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Sponsored by: |
University of Texas Southwestern Medical Center |
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Information provided by: | University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT00344708 |
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.
Condition | Intervention |
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Corneal Epithelial Dystrophy |
Procedure: Transplantation of Tissue-Cultured Human Amniotic Epithelial Cells |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Transplantation of Tissue Cultured Human Amniotic Epithelial Cells Onto Damaged Ocular Surfaces |
Estimated Enrollment: | 20 |
Study Start Date: | September 2000 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 88 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Placentas will not be used if the following problems are present:
Contact: Mike Molai, B.S. | 214-645-2014 | Mike.Molai@UTSouthwestern.edu |
United States, Texas | |
University of Texas Southwestern Medical Center at Dallas | Recruiting |
Dallas, Texas, United States, 75390-8866 | |
Contact: Mike Molai, B.S. 214-645-2014 Mike.Molai@UTSouthwestern.edu | |
Sub-Investigator: Pawan Prasher, M.D. | |
Sub-Investigator: James P McCulley | |
Aston Ambulatory Care Center | Recruiting |
Dallas, Texas, United States, 75390-8866 | |
Contact: Mike Molai, B.S. 214-645-2014 Mike.Molai@UTSouthwestern.edu |
Principal Investigator: | James P. McCulley, M.D. | University of Texas Southwestern Medical Center at Dallas |
Responsible Party: | University of Texas Southwestern Medical Center at Dallas ( Dr. James P. McCulley/Chairman, Department of Ophthalmology ) |
Study ID Numbers: | 0399-090 |
Study First Received: | June 23, 2006 |
Last Updated: | June 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00344708 |
Health Authority: | United States: Institutional Review Board |
Tissue-Cultured Human Amniotic Epithelial Cells onto damaged corneal surface |
Corneal dystrophy, epithelial basement membrane |