Safety Study of Stem Cell Transplant to Treat Limbus Insufficiency Syndrome

Phase 1

Completed

• Conditions: Limbus Corneae Insufficiency Syndrome
• Interventions: Procedure: Stem Cell with Amniotic Membrane Transplant

• Registration Number: NCT01562002
• Lead Sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-23
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-07
• Last Update Posted: 2015-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allogenic limbal stem cell Transplant	Stem Cell with Amniotic Membrane Transplant	Stem Cell with Amniotic Membrane Transplant
Bone Marrow mesenchymal stem cell	Stem Cell with Amniotic Membrane Transplant	Allogenic Bone Marrow mesenchymal stem cell in amniotic membrane transplant

Primary Outcome Measures

Name	Time	Method
Viability and safety of mesenchymal stem cell transplant	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

Secondary Outcome Measures

Name	Time	Method
Absence of complications in pre and peri surgical implantation	1 Week	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	12 month	Improvement in visual acuity compared to baseline values before transplant

Trial Locations

Locations (1)

IOBA; 🇪🇸 Valladolid, Spain