Limbus Corneae Insufficiency SyndromePhase 1/2NCT01562002
Safety Study of Stem Cell Transplant to Treat Limbus Insufficiency Syndrome
A Phase 1/2 study testing Stem Cell with Amniotic Membrane Transplant in people with Limbus Corneae Insufficiency Syndrome, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA at 1 site in Spain.
Trial summary
The purpose of the study is to determine whether allogenic bone marrow stem cell transplant is safe and effective in the treatment of limbus insufficiency syndrome versus allogenic limbus stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Limbus Corneae Insufficiency Syndrome
- What is being tested?
- Stem Cell with Amniotic Membrane Transplant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2012to Dec 2014
- Phase
- Phase 1/2
- 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
Who may be able to join
- Male or Female older than 18 years.
- Signed Informed consent
- Negative pregnancy test at inclusion for any potential childbearing female.
- Compromise of contraceptive method during all trial for any potential childbearing female.
- Diagnosis of Ocular Surface Failure due to Limbus Insufficiency Syndrome, based in any of the published characteristics as corneal surface neovascularization, loss of corneal transparency, epithelial irregularities, history of punctate keratitis, erosions or repetitive ulcers and presence of symptoms and confirmed by the presence of epithelial phenotype cells assessed with conjunctival impression cytology.
- Availability for all the scheduled visits during the study
Who cannot join
- Uncontrolled systemic disease (e.g. hypertension or diabetes) or any disease that under medical decision might put the patient at risk during the surgery or follow-up examinations or may cause any hazard in data analysis.
- Active ocular infection in any eye. If the infection can be cured, inclusion can be considered after 30 days of inactive infection since its end.
- Alterations in lid statics / dynamics or any other pathology (e.g. severe dry eye syndrome) except the one that originated the Limbus Insufficience that under medical opinion might alter the results. Any of these must be corrected 3 months prior to patient inclusion, before reconsidering rescreening.
- Limbus insufficiency syndrome which has not been previously treated with all medical (not surgical) procedures available.
- No availability for all scheduled visits during the study.
- Any other circumstance under investigator´s opinion that prevents patient inclusion even though normal inclusion and exclusion criteria are met.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Advanced Therapy for Ocular Surface Reconstruction. Allogenic Limbus Epithelial Stem-cell Transplant vs Bone Marrow Mesenchymal Stem-cell Transplant in Limbus Insufficiency Syndrome. Double-masked Randomized Trial
The purpose of the study is to determine whether allogenic bone marrow stem cell transplant is safe and effective in the treatment of limbus insufficiency syndrome versus allogenic limbus stem cell transplant.
- Conditions
- Limbus Corneae Insufficiency Syndrome
- Being tested
- Stem Cell with Amniotic Membrane Transplant
- Keywords
- limbus, cornea, insufficiency syndrome, stem cell transplant
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem Cell with Amniotic Membrane TransplantProcedure or surgery
Single stem cell expansion in amniotic membrane transplant
| Study group | Role | What they receive |
|---|---|---|
| Bone Marrow mesenchymal stem cell | Experimental | Allogenic Bone Marrow mesenchymal stem cell in amniotic membrane transplant Receives: Procedure: Stem Cell with Amniotic Membrane Transplant |
| Allogenic limbal stem cell Transplant | Active comparator | Stem Cell with Amniotic Membrane Transplant Receives: Procedure: Stem Cell with Amniotic Membrane Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viability and safety of mesenchymal stem cell transplant
Absence of cell metaplasia with phenotype different to corneal or conjunctival as expected, confirmed by corneal impression cytology and in vivo confocal laser ophthalmoscopy
Measured: 1 Year
Secondary outcomes (2)
Absence of complications in pre and peri surgical implantation
Correct handling and implantation of stem cell with amniotic membrane transplant following an 4 step classification.
Measured: 1 Week
Improvement of 2 lines in Best Corrected Visual Acuity
Improvement in visual acuity compared to baseline values before transplant
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Limbus Corneae Insufficiency SyndromeStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
- Sponsor type
- University, hospital or other
- Collaborators
- University of Valladolid, Centro en Red de Medicina Regenerativa de Castilla y Leon, Red de Terapia Celular
- Responsible party
- Sponsor
- Investigators
- Margarita Calonge, MD, PhD, Principal investigator, Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562002
- Sponsor's protocol ID
- IOBA-05-2010
- Status last verified
- Jan 2015
- First submitted
- 22 Mar 2012
- Last updated
- 8 Jan 2015
- Results posted
- No
Publications
Perez I, Galindo S, Lopez-Miguel A, Nieto-Miguel T, de la Mata A, Lopez-Paniagua M, Alberca M, Herreras JM, Calonge M. In Vivo Confocal Microscopy in Limbal Stem Cell Deficiency After Mesenchymal Stem Cell Transplantation: A Sub-analysis from a Phase I-II Clinical Trial. Ophthalmol Ther. 2023 Dec;12(6):3251-3262. doi: 10.1007/s40123-023-00809-7. Epub 2023 Sep 29.
