EUCTR2010-024328-53-ES
Active, Not Recruiting
Phase 1
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 sitesDecember 12, 2011
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Keratopathy associated with bilateral limbic insufficiency.
- Sponsor
- Fundación para la Investigación Biomédica del Hospital Universitario La Paz
- Status
- Active, Not Recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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