Not provided
Not provided
Not provided
Not provided
Not provided
Potential subjects did not meet eligibility criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transplantation of Tissue-Cultured Human Amniotic Epithelial Cells | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular surface healing | 30 days following initiation of treatment |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients who are pregnant or under age 18 will be excluded.
Placentas will not be used if the following problems are present:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James P. McCulley, M.D. | University of Texas, Southwestern Medical Center at Dallas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aston Ambulatory Care Center | Dallas | Texas | 75390-8866 | United States | ||
| University of Texas Southwestern Medical Center at Dallas |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dallas |
| Texas |
| 75390-8866 |
| United States |