Safety Study of Stem Cell Transplant to Treat Limbus Insufficiency Syndrome

Sponsor

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA (Other)

Overall Status

Completed

CT.gov ID

NCT01562002

Collaborator

University of Valladolid (Other), Centro en Red de Medicina Regenerativa de Castilla y Leon (Other), Red de Terapia Celular (Industry)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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

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 :

Mar 1, 2012

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 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

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

Viability and safety of mesenchymal stem cell transplant [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

Absence of complications in pre and peri surgical implantation [1 Week]
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 [12 month]
Improvement in visual acuity compared to baseline values before transplant

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	IOBA	Valladolid		Spain	47011

Sponsors and Collaborators

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
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 (Institute of Applied Ophthalmobiology) - IOBA