Clinical trial NCT00344708: Transplantation of Tissue Cultured Human Amniotic Epithelial Cells Onto Damaged Ocular Surfaces
Official title: Transplantation of Tissue Cultured Human Amniotic Epithelial Cells Onto Damaged Ocular Surfaces
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Corneal Epithelial Dystrophy
Keywords: Tissue-Cultured Human Amniotic Epithelial Cells onto damaged corneal surface
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2006-06-27
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Ocular surface healing
timeFrame: 30 days following initiation of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Aston Ambulatory Care Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
Study officials:
affiliation: University of Texas, Southwestern Medical Center at Dallas
name: James P. McCulley, M.D.
role: PRINCIPAL_INVESTIGATOR
References: