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

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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

Tracking Information
First Submitted Date  ICMJE September 4, 2012
First Posted Date  ICMJE March 11, 2013
Last Update Posted Date March 11, 2013
Study Start Date  ICMJE February 2013
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2013)
  • Quality of life assessment using the SF-12 Questionnaire [ Time Frame: 1, 4, 16, 24 weeks ]
    SF-12 questionnaire
  • Adverse events [ Time Frame: 1, 4, 16, 24 weeks ]
    Data collection
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stem Cells Treatment for Bilateral Limbic Associated Keratopathy (HULPOFT)
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Keratopathy
Intervention  ICMJE Drug: Expanded adipose-derived stem cells
Local injection of autologousadipose derived stem cells
Other Name: ASC
Study Arms  ICMJE Experimental: Autologous Stem Cells
Autologous expanded adipose-derived stem cells
Intervention: Drug: Expanded adipose-derived stem cells
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 7, 2013)
8
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01808378
Other Study ID Numbers  ICMJE HULPOFT-2010-01
2010-024328-53 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Instituto de Investigación Hospital Universitario La Paz
Study Sponsor  ICMJE Instituto de Investigación Hospital Universitario La Paz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ana Boto de los Bueis, MD Hospital Universitario La Paz
PRS Account Instituto de Investigación Hospital Universitario La Paz
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP