Transplantation of Tissue Cultured Human Amniotic Epithelial Cells Onto Damaged Ocular Surfaces
Recruitment status was Recruiting
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Purpose
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 |
|---|---|
|
Corneal Epithelial Dystrophy |
Procedure: Transplantation of Tissue-Cultured Human Amniotic Epithelial Cells |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Transplantation of Tissue Cultured Human Amniotic Epithelial Cells Onto Damaged Ocular Surfaces |
- Ocular surface healing [ Time Frame: 30 days following initiation of treatment ] [ Designated as safety issue: No ]
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 88 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Patients with corneal epithelial defects and ulcers that have persisted for 4 weeks or longer, regardless of their cause. These patients will have received traditional medical therapy, including correcting the underlying causes, suppressing inflammation, and augmenting the tissue healing processes, but the epithelial defects have persisted.
Exclusion Criteria:
- Patients who are pregnant or under age 18 will be excluded.
Placentas will not be used if the following problems are present:
- If the mother has an infection at the time of her baby's birth;
- If the mother has a high risk of developing infection due to intravenous drug use or other factors;
- If the mother has diabetes, arthritis, or raised blood pressure;
- If the baby is unhealthy;
- If there is evidence of infection of the womb (uterus) and afterbirth (placenta) at the time of delivery.
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Dr. James P. McCulley/Chairman, Department of Ophthalmology, University of Texas Southwestern Medical Center at Dallas |
| ClinicalTrials.gov Identifier: | NCT00344708 History of Changes |
| Other Study ID Numbers: | 0399-090 |
| Study First Received: | June 23, 2006 |
| Last Updated: | June 19, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Texas Southwestern Medical Center:
|
Tissue-Cultured Human Amniotic Epithelial Cells onto damaged corneal surface |
Additional relevant MeSH terms:
|
Cogan Syndrome Vestibulocochlear Nerve Diseases Cranial Nerve Diseases Nervous System Diseases |
Eye Diseases Vasculitis Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013