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Clinical Trial on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation

Limbal Stem Cell Deficiency Clinical Trial

Official title:
An Investigator-initiated Trial (IIT) on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation in Corneal Limbal Deficiency Patients

Clinical Trial Summary

To investigate the effect of ocular surface reconstruction and assess the safety in cultivated oral mucosal epithelial cell sheet transplantation (COMET) regarding patients with cicatricial change of ocular surface.

Clinical Trial Description

Interventional study for treatment of patients with cicatricial change of ocular surface.

Single Group: (Limbal stem cell deficiency group)

Treatment: After cultivating autologous Oral mucosal epithelial cell sheet, the sheet will be transplanted to the ocular surface of the patients

Inclusion criteria

1. patient with eye which has limbal stem cell deficiency and conjunctivalization of cornea

2. patient who shows no improvement after limbal tissue or amniotic membrane transplantation, or who has difficulty in receiving long-term immunosuppressive treatment

3. patient who agree this clinical trial

4. patient with the eyes in which best corrected visual acuity is less than counting finger

5. patient who is older than sixteen year old

Exclusion criteria

1. patient who has relevant corneal transparency

2. patient who is on the pregnancy or has a plan of pregnancy within 1 year

3. patient who has corneal infection

4. patient who has diagnosis of HBV, HCV, HIV, syphilis

5. patinet who has past medial history of antinal, myocardial infarction, heart failure, arrhythmia, brain stroke, cerebrovascular disease

6. patient who has malignancy

7. patient who shows hypersensitivity to bovine protein.

Primary outcome Epithelization of corneal surface (6 months after cell sheet transplantation)

Secondary outcome Visual acuity (6 months after cell sheet transplantation) ;

Study Design

N/A

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02149732
Study type Expanded Access
Source Seoul National University Hospital
Contact Mee Kum Kim, MD, PhD
Phone 82-10-6277-0798
Email kmk9@snu.ac.kr
Status Available
Phase Phase 1/Phase 2
Start date May 2014
Completion date December 2016
View Details
See also
  Status Clinical Trial Phase
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Completed NCT00736307 - Autologous Transplantation of Cultivated Limbal Stem Cells on Amniotic Membrane in Limbal Stem Cell Deficiency (LSD) Patients Phase 1/Phase 2
Not yet recruiting NCT06412718 - Validation of Human Drugs Target of Repurposed Drugs and Novel Therapies
Recruiting NCT06452316 - Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency Phase 1
Terminated NCT02579993 - ABCB5 as a Prognostic Marker in Survival of Cultivated Limbal Stem Cell Transplantation N/A
Recruiting NCT03943797 - Cultivated Autologous Oral Mucosal Epithelial Transplantation Phase 1
Active, not recruiting NCT03549299 - Allogeneic ABCB5-positive Limbal Stem Cells for Treatment of LSCD Phase 1/Phase 2
Completed NCT03217435 - Corneal Epithelial Allograft From Living-related Donor for LSCD N/A
Recruiting NCT03217487 - Corneal Epithelial Autograft for LSCD N/A
Active, not recruiting NCT00845117 - Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency Phase 1/Phase 2
Enrolling by invitation NCT03015779 - Transplantation of Autologous Oral Mucosal Epithelial Stem Cell Sheet for Treating Limbal Stem Cell Deficiency Disease Phase 1/Phase 2
Active, not recruiting NCT02739113 - Cultivated Autologous Oral Mucosal Epithelial Transplantation for the Treatment of Ocular Surface Diseases Phase 1/Phase 2
Not yet recruiting NCT06265298 - Implementation of a Protocol for the Transdifferentiation of Buccal Mucosal Epithelium Into Corneal Epithelium N/A
Recruiting NCT01756365 - Autologous Cultured Corneal Epithelium (CECA) for the Treatment of Limbal Stem Cell Deficiency N/A
Completed NCT02592330 - Limbal Stem Cell Deficiency (LSCD) Treatment With Cultivated Stem Cell (CALEC) Graft Phase 1/Phase 2
Recruiting NCT02318485 - Limbal Epithelial Stem Cell Transplantation: a Phase II Multicenter Trial Phase 2
Withdrawn NCT01489501 - Multicenter Study of CAOMECS Transplantation to Patients With Total Limbal Stem Cell Deficiency Phase 3