Regenerative Medicine in Ocular Surface: Application of Cell Therapy for Ocular Surface Repair Using Progenitor Cells of Sclerocorneal Limbus Amplified ex Vivo

Unilateral Limbic Insufficiency Clinical Trial

— MeRSO09  

Official title:

Regenerative Medicine in Ocular Surface: Application of Cell Therapy for Ocular Surface Repair Using Progenitor Autologous Cells of Sclerocorneal Limbus Amplified ex Vivo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01470573
• Other study ID #: MeRSO09
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2011
• Last updated: December 7, 2012
• Start date: November 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

Progenitor limbo sclerocorneal cells have properties of proliferation and differentiation to corneal and conjunctival epithelium. This cells can be isolated and ex vivo expanded using cell culture technics that could permit the biological replacement of damaged ocular surface.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

principal Inclusion Criteria:

• Serious unilateral limbic insufficiency

• Normal ophthalmological clinical examination in the opposite eye (biopsied eye)

Exclusion Criteria:

• one-eyed

• serious disorders in palpebral dynamics

• bilateral limbic insufficiency, immunological, systemic or local illness like toxical epidermic necrosis or pemphigoid

• breastfeeding or pregnancy

• positive serology of HIV, VLTH, HVC, HVB, CMV, Trypanosoma Cruzi or Treponema Pallidum

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Unilateral Limbic Insufficiency

Intervention

Procedure:
• biological replacement corneal surface
the expanded tissue will be applied to patient to replace the damaged ocular surface

Locations

Country	Name	City	State
Spain	Hospital Clinic of Barcelona	Barcelona
Spain	Instituto de Microcirugía Ocular	Barcelona
Spain	Instituto Universitario Barraquer	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Clinic per a la Recerca Biomédica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	visual acuity improvement	6 months	No
Secondary	Improvement in appearance of ocular surface	presence of corneal epithelium de novo	6 months	No
Secondary	lack of scar tissue in ocular surface		6 months	No
Secondary	decrease of preexisting corneal vascularization		6 months	No
Secondary	Improvement of corneal transparency		6 months	No
Secondary	absence or decrease of corneal conjunctivalization	the amount of caliciform cells using impression cytology will be compare between screening and 6 months visit	6 months	No
Secondary	adverse events		6 months	Yes