Transplantation of Tissue Cultured Human Amniotic Epithelial Cells Onto Damaged Ocular Surfaces - Full Text View

Sponsored by:	University of Texas Southwestern Medical Center
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00344708

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

U.S. FDA Resources

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

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:

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)

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.

Eligibility

Ages Eligible for Study:	18 Years to 88 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344708

Contacts

Contact: Mike Molai, B.S.

214-645-2014

Mike.Molai@UTSouthwestern.edu

Locations

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

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

Principal Investigator:

James P. McCulley, M.D.

University of Texas Southwestern Medical Center at Dallas

More Information

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

Keywords provided by University of Texas Southwestern Medical Center:

Tissue-Cultured Human Amniotic Epithelial Cells onto damaged corneal surface

Study placed in the following topic categories:

Corneal dystrophy, epithelial basement membrane

ClinicalTrials.gov processed this record on January 13, 2009