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

Corneal Epithelial Dystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00344708
• Other study ID #: 0399-090
• Status: Withdrawn
• Phase: N/A
• Start date: September 2000
• Est. completion date: April 2010

Study information

• Verified date: August 2018
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 88 Years

Eligibility

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.

Related Conditions & MeSH terms

• Corneal Epithelial Dystrophy

Intervention

Procedure:
• Transplantation of Tissue-Cultured Human Amniotic Epithelial Cells

Locations

Country	Name	City	State
United States	Aston Ambulatory Care Center	Dallas	Texas
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular surface healing		30 days following initiation of treatment