Safety Study of Stem Cell Transplant to Treat Limbus Insufficiency Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Valladolid
Centro en Red de Medicina Regenerativa de Castilla y Leon
Red de Terapia Celular
Information provided by (Responsible Party):
Instituto Universitario de Oftalmobiología Aplicada
ClinicalTrials.gov Identifier:
NCT01562002
First received: March 22, 2012
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Limbus Corneae Insufficiency Syndrome
Procedure: Stem Cell with Amniotic Membrane Transplant
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Instituto Universitario de Oftalmobiología Aplicada:

Primary Outcome Measures:
  • Viability and safety of mesenchymal stem cell transplant [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
    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:
  • Absence of complications in pre and peri surgical implantation [ Time Frame: 1 Week ] [ Designated as safety issue: Yes ]
    Correct handling and implantation of stem cell with amniotic membrane transplant following an 4 step classification.

  • Improvement of 2 lines in Best Corrected Visual Acuity [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Improvement in visual acuity compared to baseline values before transplant


Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562002

Locations
Spain
IOBA
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
Investigators
Principal Investigator: Margarita Calonge, MD, PhD Instituto Universitario de Oftalmobiología Aplicada
  More Information

No publications provided

Responsible Party: Instituto Universitario de Oftalmobiología Aplicada
ClinicalTrials.gov Identifier: NCT01562002     History of Changes
Other Study ID Numbers: IOBA-05-2010
Study First Received: March 22, 2012
Last Updated: March 18, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

Additional relevant MeSH terms:
Syndrome
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014