Safety Study of Stem Cell Transplant to Treat Limbus Insufficiency Syndrome

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01562002

Enrollment

Registered

2012-03-23

Start date

2012-03-31

Completion date

2014-12-31

Last updated

2015-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Limbus Corneae Insufficiency Syndrome

Keywords

limbus, cornea, insufficiency syndrome, stem cell transplant

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.

Interventions

PROCEDUREStem Cell with Amniotic Membrane Transplant

Single stem cell expansion in amniotic membrane transplant

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026