Limbal Stem-cell DeficiencyNCT03226015
Autologous Oral Mucosa Transplantation for Limbal Stem Cell Deficiency
An observational study of Limbal Stem-cell Deficiency, run by Klinikum Chemnitz gGmbH.
Trial summary
PURPOSE: To report clinical and histochemical results of oral mucosa graft transplantation in eyes with limbal stem cell deficiency. DESIGN: Prospective observational study. METHODS: 32 eyes of 27 patients with limbal stem cell deficiency underwent direct oral mucosa graft transplantation with amniotic membrane… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Limbal Stem-cell Deficiency
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to May 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients treated with oral mucosa with amniotic membrane transplantation in Klinikum Chemnitz 2015-2017
Who may be able to join
- limbal stem cell deficiency at least in one eye
- undergoing oral mucosa with amniotic membrane transplantation
- obtained written informed consent
Who cannot join
- no written informed consent
About this study
Official title: Autologous Oral Mucosa With Amniotic Membrane Transplantation for Limbal Stem Cell Deficiency: Clinical and Immunohistochemical Study
PURPOSE: To report clinical and histochemical results of oral mucosa graft transplantation in eyes with limbal stem cell deficiency.
DESIGN: Prospective observational study.
METHODS: 32 eyes of 27 patients with limbal stem cell deficiency underwent direct oral mucosa graft transplantation with amniotic membrane transplantation with a mean follow-up of 19 months. Clinical course of the disease including emergency surgeries, planned curative procedures, conjunctival inflammation, acute inpatient treatment and best corrected visual acuity were assessed at 3 months postoperatively and at last follow up visit. The unneeded parts of oral mucosa graft were analyzed immunohistochemically with staining for mesenchymal stem cell markers and pericytes (CD 90, CD 146, CD 166, CD 31, CD 68, protein gene product).
- Conditions
- Limbal Stem-cell Deficiency
- Keywords
- Limbal Stem-cell Deficiency, Oral mucosa transplantation, Amniotic membrane, Mesenchymal stem cells
- Medical subject headings
- Limbal Stem Cell Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
change in number of acute surgeries
Measured: baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months
change in days of acute inpatient treatment
Measured: baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months
Secondary outcomes (2)
change in number of curative surgical procedures after oral mucosa transplantation
Measured: baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months
change in conjunctival inflammation
Measured: baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study startJul 2015
- Primary completionApr 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limbal Stem-cell DeficiencyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum Chemnitz gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Anatomy TU Dresden
- Responsible party
- Principal investigator, Katrin Engelmann, Klinikum Chemnitz gGmbH
- Investigators
- Katrin Engelmann, PhD, Principal investigator, Klinikum Chemnitz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226015
- Sponsor's protocol ID
- EK-BR-64/15-1
- Status last verified
- Jul 2017
- First submitted
- 13 Jul 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Oral Mucosa With Amniotic Membrane Transplantation for Limbal Stem Cell Deficiency: Clinical and Immunohistochemical Study
- ClinicalTrials.gov ID
- NCT03226015
- Acronym / sponsor ID
- EK-BR-64/15-1
- Conditions
- Limbal Stem-cell Deficiency
- Keywords
- Limbal Stem-cell Deficiency, Oral mucosa transplantation, Amniotic membrane, Mesenchymal stem cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Klinikum Chemnitz gGmbHUniversity, hospital or other
- Collaborators
- Institute of Anatomy TU Dresden
- Study start
- Jul 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 21 Jul 2017 (actual)
- 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.
PURPOSE: To report clinical and histochemical results of oral mucosa graft transplantation in eyes with limbal stem cell deficiency.
DESIGN: Prospective observational study.
METHODS: 32 eyes of 27 patients with limbal stem cell deficiency underwent direct oral mucosa graft transplantation with amniotic membrane transplantation with a mean follow-up of 19 months. Clinical course of the disease including emergency surgeries, planned curative procedures, conjunctival inflammation, acute inpatient treatment and best corrected visual acuity were assessed at 3 months postoperatively and at last follow up visit. The unneeded parts of oral mucosa graft were analyzed immunohistochemically with staining for mesenchymal stem cell markers and pericytes (CD 90, CD 146, CD 166, CD 31, CD 68, protein gene product).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated with oral mucosa with amniotic membrane transplantation in Klinikum Chemnitz 2015-2017
Key inclusion criteria (3 listed)
- limbal stem cell deficiency at least in one eye
- undergoing oral mucosa with amniotic membrane transplantation
- obtained written informed consent
Key exclusion criteria (1 listed)
- no written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in number of acute surgeries
Time frame: baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months
change in days of acute inpatient treatment
Time frame: baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months
2 secondary outcomes
change in number of curative surgical procedures after oral mucosa transplantation
Time frame: baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months
change in conjunctival inflammation
Time frame: baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
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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.
Katrin Engelmann, PhD principal investigator
Klinikum Chemnitz
Questions about this trial
What is this clinical trial studying?
An observational study of Limbal Stem-cell Deficiency, run by Klinikum Chemnitz gGmbH.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change in number of acute surgeries (time frame: baseline, 3 months after oral mucosa transplantation; through study completion, an average of 19 months). The study lists 2 primary outcomes in all. 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 21 Jul 2017.