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

NCT06830551 | Recruiting

• 2 other identifiers: OFTAFONTANA_DED_EGFR-IF35F22000080001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in discomfort

  one week before the start of treatment and thirty days after the end of treatment.

• Change in quality of life

  one week before the start of treatment and thirty days after the end of treatment.

• Change in quality of life

  one week before the start of treatment and thirty days after the end of treatment.

Study Arms (1)

eye drops derived from cordonal blood serum

EXPERIMENTAL

patients who are given eye drops

Drug: administration cord blood based eye drops, standardized to the deliver BDNF.

Interventions

administration cord blood based eye drops, standardized to the deliver BDNF. DRUG

administration cord blood based eye drops customized to deliver epitelio tropic factors, incluiding EGF in EGFR blocked cells

eye drops derived from cordonal blood serum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Luigi Fontana, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi Fontana, MD

CONTACT

+390512142837; luigi.fontana6@unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: February 17, 2025
• Study Start: September 12, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 17, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)