Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction
This study has been completed.
Sponsor:
Mahidol University
Information provided by (Responsible Party):
Pinnita Prabhasawat, Mahidol University
ClinicalTrials.gov Identifier:
NCT01237600
First received: November 8, 2010
Last updated: December 5, 2011
Last verified: December 2011
| Tracking Information | |||||
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| First Received Date ICMJE | November 8, 2010 | ||||
| Last Updated Date | December 5, 2011 | ||||
| Start Date ICMJE | January 2008 | ||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Ocular surface status (signs of limbal deficiency and immunopathological markers) [ Time Frame: Three years ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01237600 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction | ||||
| Official Title ICMJE | Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction | ||||
| Brief Summary | The purpose of this study is to elucidate the appropriate condition of developing cultivated corneal epithelial graft and evaluate the surgical outcome of transplantation of the cultivated corneal epithelial stem cell in the patients. |
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| Detailed Description | Ocular surface damage caused by severe ocular surface diseases, particularly thermal and chemical burn or Stevens-Johnson syndrome result in corneal epithelial defect, corneal vascularization, corneal conjunctivalization and loss of transparency. Corneal limbal stem cell transplantation has been demonstrated to improve the outcome of ocular surface reconstruction. However, the conventional management of allograft limbal transplantation generally has unsatisfactory outcome because of high risk of rejection and requires long-life immunosuppressive medications. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Cultivated limbal transplantation
Cultivated corneal epithelial stem cell transplantation. Autograft, Living related allograft, and Cadaveric allograft |
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| Study Arm (s) | Experimental: Cultivated limbal transplantation
Intervention: Procedure: Cultivated limbal transplantation |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 19 | ||||
| Completion Date | November 2011 | ||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Thailand | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01237600 | ||||
| Other Study ID Numbers ICMJE | 447/2550(EC2) | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Pinnita Prabhasawat, Mahidol University | ||||
| Study Sponsor ICMJE | Mahidol University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Mahidol University | ||||
| Verification Date | December 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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