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
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Condition or disease | Intervention/treatment | Phase |
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Keratopathy | Drug: Expanded adipose-derived stem cells | Phase 2 |
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 |
Arm | Intervention/treatment |
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Experimental: Autologous Stem Cells
Autologous expanded adipose-derived stem cells
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Drug: Expanded adipose-derived stem cells
Local injection of autologousadipose derived stem cells
Other Name: ASC |
- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- -Signed informed consent
- -Previously diagnosed bilateral limbic obstruction
- -Men and women over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
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-Suffering chronic keratopathy accomplishing the following criteria:
- Confirmed limbic obstruction with an impression cytology
- Repeated usual treatment failure for this pathology
Exclusion Criteria:
- -Having suffered a neoplasia in the previous 5 years
- -Local anesthesia allergies
- -Patients having participate in any other study in the previous 90 days to the inclusion
- -Patients on medication with tacrolimus or cyclosporine in the 4 previous week to the cellular therapy
- -Any medical or psychiatric illness that, in the investigator opinion, could suppose a reason for the study exclusion
- -Patients with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from study
- -Patients with congenital or acquired immunodeficiencies. HIV, HBV, HCV or treponema infection, whether active or latent
- -Patients who have suffering major surgery or severe trauma in the prior 6 months
- -Pregnant or breastfeeding women

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
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 |
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 |
Principal Investigator: | Ana Boto de los Bueis, MD | Hospital Universitario La Paz |
Publications:
Responsible Party: | Instituto de Investigación Hospital Universitario La Paz |
ClinicalTrials.gov Identifier: | NCT01808378 History of Changes |
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 |
Bilateral limbic associated keratopathy Expanded Adipose Derived Stem Cells |