Transplantation of Tissue Cultured Human Amniotic Epithelial Cells Onto Damaged Ocular Surfaces
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | June 23, 2006 | ||||
| Last Updated Date | June 19, 2008 | ||||
| Start Date ICMJE | September 2000 | ||||
| Estimated Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Ocular surface healing [ Time Frame: 30 days following initiation of treatment ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Ocular surface healing | ||||
| Change History | Complete list of historical versions of study NCT00344708 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 | Transplantation of Tissue Cultured Human Amniotic Epithelial Cells Onto Damaged Ocular Surfaces | ||||
| Official Title ICMJE | Transplantation of Tissue Cultured Human Amniotic Epithelial Cells Onto Damaged Ocular Surfaces | ||||
| Brief Summary | To investigate the effect of using tissue cultured human amniotic epithelial cells to re-establish severely damaged ocular surfaces. Specifically, to determine the efficacy of transplanted tissue cultured amniotic epithelial cells on persistent corneal epithelial defect, a potential visual threaten ocular disorder. |
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| Detailed Description | Ocular surface diseases and injury caused by chemicals, result in chronic ulceration, and may never be able to be healed normally, and may lead to permanent vision loss. Standard medical treatments often fail. Histologically and somehow functionally, human amniotic cells are similar to ocular surface cells, and these cells have been shown to be safe to be transplanted to another subject and will not be rejected by the recipient. In animal studies, amniotic cells demonstrated that they can re-establish the integrity of ocular surface in more than 30% of recipients without apparent toxic side effects. This study will investigate this novel strategy for its effect on human ocular surface disorder. It will provide a potential alternative therapy for this difficult and devastating disease. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Corneal Epithelial Dystrophy | ||||
| Intervention ICMJE | Procedure: Transplantation of Tissue-Cultured Human Amniotic Epithelial Cells | ||||
| Study Arm (s) | Not Provided | ||||
| 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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | April 2010 | ||||
| Estimated Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 88 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00344708 | ||||
| Other Study ID Numbers ICMJE | 0399-090 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. James P. McCulley/Chairman, Department of Ophthalmology, University of Texas Southwestern Medical Center at Dallas | ||||
| Study Sponsor ICMJE | University of Texas Southwestern Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Texas Southwestern Medical Center | ||||
| Verification Date | June 2008 | ||||
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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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