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Stem Cells Treatment for Bilateral Limbic Associated Keratopathy (HULPOFT)

Sponsor
Instituto de Investigación Hospital Universitario La Paz (Other)
Overall Status
Unknown status
CT.gov ID
NCT01808378
Collaborator
(none)
8
Enrollment
1
Location
1
Arm
21.9
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluate the use of the autologous ASC for the treatment of bilateral limbic associated keratopathy

Condition or Disease Intervention/Treatment Phase
  • Drug: Expanded adipose-derived stem cells
 Phase 2

Detailed Description

Intralesional use by inject of adipose derived stem cells

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Feb 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2013
Anticipated Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Autologous Stem Cells

Autologous expanded adipose-derived stem cells

Drug: Expanded adipose-derived stem cells
Local injection of autologousadipose derived stem cells
Other Names:
  • ASC

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Quality of life assessment using the SF-12 Questionnaire [1, 4, 16, 24 weeks]

      SF-12 questionnaire

    2. Adverse events [1, 4, 16, 24 weeks]

      Data collection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitario La Paz Madrid Spain 28046

    Sponsors and Collaborators

    • Instituto de Investigación Hospital Universitario La Paz

    Investigators

    • Principal Investigator: Ana Boto de los Bueis, MD, Hospital Universitario La Paz

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Instituto de Investigación Hospital Universitario La Paz
    ClinicalTrials.gov Identifier:
    NCT01808378
    Other Study ID Numbers:
    • HULPOFT-2010-01
    • 2010-024328-53
    First Posted:
    Mar 11, 2013
    Last Update Posted:
    Mar 11, 2013
    Last Verified:
    Sep 1, 2012
    Keywords provided by Instituto de Investigación Hospital Universitario La Paz
    Bilateral limbic associated keratopathy
    Expanded Adipose Derived Stem Cells

    Study Results

    No Results Posted as of Mar 11, 2013