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

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA1 个研究点分布在 1 个国家目标入组 27 人2012年3月

适应症Limbus Corneae Insufficiency Syndrome

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Limbus Corneae Insufficiency Syndrome
发起方: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
入组人数: 27
试验地点: 1
主要终点: Viability and safety of mesenchymal stem cell transplant
状态: 已完成
最后更新: 11年前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

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.

注册库

clinicaltrials.gov

开始日期

2012年3月

结束日期

2014年12月

最后更新

11年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

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

责任方

Sponsor

入排标准

入选标准

•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

排除标准

•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.

结局指标

主要结局

Viability and safety of mesenchymal stem cell transplant

时间窗: 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