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

Primary Purpose

Limbal Stem Cell Deficiency, Stevens-johnson Syndrome, Ocular Cicatricial Pemphigoid

Status
Available
Phase
Locations
Korea, Republic of
Study Type
Expanded Access
Intervention
cultivated oral mucosal epithelial sheet transplantation
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Limbal Stem Cell Deficiency focused on measuring Limbal stem cell deficiency, Cultivated oral mucosal cell sheet transplantation, Ocular surface reconstruction

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seoul National University Hospital
  • Seoul National Unversity Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 14, 2014
Last Updated
April 18, 2016
Sponsor
Seoul National University Hospital
Collaborators
Ministry of Health & Welfare, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT02149732
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
Study Type
Expanded Access

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Available
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
Ministry of Health & Welfare, Korea

4. Oversight

5. Study Description

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 patient with eye which has limbal stem cell deficiency and conjunctivalization of cornea patient who shows no improvement after limbal tissue or amniotic membrane transplantation, or who has difficulty in receiving long-term immunosuppressive treatment patient who agree this clinical trial patient with the eyes in which best corrected visual acuity is less than counting finger patient who is older than sixteen year old Exclusion criteria patient who has relevant corneal transparency patient who is on the pregnancy or has a plan of pregnancy within 1 year patient who has corneal infection patient who has diagnosis of HBV, HCV, HIV, syphilis patinet who has past medial history of antinal, myocardial infarction, heart failure, arrhythmia, brain stroke, cerebrovascular disease patient who has malignancy 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Limbal Stem Cell Deficiency, Stevens-johnson Syndrome, Ocular Cicatricial Pemphigoid, Chemical Burn
Keywords
Limbal stem cell deficiency, Cultivated oral mucosal cell sheet transplantation, Ocular surface reconstruction

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
cultivated oral mucosal epithelial sheet transplantation
Intervention Description
Autologous cultivated oral mucosal epithelial cell sheet transplantation using oral mucosal adult stem cells in the patients with intractable corneal limbal deficiency

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient with eye which has limbal stem cell deficiency and conjunctivalization of cornea patient who shows no improvement after limbal tissue or amniotic membrane transplantation, or who has difficulty in receiving long-term immunosuppressive treatment patient who agree this clinical trial patient with the eyes in which best corrected visual acuity is less than counting finger patient who is older than sixteen year old Exclusion Criteria: patient who has relevant corneal transparency patient who is on the pregnancy or has a plan of pregnancy within 1 year patient who has corneal infection patient who has diagnosis of HBV, HCV, HIV, syphilis patinet who has past medial history of antinal, myocardial infarction, heart failure, arrhythmia, brain stroke, cerebrovascular disease patient who has malignancy patient who shows hypersensitivity to bovine protein.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mee Kum Kim, MD, PhD
Phone
82-10-6277-0798
Email
kmk9@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Jeong Kim, MD
Phone
82-10-2559-1377
Email
21cnasa@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mee Kum Kim, MD, PhD
Organizational Affiliation
Department of Ophthalmology, Seoul National University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mee Kum Kim, MD, PhD
Phone
82-10-6277-0798
Email
kmk9@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Dong Hyun Kim, MD
Phone
82-10-3737-0975
Email
amidfree@gmail.com
First Name & Middle Initial & Last Name & Degree
Mee Kum Kim, MD, PhD
Facility Name
Seoul National Unversity Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mee Kum Kim, MD, PhD
Phone
82-10-6277-0798
Email
kmk9@snu.ac.kr

12. IPD Sharing Statement

Citations:
PubMed Identifier
15371576
Citation
Nishida K, Yamato M, Hayashida Y, Watanabe K, Yamamoto K, Adachi E, Nagai S, Kikuchi A, Maeda N, Watanabe H, Okano T, Tano Y. Corneal reconstruction with tissue-engineered cell sheets composed of autologous oral mucosal epithelium. N Engl J Med. 2004 Sep 16;351(12):1187-96. doi: 10.1056/NEJMoa040455.
Results Reference
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Clinical Trial on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation

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