Safety Study of Stem Cell Transplant to Treat Limbus Insufficiency Syndrome
This study is currently recruiting participants.
Verified September 2012 by Instituto Universitario de Oftalmobiología Aplicada
Sponsor:
Instituto Universitario de Oftalmobiología Aplicada
Collaborators:
University of Valladolid
Centro en Red de Medicina Regenerativa de Castilla y Leon
Red de Terapia Celular
Information provided by (Responsible Party):
Instituto Universitario de Oftalmobiología Aplicada
ClinicalTrials.gov Identifier:
NCT01562002
First received: March 22, 2012
Last updated: September 26, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Limbus Corneae Insufficiency Syndrome |
Procedure: Stem Cell with Amniotic Membrane Transplant |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Instituto Universitario de Oftalmobiología Aplicada:
Primary Outcome Measures:
- Viability and safety of mesenchymal stem cell transplant [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]Absence of cell metaplasia with phenotype different to corneal or conjunctival as expected, confirmed by corneal impression cytology and in vivo confocal laser ophthalmoscopy
Secondary Outcome Measures:
- Absence of complications in pre and peri surgical implantation [ Time Frame: 1 Week ] [ Designated as safety issue: Yes ]Correct handling and implantation of stem cell with amniotic membrane transplant following an 4 step classification.
- Improvement of 2 lines in Best Corrected Visual Acuity [ Time Frame: 12 month ] [ Designated as safety issue: No ]Improvement in visual acuity compared to baseline values before transplant
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Bone Marrow mesenchymal stem cell
Allogenic Bone Marrow mesenchymal stem cell in amniotic membrane transplant
|
Procedure: Stem Cell with Amniotic Membrane Transplant
Single stem cell expansion in amniotic membrane transplant
|
|
Active Comparator: Allogenic limbal stem cell Transplant
Stem Cell with Amniotic Membrane Transplant
|
Procedure: Stem Cell with Amniotic Membrane Transplant
Single stem cell expansion in amniotic membrane transplant
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562002
Contacts
| Contact: Margarita Calonge, MD, PhD | 34983184750 | calonge.@ioba.med.uva.es |
| Contact: Francisco Blazquez, MD, MsC | 34983184734 | blazquez@ioba.med.uva.es |
Locations
| Spain | |
| IOBA | Recruiting |
| Valladolid, Spain, 47011 | |
| Contact: Francisco Blazquez, MD, MsC 34983184734 blazquez@ioba.med.uva.es | |
| Contact: Margarita Calonge, MD, PhD 34983184750 calonge@ioba.med.uva.es | |
| Principal Investigator: Margarita Calonge, MD, PhD | |
| Sub-Investigator: Jose Maria Herreras, MD, PhD | |
| Sub-Investigator: Francisco Blazquez, MD, MsC | |
| Sub-Investigator: Esther Carreño, MD, MsC | |
Sponsors and Collaborators
Instituto Universitario de Oftalmobiología Aplicada
University of Valladolid
Centro en Red de Medicina Regenerativa de Castilla y Leon
Red de Terapia Celular
Investigators
| Principal Investigator: | Margarita Calonge, MD, PhD | Instituto Universitario de Oftalmobiología Aplicada |
More Information
No publications provided
| Responsible Party: | Instituto Universitario de Oftalmobiología Aplicada |
| ClinicalTrials.gov Identifier: | NCT01562002 History of Changes |
| Other Study ID Numbers: | IOBA-05-2010 |
| Study First Received: | March 22, 2012 |
| Last Updated: | September 26, 2012 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios |
Keywords provided by Instituto Universitario de Oftalmobiología Aplicada:
|
limbus cornea insufficiency syndrome stem cell transplant |
ClinicalTrials.gov processed this record on May 22, 2013