Corneal Epithelial DystrophyNCT00344708
Transplantation of Tissue Cultured Human Amniotic Epithelial Cells Onto Damaged Ocular Surfaces
A study testing Transplantation of Tissue-Cultured Human Amniotic Epithelial Cells in people with Corneal Epithelial Dystrophy, run by University of Texas Southwestern Medical Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 88 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Corneal Epithelial Dystrophy
- What is being tested?
- Transplantation of Tissue-Cultured Human Amniotic Epithelial Cells
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2000to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Aston Ambulatory Care Center
Dallas, Texas, 75390-8866
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390-8866
About this study
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.
- Conditions
- Corneal Epithelial Dystrophy
- Being tested
- Transplantation of Tissue-Cultured Human Amniotic Epithelial Cells
- Keywords
- Tissue-Cultured Human Amniotic Epithelial Cells onto damaged corneal surface
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transplantation of Tissue-Cultured Human Amniotic Epithelial CellsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular surface healing
Measured: 30 days following initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2006 (estimated)
- Study startSep 2000
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: Potential subjects did not meet eligibility criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Epithelial DystrophyStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James McCulley, University of Texas Southwestern Medical Center
- Investigators
- James P. McCulley, M.D., Principal investigator, University of Texas, Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344708
- Sponsor's protocol ID
- 0399-090
- Status last verified
- Aug 2018
- First submitted
- 23 Jun 2006
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplantation of Tissue Cultured Human Amniotic Epithelial Cells Onto Damaged Ocular Surfaces
- ClinicalTrials.gov ID
- NCT00344708
- Acronym / sponsor ID
- 0399-090
- Conditions
- Corneal Epithelial Dystrophy
- Keywords
- Tissue-Cultured Human Amniotic Epithelial Cells onto damaged corneal surface
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Potential subjects did not meet eligibility criteria
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Sep 2000
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 27 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 88 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- Patients who are pregnant or under age 18 will be excluded.
- Placentas will not be used if the following problems are present:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transplantation of Tissue-Cultured Human Amniotic Epithelial Cells | Procedure or surgery | – |
Primary outcome
Ocular surface healing
Time frame: 30 days following initiation of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James P. McCulley, M.D. principal investigator
University of Texas, Southwestern Medical Center at Dallas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transplantation of Tissue-Cultured Human Amniotic Epithelial Cells in people with Corneal Epithelial Dystrophy, run by University of Texas Southwestern Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular surface healing (time frame: 30 days following initiation of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.