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

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ClinicalTrials.gov Identifier: NCT02149732
Expanded Access Status : Available
First Posted : May 29, 2014
Last Update Posted : April 20, 2016
Sponsor:
Collaborator:
Ministry of Health & Welfare, Korea
Information provided by (Responsible Party):
Seoul National University Hospital

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.

Condition or disease Intervention/treatment
Limbal Stem Cell Deficiency Stevens-johnson Syndrome Ocular Cicatricial Pemphigoid Chemical Burn Biological: cultivated oral mucosal epithelial sheet transplantation

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
Official Title: An Investigator-initiated Trial (IIT) on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation in Corneal Limbal Deficiency Patients
Study Start Date : May 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016



Intervention Details:
  • Biological: cultivated oral mucosal epithelial sheet transplantation
    Autologous cultivated oral mucosal epithelial cell sheet transplantation using oral mucosal adult stem cells in the patients with intractable corneal limbal deficiency

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02149732


Contacts
Contact: Mee Kum Kim, MD, PhD 82-10-6277-0798 kmk9@snu.ac.kr
Contact: Yu Jeong Kim, MD 82-10-2559-1377 21cnasa@naver.com

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Contact: Mee Kum Kim, MD, PhD    82-10-6277-0798    kmk9@snu.ac.kr   
Contact: Dong Hyun Kim, MD    82-10-3737-0975    amidfree@gmail.com   
Principal Investigator: Mee Kum Kim, MD, PhD         
Seoul National Unversity Hospital
Seoul, Korea, Republic of, 110-744
Contact: Mee Kum Kim, MD, PhD    82-10-6277-0798    kmk9@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
Ministry of Health & Welfare, Korea
Investigators
Principal Investigator: Mee Kum Kim, MD, PhD Department of Ophthalmology, Seoul National University College of Medicine

Publications:
Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02149732     History of Changes
Other Study ID Numbers: COMET trial
MKKim ( Other Grant/Funding Number: Ministry of Health & Welfare, Republic of Korea (HI11C1590) )
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016

Keywords provided by Seoul National University Hospital:
Limbal stem cell deficiency
Cultivated oral mucosal cell sheet transplantation
Ocular surface reconstruction

Additional relevant MeSH terms:
Pemphigoid, Bullous
Pemphigoid, Benign Mucous Membrane
Stevens-Johnson Syndrome
Burns, Chemical
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Stomatitis
Mouth Diseases
Stomatognathic Diseases
Drug Eruptions
Dermatitis
Erythema Multiforme
Erythema
Drug Hypersensitivity
Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Burns
Wounds and Injuries
Conjunctival Diseases
Eye Diseases