Status:
UNKNOWN
Stem Cells Treatment for Bilateral Limbic Associated Keratopathy (HULPOFT)
Lead Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Conditions:
Keratopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Evaluate the use of the autologous ASC for the treatment of bilateral limbic associated keratopathy
Detailed Description
Intralesional use by inject of adipose derived stem cells
Eligibility Criteria
Inclusion
- -Signed informed consent
- -Previously diagnosed bilateral limbic obstruction
- -Men and women over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
- -Suffering chronic keratopathy accomplishing the following criteria:
- Confirmed limbic obstruction with an impression cytology
- Repeated usual treatment failure for this pathology
Exclusion
- -Having suffered a neoplasia in the previous 5 years
- -Local anesthesia allergies
- -Patients having participate in any other study in the previous 90 days to the inclusion
- -Patients on medication with tacrolimus or cyclosporine in the 4 previous week to the cellular therapy
- -Any medical or psychiatric illness that, in the investigator opinion, could suppose a reason for the study exclusion
- -Patients with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from study
- -Patients with congenital or acquired immunodeficiencies. HIV, HBV, HCV or treponema infection, whether active or latent
- -Patients who have suffering major surgery or severe trauma in the prior 6 months
- -Pregnant or breastfeeding women
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01808378
Start Date
February 1 2013
End Date
December 1 2014
Last Update
March 11 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046