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WithdrawnNCT00344708Updated Aug 22, 2018

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

An interventional study of Transplantation of Tissue-Cultured Human Amniotic Epithelial Cells in Corneal Epithelial Dystrophy, sponsored by University of Texas Southwestern Medical Center. Withdrawn at 2 sites in United States. Open to female participants aged 18 Years to 88 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-22.

Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Potential subjects did not meet eligibility criteria
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 88 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Corneal Epithelial Dystrophy

Keywords

  • Tissue-Cultured Human Amniotic Epithelial Cells onto damaged corneal surface
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In context

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 88 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Interventions

  • ProcedureTransplantation of Tissue-Cultured Human Amniotic Epithelial Cells
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What researchers measure

Primary outcomes

  1. Ocular surface healing

    Time frame: 30 days following initiation of treatment

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Study locations

2 sites
  • Aston Ambulatory Care Center
    Dallas, Texas 75390-8866, United States
  • University of Texas Southwestern Medical Center at Dallas
    Dallas, Texas 75390-8866, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00344708
Lead sponsor
University of Texas Southwestern Medical Center
Responsible party
James McCulley (Chairman - Department of Ophthalmology, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Jun 27, 2006
Start date
Sep 2000
Primary completion
Apr 2010
Completion
Apr 2010
Last update
Aug 22, 2018

Study contacts

James P. McCulley, M.D.
principal investigator · University of Texas, Southwestern Medical Center at Dallas

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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