The Effect of Cord Blood Serum Eyes Drops Administer in Patients With Severe Keratopathy Related to EGFR-I Treatment

Personalized Approach in the Treatment of Patients Affected by Severe Dry Eye Associated With Therapy With EGFR Inhibitors (EGRFR-I) With Growth Factors in Cord Blood Serum (CBS) Eye Drops

The study aim to evaluate the efficacy of cord blood eye drops in the healing of the damaged corneal epithelium.

Study Overview

• Status: Recruiting
• Conditions: Dry Eye
• Intervention / Treatment: Drug: administration cord blood based eye drops, standardized to the deliver BDNF.

Detailed Description

Patients undergoing treatment with EGFR inhibitor for lung cancer might develop corneal damage.

The study aims to evaluate the healing of corneal epithelium by administering cord blood eye drops for one month.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luigi Fontana, MD; Phone Number: +390512142837; Email: luigi.fontana6@unibo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    • Contact: Luigi Fontana, MD; Phone Number: +390512142837; Email: luigi.fontana6@unibo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age over 18 years
• oncology and advanced cancer patients who have EGFr mutation and who require treatment with antiEGFr drugs
• signing of informed consent

Exclusion Criteria:

• Patients who are unable to store/administer the CSCO independently, or with the help of care-givers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eye drops derived from cordonal blood serum; patients who are given eye drops	Drug: administration cord blood based eye drops, standardized to the deliver BDNF.; administration cord blood based eye drops customized to deliver epitelio tropic factors, incluiding EGF in EGFR blocked cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal damage measured with National Eye Institute (NEI) score	Evaluation of the effect of cord blood eye drops administration on the variation of corneal damage in patients with severe keratopathy	one week before the start of treatment and thirty days after the end of treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in discomfort	Symptomatology assessment with OSDI questionnaire. Quality of life analysis with Health-related SF-12 questionnaire, and SEI-QoL subjects' quality of life scale.	one week before the start of treatment and thirty days after the end of treatment.
Change in quality of life	Change in QOL measured by SF-12 questionnaire	one week before the start of treatment and thirty days after the end of treatment.
Change in quality of life	Change in QOL measured by SEI-QoL questionnaire	one week before the start of treatment and thirty days after the end of treatment.

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Luigi Fontana, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: February 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: OFTAFONTANA_DED_EGFR-I; F35F22000080001 (Other Grant/Funding Number: Ministry of Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No