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Status unknownNCT01808378HULPOFTUpdated Mar 11, 2013

Stem Cells Treatment for Bilateral Limbic Associated Keratopathy (HULPOFT)

A Phase 2 interventional study of Expanded adipose-derived stem cells in Keratopathy, sponsored by Instituto de Investigación Hospital Universitario La Paz. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-11.

Sponsored by Instituto de Investigación Hospital Universitario La Paz · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

Intralesional use by inject of adipose derived stem cells

02

Conditions studied

  • Keratopathy

Keywords

  • Bilateral limbic associated keratopathy
  • Expanded Adipose Derived Stem Cells
03

In context

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz is the lead sponsor of 100 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (estimated)

Study arms

  • Experimental
    Autologous Stem Cells

    Autologous expanded adipose-derived stem cells

    Drug: Expanded adipose-derived stem cells

Interventions

  • DrugExpanded adipose-derived stem cells

    Local injection of autologousadipose derived stem cells

    Also known as: ASC

06

What researchers measure

Primary outcomes

  1. Evaluate the practicability and security of the autologous expanded lipoaspirated stem cells for the treatment of bilateral limbic associated keratopathy

    Micro ocular Photography Visual acuity

    Time frame: 16 weeks

Secondary outcomes

  1. Quality of life assessment using the SF-12 Questionnaire

    SF-12 questionnaire

    Time frame: 1, 4, 16, 24 weeks

  2. Adverse events

    Data collection

    Time frame: 1, 4, 16, 24 weeks

07

Study locations

1 of 1 sites recruiting
  • Hospital Universitario La Paz
    Madrid, 28046, Spain
    • Mariano García-Arranz, PhD · Contact · mgarciaa.hulp@salud.madrid.org · 0034 912071022
    • Ana Boto de los Bueis, MD · Principal investigator
    • Mariano García-Arranz, MD · Sub investigator
    • Almudena del Hierro, MD · Sub investigator
    • Nerea Saenz, MD · Sub investigator
    Recruiting
08

