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

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Brief Title

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

Official Title

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

Brief 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.
    

Detailed 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 Type

Expanded Access




Condition

Limbal Stem Cell Deficiency

Intervention

cultivated oral mucosal epithelial sheet transplantation


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological


Start Date

May 2014

Completion Date

December 2016

Primary Completion Date

December 2016

Eligibility Criteria

        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.
      

Gender

All

Ages

16 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Mee Kum Kim, MD, PhD, 82-10-6277-0798, [email protected]

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT02149732

Organization ID

COMET trial

Secondary IDs

MKKim

Responsible Party

Sponsor

Study Sponsor

Seoul National University Hospital

Collaborators

 Ministry of Health & Welfare, Korea

Study Sponsor

Mee Kum Kim, MD, PhD, Principal Investigator, Department of Ophthalmology, Seoul National University College of Medicine


Verification Date

April 2016