Transplantation of Tissue Cultured Human Amniotic Epithelial Cells Onto Damaged Ocular Surfaces

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00344708
First received: June 23, 2006
Last updated: June 19, 2008
Last verified: June 2008

June 23, 2006
June 19, 2008
September 2000
April 2010   (final data collection date for primary outcome measure)
Ocular surface healing [ Time Frame: 30 days following initiation of treatment ] [ Designated as safety issue: No ]
Ocular surface healing
Complete list of historical versions of study NCT00344708 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Transplantation of Tissue Cultured Human Amniotic Epithelial Cells Onto Damaged Ocular Surfaces
Transplantation of Tissue Cultured Human Amniotic Epithelial Cells Onto Damaged Ocular Surfaces

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Corneal Epithelial Dystrophy
Procedure: Transplantation of Tissue-Cultured Human Amniotic Epithelial Cells
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
April 2010
April 2010   (final data collection date for primary outcome measure)

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.
Female
18 Years to 88 Years
Yes
Contact: Mike Molai, B.S. 214-645-2014 Mike.Molai@UTSouthwestern.edu
United States
 
NCT00344708
0399-090
No
Dr. James P. McCulley/Chairman, Department of Ophthalmology, University of Texas Southwestern Medical Center at Dallas
University of Texas Southwestern Medical Center
Not Provided
Principal Investigator: James P. McCulley, M.D. University of Texas Southwestern Medical Center at Dallas
University of Texas Southwestern Medical Center
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP