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

March 7, 2013 updated by: Instituto de Investigación Hospital Universitario La Paz

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Intralesional use by inject of adipose derived stem cells

Study Type

Interventional

Enrollment (Anticipated)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Principal Investigator:
          • Ana Boto de los Bueis, MD
        • Sub-Investigator:
          • Almudena del Hierro, MD
        • Sub-Investigator:
          • Nerea Saenz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

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
Time Frame: 16 weeks
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
Time Frame: 1, 4, 16, 24 weeks
SF-12 questionnaire
1, 4, 16, 24 weeks
Adverse events
Time Frame: 1, 4, 16, 24 weeks
Data collection
1, 4, 16, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

September 4, 2012

First Submitted That Met QC Criteria

March 7, 2013

First Posted (Estimate)

March 11, 2013

Study Record Updates

Last Update Posted (Estimate)

March 11, 2013

Last Update Submitted That Met QC Criteria

March 7, 2013

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HULPOFT-2010-01
  • 2010-024328-53 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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