose-derived mesenchymal stem cells for non-infectious corneal ulcers

The exploratory safety study of adipose-derived mesenchymal stem cells for idiopathic periperal corneal ulcer and cGVHD related corneal ulcer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTa030220167

Enrollment

Registered

2022-06-27

Start date

2022-06-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic peripheral ulcer and cGVHD related corneal ulcer Idiopathic peripheral ulcer, cGVHD related corneal ulcer

Interventions

Subconjunctival injection of 2 x 10^7 human adipose-derived mesenchymal stem cells in 0.5 mL Ringer's solution

Subconjunctival injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Informed consent of this study 2) Over 20 years old 3) Red eye with pain or photophobia 4) Unilateral non-infectious corneal ulcer (idiopathic peripheral ulcer or cGVHD relatedcorneal ulcer) refractive to anti-inflammatory drugs (steroids and immunosuppressants) Idiopathic peripheral corneal ulcer area should be over one quadrant and less than two qu adrants.

Exclusion criteria

Exclusion criteria: 1) Rheumatic ulcerative keratitis 2) Staphylococcal ulcerative keratitis 3) Ulcerative keratitis due to rabbit eye and bulging eye 4) Terrien corneal degeneration 5) Scleral inflammation 6) Significant systemic complications of heart, kidney or respiratory tract 7) 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 8) Malignant neoplasm 9) History of venous thrombosis or pulmonary embolism 10) 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 11) Bilateral corneal ulcers 12) Patients with uncontrolled diabetes 13) Patients who are scheduled for ocular surgical treatment during this clinical study 14) Patients with a history of drug allergy for penicillin or aminoglycoside 15) 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 sign and clinical examination	—

Secondary

Measure	Time frame
Efficacy: Clinical signs following subconjunctival injection of human adiposederived mesenchymal stem cells, ulcer area, improvement in corneal thickness by OCT. Visual acuity and intra ocular pressure	—

Countries

Japan

Contacts

Public ContactNoriko Miichi

Keio University

nmiichi@keio.jp+81-3-3353-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026