Safety Study of Stem Cell Transplant to Treat Limbus Insufficiency Syndrome

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

Status and phase

Completed

Phase 2

Phase 1

Conditions

Limbus Corneae Insufficiency Syndrome

Treatments

Procedure: Stem Cell with Amniotic Membrane Transplant

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01562002

IOBA-05-2010

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No 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 exclusion criteria are met.