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Stem Cells Treatment for Bilateral Limbic Associated Keratopathy (HULPOFT) (HULPOFT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01808378
Recruitment Status : Unknown
Verified September 2012 by Instituto de Investigación Hospital Universitario La Paz.
Recruitment status was:  Recruiting
First Posted : March 11, 2013
Last Update Posted : March 11, 2013
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz

Study Description
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Brief Summary:
Evaluate the use of the autologous ASC for the treatment of bilateral limbic associated keratopathy

Condition or disease Intervention/treatment Phase
Keratopathy Drug: Expanded adipose-derived stem cells Phase 2

Detailed Description:
Intralesional use by inject of adipose derived stem cells
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
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 : February 2013
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2014
Arms and Interventions
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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 Name: ASC


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate the practicability and security of the autologous expanded lipoaspirated stem cells for the treatment of bilateral limbic associated keratopathy [ Time Frame: 16 weeks ]
    Micro ocular Photography Visual acuity


Secondary Outcome Measures :
  1. Quality of life assessment using the SF-12 Questionnaire [ Time Frame: 1, 4, 16, 24 weeks ]
    SF-12 questionnaire

  2. Adverse events [ Time Frame: 1, 4, 16, 24 weeks ]
    Data collection


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808378


Contacts
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Contact: Mariano García-Arranz, PhD 0034 912071022 mgarciaa.hulp@salud.madrid.org
Contact: Ana Boto de los Bueis, MD 0034 912071022 mgarciaa.hulp@salud.madrid.org

Locations
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Spain
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Mariano García-Arranz, PhD    0034 912071022    mgarciaa.hulp@salud.madrid.org   
Principal Investigator: Ana Boto de los Bueis, MD         
Sub-Investigator: Mariano García-Arranz, MD         
Sub-Investigator: Almudena del Hierro, MD         
Sub-Investigator: Nerea Saenz, MD         
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Investigators
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Principal Investigator: Ana Boto de los Bueis, MD Hospital Universitario La Paz
More Information
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Publications:
Arntz Bustos A, Durán de la Colina JA. Anatomía funcional de la superficie ocular. En; Superficie Ocular. Ed S.E.O. 2004; 1-12
Yao YF, Inoue Y, Miyazaki K, Shimoura Y, Ohashi Y, Tano Y. Ocular resurfacing and alloepithelial suface reconstruction. Ophthalmol 2005; 112: 470-7

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Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT01808378    
Other Study ID Numbers: HULPOFT-2010-01
2010-024328-53 ( EudraCT Number )
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: March 11, 2013
Last Verified: September 2012
Keywords provided by Instituto de Investigación Hospital Universitario La Paz:
Bilateral limbic associated keratopathy
Expanded Adipose Derived Stem Cells