CORD BLOOD SERUM IN THE TREATMENT OF OCULAR SURFACE DISEASES (PILOT STUDY.) - OFTACAMPOS_08_01

• Conditions: severe ocular surface disorders and the enhancement of corneal wound healing; MedDRA version: 9.1Level: HLTClassification code 10011049Term: Corneal structural change, deposit and degeneration

• Registration Number: EUCTR2008-005757-38-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

age > 18 years
to suffer from GVHD after bone marrow transplantation or SS-I
presence of permanent or transient corneal epithelial defects scored > 2 , according to DEWS severity classification
to be in a general healthy condition
signement of study consense for participation and personal data treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

to suffer from glaucoma and being under treatment with antiglaucomatous drugs
to have received refractive surgery over the past year

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Human autologous serum (AS) eye drops have been successfully used in the treatment of severe ocular surface disorders and the enhancement of corneal wound healing,, due to their growth factor (GF) content. Umbilical cord serum (UCS) contains even higher GF concentrations and the objective of the study was to prove whether UCS eye drops<br>1.are effective in the healing of corneal epithelial defects. <br>2.ameliorate the painful subjective symptoms;Secondary Objective: improving of the painful subjective symptoms;Primary end point(s): : UCS eye drops efficacy in the healing of corneal epithelial defects in GVHD (Graft Versus Host Disease) and primary Sjogren?s Syndrome (SS-I) patients, evaluated after two and four weeks of treatment .