Safety Study of Stem Cell Transplant to Treat Limbus Insufficiency Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Limbus Corneae Insufficiency Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Bone Marrow mesenchymal stem cell

Allogenic Bone Marrow mesenchymal stem cell in amniotic membrane transplant

Group Type EXPERIMENTAL

Stem Cell with Amniotic Membrane Transplant

Intervention Type PROCEDURE

Single stem cell expansion in amniotic membrane transplant

Allogenic limbal stem cell Transplant

Stem Cell with Amniotic Membrane Transplant

Group Type ACTIVE_COMPARATOR

Stem Cell with Amniotic Membrane Transplant

Intervention Type PROCEDURE

Single stem cell expansion in amniotic membrane transplant

Interventions

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Stem Cell with Amniotic Membrane Transplant

Single stem cell expansion in amniotic membrane transplant

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No