We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Safety Study of Stem Cell Transplant to Treat Limbus Insufficiency Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01562002
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : January 8, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of the study is to determine whether allogenic bone marrow stem cell transplant is safe and effective in the treatment of limbus insufficiency syndrome versus allogenic limbus stem cell transplant.

Condition or disease Intervention/treatment Phase
Limbus Corneae Insufficiency Syndrome Procedure: Stem Cell with Amniotic Membrane Transplant Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Advanced Therapy for Ocular Surface Reconstruction. Allogenic Limbus Epithelial Stem-cell Transplant vs Bone Marrow Mesenchymal Stem-cell Transplant in Limbus Insufficiency Syndrome. Double-masked Randomized Trial
Study Start Date : March 2012
Primary Completion Date : December 2014
Study Completion Date : December 2014
Arms and Interventions

Arm Intervention/treatment
Experimental: Bone Marrow mesenchymal stem cell
Allogenic Bone Marrow mesenchymal stem cell in amniotic membrane transplant
Procedure: Stem Cell with Amniotic Membrane Transplant
Single stem cell expansion in amniotic membrane transplant
Active Comparator: Allogenic limbal stem cell Transplant
Stem Cell with Amniotic Membrane Transplant
Procedure: Stem Cell with Amniotic Membrane Transplant
Single stem cell expansion in amniotic membrane transplant

Outcome Measures

Primary Outcome Measures :
  1. Viability and safety of mesenchymal stem cell transplant [ Time Frame: 1 Year ]
    Absence of cell metaplasia with phenotype different to corneal or conjunctival as expected, confirmed by corneal impression cytology and in vivo confocal laser ophthalmoscopy

Secondary Outcome Measures :
  1. Absence of complications in pre and peri surgical implantation [ Time Frame: 1 Week ]
    Correct handling and implantation of stem cell with amniotic membrane transplant following an 4 step classification.

  2. Improvement of 2 lines in Best Corrected Visual Acuity [ Time Frame: 12 month ]
    Improvement in visual acuity compared to baseline values before transplant

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or Female older than 18 years.
  • Signed Informed consent
  • Negative pregnancy test at inclusion for any potential childbearing female.
  • Compromise of contraceptive method during all trial for any potential childbearing female.
  • Diagnosis of Ocular Surface Failure due to Limbus Insufficiency Syndrome, based in any of the published characteristics as corneal surface neovascularization, loss of corneal transparency, epithelial irregularities, history of punctate keratitis, erosions or repetitive ulcers and presence of symptoms and confirmed by the presence of epithelial phenotype cells assessed with conjunctival impression cytology.
  • Availability for all the scheduled visits during the study

Exclusion Criteria:

  • Uncontrolled systemic disease (e.g. hypertension or diabetes) or any disease that under medical decision might put the patient at risk during the surgery or follow-up examinations or may cause any hazard in data analysis.
  • Active ocular infection in any eye. If the infection can be cured, inclusion can be considered after 30 days of inactive infection since its end.
  • Alterations in lid statics / dynamics or any other pathology (e.g. severe dry eye syndrome) except the one that originated the Limbus Insufficience that under medical opinion might alter the results. Any of these must be corrected 3 months prior to patient inclusion, before reconsidering rescreening.
  • Limbus insufficiency syndrome which has not been previously treated with all medical (not surgical) procedures available.
  • No availability for all scheduled visits during the study.
  • Any other circumstance under investigator´s opinion that prevents patient inclusion even though normal inclusion and exclusion criteria are met.
Contacts and Locations

Information from the National Library of Medicine

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): NCT01562002

Valladolid, Spain, 47011
Sponsors and Collaborators
Instituto Universitario de Oftalmobiología Aplicada
University of Valladolid
Centro en Red de Medicina Regenerativa de Castilla y Leon
Red de Terapia Celular
Principal Investigator: Margarita Calonge, MD, PhD Instituto Universitario de Oftalmobiología Aplicada
More Information

Responsible Party: Instituto Universitario de Oftalmobiología Aplicada
ClinicalTrials.gov Identifier: NCT01562002     History of Changes
Other Study ID Numbers: IOBA-05-2010
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: January 8, 2015
Last Verified: January 2015

Keywords provided by Instituto Universitario de Oftalmobiología Aplicada:
insufficiency syndrome
stem cell transplant

Additional relevant MeSH terms:
Pathologic Processes