臨床研究等提出・公開システム

Date of registration	April. 27, 2026
Last modified on	Sept. 07, 2026
Trial ID	jRCT2053260029

Scientific Title	A single-arm, unblinded phase 2 trial of allogeneic iPS cell-derived corneal epithelial cell sheet REM-01 transplantation in subjects with limbal stem cell deficiency
Public Title	A single-arm, unblinded phase 2 trial of allogeneic iPS cell-derived corneal epithelial cell sheet REM-01 transplantation in subjects with limbal stem cell deficiency

Contact for Scientific Queries	Name	Hiramine Yasushi
	Affiliation	RAYMEI Inc.
	Address	#D95 Industry-University Co-Creation(Bldg. D) 2-1 Yamada-oka Suita, Osaka
	Telephone	+81-647985260
	E-mail	yasushi.hiramine@raymei.co.jp
Contact for Public Queries	Name	Hiramine Yasushi
	Affiliation	RAYMEI Inc.
	Address	#D95 Industry-University Co-Creation(Bldg. D) 2-1 Yamada-oka Suita, Osaka
	Telephone	+81-647985260
	E-mail	yasushi.hiramine@raymei.co.jp

Recruitment status	Recruiting


Anticipated date of first enrollment		April. 10, 2026
Actual date of first enrollment		May. 22, 2026
Target sample size		12
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients diagnosed with Stage IIB, IIC, or III of linbal stem cell deficiency according to the severity classification. 2) Patients who have provided written consent to participate in this clinical trial, either by themselves or their legal representative. 3) Patients aged 16 years or older at the time of obtaining consent.
	Exclusion Criteria	1) Patients with contraindications to the antibacterial agents, steroids, immunosuppressants, or anesthetics used in this clinical trial. 2) Patients with a history of allergy to cattle, mice, or pigs. 3) Patients with a history of malignant tumors within the past 5 years, or patients suspected of having malignant tumors. 4) Patients with glaucoma whose intraocular pressure is poorly controlled. 5) Patients with diabetes whose blood glucose is poorly controlled. 6) Pregnant women, breastfeeding women, patients who may be pregnant, or patients who wish to become pregnant during the clinical trial period. 7) Patients who have participated in, are currently participating in, or are scheduled to participate in clinical trials of other pharmaceuticals, regenerative medicine products, or medical devices within 16 weeks prior to the scheduled transplant. 8) Patients scheduled to undergo intraocular surgery during the clinical trial period. 9) Patients who have complications, infections, etc. in the transplanted eye or systemically, and who the principal investigator or co-investigator determines cannot be adequately evaluated (patients who are positive for HBs antigen, HBc antibody, or HBs antibody are considered unsuitable. However, this does not apply to hepatitis B vaccine recipients who are positive for HBs antibody, negative for HBs antigen, and negative for HBc antibody). 10) Other patients whom the principal investigator or co-investigator deems unsuitable.
	Age Minimum	16age old over
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		Limbal stem cell deficiency
Intervention(s)		For each eye, an iPS cell-derived corneal epithelial cell sheet is transplanted onto the corneal surface
Health Condition(s) Code		D000092423
Primary Outcome(s)		Success rate of corneal epithelial reconstruction at 52 weeks after REM-01 transplantation (%)
Secondary Outcome(s)		Efficacy 1) Severity of limbal stem cell deficiency up to 52 weeks post-REM-01 transplantation 2) Corrected visual acuity up to 52 weeks post-REM-01 transplantation 3) Severity of corneal opacity up to 52 weeks post-REM-01 transplantation 4) Severity of corneal neovascularization up to 52 weeks post-REM-01 transplantation 5) Severity of symblepharon up to 52 weeks post-REM-01 transplantation 6) Corneal epithelial defects up to 52 weeks post-REM-01 transplantation Safety 1) Key safety endpoints: rejection, neoplastic lesions 2) Frequency and severity of adverse events 3) Frequency of complications

Primary Sponsor	RAYMEI Inc.

Secondary Sponsor

Name of Certified Review Board	Institutional Review Board of University of Osaka Hospital
Address	2-2 Yamadaoka, Suita City, Osaka
Approval Status	Approval
Date of approval	April. 10, 2026

Name of Certified Review Board	Institutional Review Board of Tokyo Dental College Ichikawa General Hospital
Address	5-11-13 Sugano, Ichikawa City, Osaka
Approval Status	Approval
Date of approval	April. 10, 2026

Name of Certified Review Board	Institutional Review Board of Toho University Omori Medical Center
Address	6-11-1 Omori-Nishi, Ota-ku, Osaka
Approval Status	Not approval
Date of approval	April. 10, 2026

Name of Certified Review Board	Institutional Review Board of University of Tokyo hospital
Address	7-3-1 Hongo, Bunkyo-ku, Osaka
Approval Status	Approval
Date of approval	April. 10, 2026

Name of Certified Review Board	Institutional Review Board of National Center for Geriatrics and Gerontology
Address	7-430 Morioka-cho, Obu City, Osaka
Approval Status	Approval
Date of approval	April. 10, 2026

Name of Certified Review Board	Institutional Review Board of SUGITA EYE HOSPITAL
Address	5-1-30 Sakae, Naka-ku, Nagoya City, Osaka
Approval Status	Approval
Date of approval	April. 10, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Sept. 07, 2026	(this page)	Changes
1	April. 27, 2026	Detail

List of change history