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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2010-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Transplantation of Cultivated Limbal Epithelium on Amniotic Membrane for Limbal Stem Cell Deficiency

NCT00348114

Ocular Surface Disease

SUSPENDED PHASE2

Using Amniotic Membrane as the Carrier for ex Vivo Cell Culture for Cell Therapy in Ocular Surface Reconstruction

NCT01341223

Human Amniotic Membrane(AM)

UNKNOWN

The Application of Cultured Cornea Stem Cells in Patients Suffering From Corneal Stem Cell Insufficiency

NCT01377311

Unilateral Limbal Stem Cell Insufficiency

TERMINATED PHASE1

Autologous ex Vivo Conjunctival Epithelial Cell Expansion for Ocular Surface Transplantation

NCT00346450

Pterygium Ocular Surface Disease Stevens Johnson Syndrome +1 more

COMPLETED PHASE3

Treatment of PED With AMT and Autologous Serum

NCT00238862

Corneal Epithelial Defect

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Corneal Epithelial Dystrophy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transplantation of Tissue-Cultured Human Amniotic Epithelial Cells

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

88 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes