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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005757-38-IT

Enrollment

Registered

2009-03-03

Start date

2009-02-10

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Pharmaceutical Form: Eye drops, solution Current Sponsor code: siero dal sangue cordonale Concentration unit: pg picogram(s) Concentration type: equal Concentration number: 28-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 1.are effective in the healing of corneal epithelial defects. 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 .	—

Measure

Time frame

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 1.are effective in the healing of corneal epithelial defects. 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 .

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026