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
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 September 30, 2014