PubMed 37773479Calonge M, Perez I, Galindo S, Nieto-Miguel T, Lopez-Paniagua M, Fernandez I, Alberca M, Garcia-Sancho J, Sanchez A, Herreras JM. A proof-of-concept clinical trial using mesenchymal stem cells for the treatment of corneal epithelial stem cell deficiency. Transl Res. 2019 Apr;206:18-40. doi: 10.1016/j.trsl.2018.11.003. Epub 2018 Nov 22.
PubMed 30578758
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Therapy for Ocular Surface Reconstruction. Allogenic Limbus Epithelial Stem-cell Transplant vs Bone Marrow Mesenchymal Stem-cell Transplant in Limbus Insufficiency Syndrome. Double-masked Randomized Trial
- ClinicalTrials.gov ID
- NCT01562002
- Acronym / sponsor ID
- IOBA-05-2010
- Conditions
- Limbus Corneae Insufficiency Syndrome
- Keywords
- limbus, cornea, insufficiency syndrome, stem cell transplant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBAUniversity, hospital or other
- Collaborators
- University of Valladolid, Centro en Red de Medicina Regenerativa de Castilla y Leon, Red de Terapia Celular
- Study start
- Mar 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Mar 2012 (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.
The purpose of the study is to determine whether allogenic bone marrow stem cell transplant is safe and effective in the treatment of limbus insufficiency syndrome versus allogenic limbus stem cell transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone Marrow mesenchymal stem cell | Experimental | Procedure: Stem Cell with Amniotic Membrane TransplantAllogenic Bone Marrow mesenchymal stem cell in amniotic membrane transplant |
| Allogenic limbal stem cell Transplant | Active comparator | Procedure: Stem Cell with Amniotic Membrane TransplantStem Cell with Amniotic Membrane Transplant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Female older than 18 years.
- Signed Informed consent
- Negative pregnancy test at inclusion for any potential childbearing female.
- Compromise of contraceptive method during all trial for any potential childbearing female.
- Diagnosis of Ocular Surface Failure due to Limbus Insufficiency Syndrome, based in any of the published characteristics as corneal surface neovascularization, loss of corneal transparency, epithelial irregularities, history of punctate keratitis, erosions or repetitive ulcers and presence of symptoms and confirmed by the presence of epithelial phenotype cells assessed with conjunctival impression cytology.
Key exclusion criteria (6 listed)
- Uncontrolled systemic disease (e.g. hypertension or diabetes) or any disease that under medical decision might put the patient at risk during the surgery or follow-up examinations or may cause any hazard in data analysis.
- Active ocular infection in any eye. If the infection can be cured, inclusion can be considered after 30 days of inactive infection since its end.
- Alterations in lid statics / dynamics or any other pathology (e.g. severe dry eye syndrome) except the one that originated the Limbus Insufficience that under medical opinion might alter the results. Any of these must be corrected 3 months prior to patient inclusion, before reconsidering rescreening.
- Limbus insufficiency syndrome which has not been previously treated with all medical (not surgical) procedures available.
- No availability for all scheduled visits during the study.
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 |
|---|---|---|
| Stem Cell with Amniotic Membrane TransplantSingle stem cell expansion in amniotic membrane transplant | Procedure or surgery | Allogenic limbal stem cell Transplant, Bone Marrow mesenchymal stem cell |
Primary outcome
Viability and safety of mesenchymal stem cell transplant
Time frame: 1 Year
Absence of cell metaplasia with phenotype different to corneal or conjunctival as expected, confirmed by corneal impression cytology and in vivo confocal laser ophthalmoscopy
2 secondary outcomes
Absence of complications in pre and peri surgical implantation
Time frame: 1 Week
Improvement of 2 lines in Best Corrected Visual Acuity
Time frame: 12 month
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 8 Jan 2015.
- Derived from this study: PubMed 37773479Perez I, Galindo S, Lopez-Miguel A, Nieto-Miguel T, de la Mata A, Lopez-Paniagua M, Alberca M, Herreras JM, Calonge M. In Vivo Confocal Microscopy in Limbal Stem Cell Deficiency After Mesenchymal Stem Cell Transplantation: A Sub-analysis from a Phase I-II Clinical Trial. Ophthalmol Ther. 2023 Dec;12(6):3251-3262. doi: 10.1007/s40123-023-00809-7. Epub 2023 Sep 29.
- Derived from this study: PubMed 30578758Calonge M, Perez I, Galindo S, Nieto-Miguel T, Lopez-Paniagua M, Fernandez I, Alberca M, Garcia-Sancho J, Sanchez A, Herreras JM. A proof-of-concept clinical trial using mesenchymal stem cells for the treatment of corneal epithelial stem cell deficiency. Transl Res. 2019 Apr;206:18-40. doi: 10.1016/j.trsl.2018.11.003. Epub 2018 Nov 22.
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.
Margarita Calonge, MD, PhD principal investigator
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Stem Cell with Amniotic Membrane Transplant in people with Limbus Corneae Insufficiency Syndrome, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA at 1 site in Spain.
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 6 inclusion and 6 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 8 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Viability and safety of mesenchymal stem cell transplant (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01562002, which also lists 2 linked publications.
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 8 Jan 2015.