NCT01808378

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 11, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 11, 2013

Status Verified

September 1, 2012

Enrollment Period

10 months

First QC Date

September 4, 2012

Last Update Submit

March 7, 2013

Conditions

Keratopathy

Keywords

Bilateral limbic associated keratopathyExpanded Adipose Derived Stem Cells

Outcome Measures

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

    16 weeks

Secondary Outcomes (2)

  • Quality of life assessment using the SF-12 Questionnaire

    1, 4, 16, 24 weeks

  • Adverse events

    1, 4, 16, 24 weeks

Study Arms (1)

Autologous Stem Cells

EXPERIMENTAL

Autologous expanded adipose-derived stem cells

Drug: Expanded adipose-derived stem cells

Interventions

Expanded adipose-derived stem cellsDRUG

Local injection of autologousadipose derived stem cells

Also known as: ASC
Autologous Stem Cells

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Suffering chronic keratopathy accomplishing the following criteria:
  • Confirmed limbic obstruction with an impression cytology
  • Repeated usual treatment failure for this pathology

You may not qualify if:

  • Having suffered a neoplasia in the previous 5 years
  • Local anesthesia allergies
  • Patients on medication with tacrolimus or cyclosporine in the 4 previous week to the cellular therapy
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

RECRUITING

Related Publications (24)

  • Nishida K. Tissue engineering of the cornea. Cornea. 2003 Oct;22(7 Suppl):S28-34. doi: 10.1097/00003226-200310001-00005.

    PMID: 14703705BACKGROUND

  • Arntz Bustos A, Durán de la Colina JA. Anatomía funcional de la superficie ocular. En; Superficie Ocular. Ed S.E.O. 2004; 1-12

    BACKGROUND

  • 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.

    PMID: 2424919BACKGROUND

  • 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.

    PMID: 3897935BACKGROUND

  • 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.

    PMID: 2748125BACKGROUND

  • 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.

    PMID: 16023069BACKGROUND

  • Chen JJ, Tseng SC. Corneal epithelial wound healing in partial limbal deficiency. Invest Ophthalmol Vis Sci. 1990 Jul;31(7):1301-14.

    PMID: 1694836BACKGROUND

  • Tan DT, Ficker LA, Buckley RJ. Limbal transplantation. Ophthalmology. 1996 Jan;103(1):29-36. doi: 10.1016/s0161-6420(96)30737-9.

    PMID: 8628556BACKGROUND

  • 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.

    PMID: 11986089BACKGROUND

  • 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.

    PMID: 9097796BACKGROUND

  • 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.

    PMID: 12093650BACKGROUND

  • 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.

    PMID: 17959397BACKGROUND

  • 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.

    PMID: 16458679BACKGROUND

  • 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.

    PMID: 7499085BACKGROUND

  • 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.

    PMID: 15745776BACKGROUND

  • 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.

    PMID: 14703711BACKGROUND

  • 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.

    PMID: 15377551BACKGROUND

  • 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.

    PMID: 15371576BACKGROUND

  • 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.

    PMID: 9730979BACKGROUND

  • 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.

    PMID: 16109757BACKGROUND

  • 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.

    PMID: 19074417BACKGROUND

  • 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.

    PMID: 19156227BACKGROUND

  • 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.

    PMID: 18065394BACKGROUND

  • Boto de Los Bueis A, Vidal Arranz C, Del Hierro-Zarzuelo A, Diaz Valle D, Mendez Fernandez R, Gabarron Hermosilla MI, Benitez Del Castillo JM, Garcia-Arranz M. Long-Term Effects of Adipose-Derived Stem Cells for the Treatment of Bilateral Limbal Stem Cell Deficiency. Curr Eye Res. 2024 Apr;49(4):345-353. doi: 10.1080/02713683.2023.2297342. Epub 2023 Dec 28.

    PMID: 38152876DERIVED

Study Officials

  • Ana Boto de los Bueis, MD

    Hospital Universitario La Paz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariano García-Arranz, PhD

CONTACT

0034 912071022mgarciaa.hulp@salud.madrid.org

Ana Boto de los Bueis, MD

CONTACT

0034 912071022mgarciaa.hulp@salud.madrid.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2012

First Posted

March 11, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

March 11, 2013

Record last verified: 2012-09

Locations

ES(1)