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Transplantation of Autologous Oral Mucosal Epithelial Sheets for Limbal Stem-cell Deficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02415218
Recruitment Status : Completed
First Posted : April 14, 2015
Last Update Posted : October 11, 2019
Sponsor:
Collaborator:
Osaka University
Information provided by (Responsible Party):
Adisak Wongkajornsilp, Siriraj Hospital

Tracking Information
First Submitted Date  ICMJE April 8, 2015
First Posted Date  ICMJE April 14, 2015
Last Update Posted Date October 11, 2019
Study Start Date  ICMJE April 17, 2013
Actual Primary Completion Date September 3, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2015)
Evaluation of conjunctivalization and corneal epithelial defect [ Time Frame: 1 year after transplantation ]
One year after the transplantation, an area of no conjunctivalization and no corneal epithelial defect will be rated according to the Grading scale described in Table 2, on the basis of which the efficacy of the investigational therapy will be assessed. Generally, the preoperative condition of ocular surface is rated as "Bad (Grading 0)." In subjects showing improvement to Grading 2 or greater, the investigational therapy will be assessed as effective.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2015)
Corrected visual acuity (efficacy) [ Time Frame: 1 year ]
Corrected visual acuity will be evaluated by the decimal acuity method and converted to Log MAR values, which will be used to assess the extent of postoperative change in visual acuity. Note that 0.005 will be given to "counting fingers," 0.002, to "hand motion," and 0.001, to "light perception" 14). Visual acuity will be measured before transplantation, and 1, 3, and 6 months as well as one year after transplantation.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transplantation of Autologous Oral Mucosal Epithelial Sheets for Limbal Stem-cell Deficiency
Official Title  ICMJE Clinical Study of Transplantation of Autologous Cultivated Oral Mucosal Epithelial Sheets for Limbal Stem-cell Deficiency
Brief Summary The study purpose is to evaluate the efficacy and safety of cultivated oral mucosal epithelial sheet transplantation as a novel therapy for limbal stem cell deficiency, for which no effective approaches has thus far been available, for the purpose of establishing this therapy as an effective strategy for this disease with an aim of improving visual acuity and corneal transparency.
Detailed Description The efficacy and safety of cultivated oral mucosal epithelial sheet transplantation as a novel therapy for limbal stem-cell deficiency, for which no effective approaches have thus far been available, will be evaluated for the purpose of establishing this therapy as an effective strategy for this disease with an aim of improving visual acuity and corneal transparency. The primary endpoint will be an area of no conjunctivalization and no corneal epithelial defect at one year, which will be evaluated according to a 6-grade rating scale. The secondary endpoints will be corrected visual acuity, severity of corneal opacification, extent of corneal neovascularization, expected ocular complications, and all adverse events including abnormal laboratory findings. The purpose of this research is to evaluate the efficacy of the investigational therapy so as to provide rationales for making this strategy approved as an advanced medical care in the future.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Limbal Stem-cell Deficiency
Intervention  ICMJE Biological: Mucosal cell sheet transplantation
The subjects will have their oral mucosal tissues retrieved for cell sheet preparation. The mucosal cell sheet will be transplanted over the affected cornea.
Study Arms  ICMJE Experimental: Mucosal cell sheet transplantation
The subjects will have their oral mucosal tissues retrieved for cell sheet preparation. The mucosal cell sheet will be transplanted over the affected cornea.
Intervention: Biological: Mucosal cell sheet transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 8, 2019)
6
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2015)
12
Actual Study Completion Date  ICMJE April 16, 2017
Actual Primary Completion Date September 3, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Among patients with bilateral limbal stem-cell deficiency, those who meet all the criteria listed below when they give their informed consent to participate in this research will be included.

    1. Patients in whom the eye(s) (subject to the interventional therapy) show(s) loss or dysfunction of corneal epithelial stem cells throughout the total* circumference of the cornea
    2. Patients in whom the corneal surface of the eye(s) (subject to the investigational therapy) is(are) entirely enveloped by conjunctival tissue
    3. Patients of both genders aged ≥20 years when they give their informed consent
    4. Patients who have given their own written consent to participate in this clinical research (The target disease is bilateral limbal stem-cell deficiency, although it is not always necessary that the both eyes of the patient meet the inclusion criteria.)

Exclusion Criteria:

  1. Patients who are or may be pregnant, and patients who are breast feeding
  2. Patients with infections (HBV, HCV, HIV, HTLV-1)
  3. Patients with extreme hypolacrimation resistant to therapy
  4. Patients from whom oral mucosal specimens cannot be collected because clear scar formation or inflammatory findings are noted in a cell-collection site of the mucosal membrane
  5. Patients whose score of Performance Status (PS*) is 3 or more
  6. Any others who are judged by the chief subinvestigator to be ineligible for this clinical research, due to the presence of complications, etc.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02415218
Other Study ID Numbers  ICMJE 662/2555(EC2)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Adisak Wongkajornsilp, Siriraj Hospital
Study Sponsor  ICMJE Siriraj Hospital
Collaborators  ICMJE Osaka University
Investigators  ICMJE
Principal Investigator: Adisak Wongkajornsilp, M.D., Ph.D. Mahidol University
PRS Account Siriraj Hospital
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP