Phase IIa clinical trial to determine the feasibility and safety of using autologous expanded stem cell (ASC) from fat in the treatment of keratopathy associated with bilateral limbic insufficiency - FLPURO-2010-01

Fundación para la Investigación Biomédica del Hospital Universitario La Paz0 个研究点开始时间: 2011年12月12日最近更新: 2016年8月8日

适应症

试验速览

暂无简介。

•1 .- Over 18 years old in good general health, according to data from the clinical history and physical examination.
•2 .- Previous diagnosis of bilateral IL.
•3 .- Have chronic keratopathy under the following conditions:
•Confimación of IL through impression cytology
•Repeated failure of standard treatments for this condition
•4 .- Signing of informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 8
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1 .- Do not meet any criteria for inclusion
•2 .- History of malignancy within the last 5 years.
•3 .- Allergy to local anesthetics
•4 .- Patients who have participated in other studies during the 90 days prior to their inclusion.
•5 .- Tacrolimus or cyclosporine administration in the 4 weeks prior to cell therapy.
•6 .- Medical or psychiatric illness of any kind, according to the investigator, may be a reason for exclusion from the study.
•7 .- Subjects with congenital or acquired immunodeficiencies. Syphilis, Hepatitis B and / or C or tuberculosis diagnosed at the time of inclusion.
•8 .- Major surgery or major trauma of the subject in the previous semester.
•9 .- Pregnant or lactating women.

发起方

Fundación para la Investigación Biomédica del Hospital Universitario La Paz