Safety Study of Stem Cell Transplant to Treat Limbus Insufficiency Syndrome

Limbus Corneae Insufficiency Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562002
• Other study ID #: IOBA-05-2010
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 22, 2012
• Last updated: January 7, 2015
• Start date: March 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Instituto Universitario de Oftalmobiología Aplicada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Limbus Corneae Insufficiency Syndrome
• Syndrome

Intervention

Procedure:
• Stem Cell with Amniotic Membrane Transplant
Single stem cell expansion in amniotic membrane transplant

Locations

Country	Name	City	State
Spain	IOBA	Valladolid

Sponsors (4)

Lead Sponsor	Collaborator
Instituto Universitario de Oftalmobiología Aplicada	Centro en Red de Medicina Regenerativa de Castilla y Leon, Red de Terapia Celular, University of Valladolid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viability and safety of mesenchymal stem cell transplant	Absence of cell metaplasia with phenotype different to corneal or conjunctival as expected, confirmed by corneal impression cytology and in vivo confocal laser ophthalmoscopy	1 Year	Yes
Secondary	Absence of complications in pre and peri surgical implantation	Correct handling and implantation of stem cell with amniotic membrane transplant following an 4 step classification.	1 Week	Yes
Secondary	Improvement of 2 lines in Best Corrected Visual Acuity	Improvement in visual acuity compared to baseline values before transplant	12 month	No