Long-term follow-up of the multicenter investigator-initiated clinical trial using cultivated autologous oral mucosal epithelial cell sheet (COMET01) transplantation for patients with limbal stem-cell deficiency

Long-term follow-up of the multicenter investigator-initiated clinical trial using cultivated autologous oral mucosal epithelial cell sheet (COMET01) transplantation for patients with limbal stem-cell deficiency - Long-term follow-up of the multicenter investigator-initiated clinical trial using cultivated autologous oral mucosal epithelial cell sheet (COMET01) transplantation for patients with limbal stem-cell deficiency

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000039992

Enrollment

Registered

2020-03-31

Start date

2016-11-18

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

limbal stem-cell deficiency(LSCD)

Interventions

Observation of efficacy and safety of COMET01 transplant patients after 78 and 104 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients enrolled in the COMET01 study and transplanted with investigational products

Exclusion criteria

Exclusion criteria: 1) Patients planning to participate in other clinical trials during the study participation 2) Patients who desire pregnancy during clinical studies 3) Patients determined to be inappropriate by physicians

Design outcomes

Primary

Measure	Time frame
1) LSCD staging for 104 weeks after COMET01 transplantation	—

Secondary

Measure	Time frame
Efficacy 2) LSCD staging after COMET01 transplantation 3) Subjective symptom 4) Visual acuity 5) QOL 6) Corneal opacity 7) Corneal neovascularization 8) Symblepharon 9) Contributing to the regeneration corneal epithelium in patients with additional therapy 10) LSCD staging, subjective symptom, visual acuity, corneal opacity, corneal neovascularization, and symblepharon of fellow eye * This study makes no distinction between primary and secondary efficacy endpoints Safety 1) Number and rate of adverse events and product-related adverse events 2) Number and rate of significant product-related adverse events	—

Measure

Time frame

Efficacy 2) LSCD staging after COMET01 transplantation 3) Subjective symptom 4) Visual acuity 5) QOL 6) Corneal opacity 7) Corneal neovascularization 8) Symblepharon 9) Contributing to the regeneration corneal epithelium in patients with additional therapy 10) LSCD staging, subjective symptom, visual acuity, corneal opacity, corneal neovascularization, and symblepharon of fellow eye * This study makes no distinction between primary and secondary efficacy endpoints Safety 1) Number and rate of adverse events and product-related adverse events 2) Number and rate of significant product-related adverse events

—

Countries

Japan

Contacts

Public ContactMasami Suzuki

Japan Tissue Engineering Co., Ltd. Clinical Development Dept.

masami_suzuki@jpte.co.jp0533-66-2020

Outcome results

None listed

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