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Clinical Trials/EUCTR2010-024328-53-ES
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.

Registry
who.int
Start Date
December 12, 2011
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Fundación para la Investigación Biomédica del Hospital Universitario La Paz

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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