Stem Cells Treatment for Bilateral Limbic Associated Keratopathy (HULPOFT)

Study Overview
=================
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

Official Title
-----------------
Phase IIa Clinical Trial to Study the Feasability and Security of the Expanded Autologous Stem Cells (ASC) From Lipoaspirate in the Bilateral Limbic Associated Keratopathy Treatment

Conditions
-----------------
Keratopathy

Intervention / Treatment
-----------------
* Drug: Expanded adipose-derived stem cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -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 Criteria: -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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous Stem Cells<br>Autologous expanded adipose-derived stem cells | Drug: Expanded adipose-derived stem cells<br>* Local injection of autologousadipose derived stem cells<br>* Other names: ASC;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the practicability and security of the autologous expanded lipoaspirated stem cells for the treatment of bilateral limbic associated keratopathy | Micro ocular Photography Visual acuity | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life assessment using the SF-12 Questionnaire | SF-12 questionnaire | 1, 4, 16, 24 weeks | 
| Adverse events | Data collection | 1, 4, 16, 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bilateral limbic associated keratopathy, Expanded Adipose Derived Stem Cells