References and documents

Publications

  • Nishida K. Tissue engineering of the cornea. Cornea. 2003 Oct;22(7 Suppl):S28-34. doi: 10.1097/00003226-200310001-00005. PubMed 14703705 ↗
  • Arntz Bustos A, Durán de la Colina JA. Anatomía funcional de la superficie ocular. En; Superficie Ocular. Ed S.E.O. 2004; 1-12
  • Schermer A, Galvin S, Sun TT. Differentiation-related expression of a major 64K corneal keratin in vivo and in culture suggests limbal location of corneal epithelial stem cells. J Cell Biol. 1986 Jul;103(1):49-62. doi: 10.1083/jcb.103.1.49. PubMed 2424919 ↗
  • Tseng SC. Staging of conjunctival squamous metaplasia by impression cytology. Ophthalmology. 1985 Jun;92(6):728-33. doi: 10.1016/s0161-6420(85)33967-2. PubMed 3897935 ↗
  • Kenyon KR, Tseng SC. Limbal autograft transplantation for ocular surface disorders. Ophthalmology. 1989 May;96(5):709-22; discussion 722-3. doi: 10.1016/s0161-6420(89)32833-8. PubMed 2748125 ↗
  • Santos MS, Gomes JA, Hofling-Lima AL, Rizzo LV, Romano AC, Belfort R Jr. Survival analysis of conjunctival limbal grafts and amniotic membrane transplantation in eyes with total limbal stem cell deficiency. Am J Ophthalmol. 2005 Aug;140(2):223-30. doi: 10.1016/j.ajo.2005.03.022. PubMed 16023069 ↗
  • Chen JJ, Tseng SC. Corneal epithelial wound healing in partial limbal deficiency. Invest Ophthalmol Vis Sci. 1990 Jul;31(7):1301-14. PubMed 1694836 ↗
  • Tan DT, Ficker LA, Buckley RJ. Limbal transplantation. Ophthalmology. 1996 Jan;103(1):29-36. doi: 10.1016/s0161-6420(96)30737-9. PubMed 8628556 ↗
  • Samson CM, Nduaguba C, Baltatzis S, Foster CS. Limbal stem cell transplantation in chronic inflammatory eye disease. Ophthalmology. 2002 May;109(5):862-8. doi: 10.1016/s0161-6420(02)00994-6. PubMed 11986089 ↗
  • Tsubota K, Toda I, Saito H, Shinozaki N, Shimazaki J. Reconstruction of the corneal epithelium by limbal allograft transplantation for severe ocular surface disorders. Ophthalmology. 1995 Oct;102(10):1486-96. doi: 10.1016/s0161-6420(95)30841-x. PubMed 9097796 ↗
  • Ilari L, Daya SM. Long-term outcomes of keratolimbal allograft for the treatment of severe ocular surface disorders. Ophthalmology. 2002 Jul;109(7):1278-84. doi: 10.1016/s0161-6420(02)01081-3. PubMed 12093650 ↗
  • Pellegrini G, De Luca M, Arsenijevic Y. Towards therapeutic application of ocular stem cells. Semin Cell Dev Biol. 2007 Dec;18(6):805-18. doi: 10.1016/j.semcdb.2007.09.011. Epub 2007 Sep 16. PubMed 17959397 ↗
  • Inatomi T, Nakamura T, Koizumi N, Sotozono C, Yokoi N, Kinoshita S. Midterm results on ocular surface reconstruction using cultivated autologous oral mucosal epithelial transplantation. Am J Ophthalmol. 2006 Feb;141(2):267-275. doi: 10.1016/j.ajo.2005.09.003. PubMed 16458679 ↗
  • Yao YF, Inoue Y, Miyazaki D, Shimomura Y, Ohashi Y, Tano Y. Ocular resurfacing and alloepithelial rejection in a murine keratoepithelioplasty model. Invest Ophthalmol Vis Sci. 1995 Dec;36(13):2623-33. PubMed 7499085 ↗
  • Daya SM, Watson A, Sharpe JR, Giledi O, Rowe A, Martin R, James SE. Outcomes and DNA analysis of ex vivo expanded stem cell allograft for ocular surface reconstruction. Ophthalmology. 2005 Mar;112(3):470-7. doi: 10.1016/j.ophtha.2004.09.023. PubMed 15745776 ↗
  • Nakamura T, Kinoshita S. Ocular surface reconstruction using cultivated mucosal epithelial stem cells. Cornea. 2003 Oct;22(7 Suppl):S75-80. doi: 10.1097/00003226-200310001-00011. PubMed 14703711 ↗
  • Nakamura T, Inatomi T, Sotozono C, Amemiya T, Kanamura N, Kinoshita S. Transplantation of cultivated autologous oral mucosal epithelial cells in patients with severe ocular surface disorders. Br J Ophthalmol. 2004 Oct;88(10):1280-4. doi: 10.1136/bjo.2003.038497. PubMed 15377551 ↗
  • Nishida K, Yamato M, Hayashida Y, Watanabe K, Yamamoto K, Adachi E, Nagai S, Kikuchi A, Maeda N, Watanabe H, Okano T, Tano Y. Corneal reconstruction with tissue-engineered cell sheets composed of autologous oral mucosal epithelium. N Engl J Med. 2004 Sep 16;351(12):1187-96. doi: 10.1056/NEJMoa040455. PubMed 15371576 ↗
  • Lehrer MS, Sun TT, Lavker RM. Strategies of epithelial repair: modulation of stem cell and transit amplifying cell proliferation. J Cell Sci. 1998 Oct;111 ( Pt 19):2867-75. doi: 10.1242/jcs.111.19.2867. PubMed 9730979 ↗
  • Ma Y, Xu Y, Xiao Z, Yang W, Zhang C, Song E, Du Y, Li L. Reconstruction of chemically burned rat corneal surface by bone marrow-derived human mesenchymal stem cells. Stem Cells. 2006 Feb;24(2):315-21. doi: 10.1634/stemcells.2005-0046. Epub 2005 Aug 18. PubMed 16109757 ↗
  • Blazejewska EA, Schlotzer-Schrehardt U, Zenkel M, Bachmann B, Chankiewitz E, Jacobi C, Kruse FE. Corneal limbal microenvironment can induce transdifferentiation of hair follicle stem cells into corneal epithelial-like cells. Stem Cells. 2009 Mar;27(3):642-52. doi: 10.1634/stemcells.2008-0721. PubMed 19074417 ↗
  • Gu S, Xing C, Han J, Tso MO, Hong J. Differentiation of rabbit bone marrow mesenchymal stem cells into corneal epithelial cells in vivo and ex vivo. Mol Vis. 2009;15:99-107. Epub 2009 Jan 16. PubMed 19156227 ↗
  • Arnalich-Montiel F, Pastor S, Blazquez-Martinez A, Fernandez-Delgado J, Nistal M, Alio JL, De Miguel MP. Adipose-derived stem cells are a source for cell therapy of the corneal stroma. Stem Cells. 2008 Feb;26(2):570-9. doi: 10.1634/stemcells.2007-0653. Epub 2007 Dec 6. PubMed 18065394 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01808378
Lead sponsor
Instituto de Investigación Hospital Universitario La Paz
Responsible party
Sponsor
First posted
Mar 11, 2013
Start date
Feb 2013
Primary completion
Dec 2013 (estimated)
Completion
Dec 2014 (estimated)
Last update
Mar 11, 2013

Study contacts

Mariano García-Arranz, PhD
Contact
mgarciaa.hulp@salud.madrid.org
0034 912071022
Ana Boto de los Bueis, MD
Contact
mgarciaa.hulp@salud.madrid.org
0034 912071022
Ana Boto de los Bueis, MD
principal investigator · Hospital Universitario La Paz

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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