Stem Cells Treatment for Bilateral Limbic Associated Keratopathy (HULPOFT)

Phase 2

• Conditions: Keratopathy
• Interventions: Drug: Expanded adipose-derived stem cells

• Registration Number: NCT01808378
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

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

Study Timeline

• Status Verified: 2012-09
• Study First Submitted: 2012-09-04
• Study Start: 2013-02
• Study First Submitted QC: 2013-03-07
• Last Update Submitted: 2013-03-07
• Study First Posted: 2013-03-11
• Last Update Posted: 2013-03-11
• Primary Completion: 2013-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1. -Signed informed consent

2. -Previously diagnosed bilateral limbic obstruction

3. -Men and women over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination

4. -Suffering chronic keratopathy accomplishing the following criteria:

   • Confirmed limbic obstruction with an impression cytology
   • Repeated usual treatment failure for this pathology

Exclusion Criteria

1. -Having suffered a neoplasia in the previous 5 years
2. -Local anesthesia allergies
3. -Patients having participate in any other study in the previous 90 days to the inclusion
4. -Patients on medication with tacrolimus or cyclosporine in the 4 previous week to the cellular therapy
5. -Any medical or psychiatric illness that, in the investigator opinion, could suppose a reason for the study exclusion
6. -Patients with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from study
7. -Patients with congenital or acquired immunodeficiencies. HIV, HBV, HCV or treponema infection, whether active or latent
8. -Patients who have suffering major surgery or severe trauma in the prior 6 months
9. -Pregnant or breastfeeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous Stem Cells	Expanded adipose-derived stem cells	Autologous expanded adipose-derived stem cells

Primary Outcome Measures

Name	Time	Method
Evaluate the practicability and security of the autologous expanded lipoaspirated stem cells for the treatment of bilateral limbic associated keratopathy	16 weeks	Micro ocular Photography Visual acuity

Secondary Outcome Measures

Name	Time	Method
Adverse events	1, 4, 16, 24 weeks	Data collection
Quality of life assessment using the SF-12 Questionnaire	1, 4, 16, 24 weeks	SF-12 questionnaire

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain