Comparative Effects of Autologous Serum, Umbilical Cord Blood-Derived Drops, and Platelet Lysate on Ocular Surface Parameters

Summary

In this study, patients are randomly assigned to the study groups (autologous peripheral blood, umbilical cord blood, autologous serum). Each patient, who wishes to undergo any treatment, has the right to be informed about their disease and the recommended treatment by the treating physician so that they can decide whether to proceed with it or not.

During the study, you will need to complete an eye symptom assessment questionnaire (Ocular Surface Disease Index - OSDI).

Conditions

• Dry Eye Disease (DED)

Interventions

BIOLOGICAL

Autologous serum eyedrops

For Autologous Serum preparation, 50 ml of peripheral blood were collected and centrifuged at 4000 g at +8°C for 15 minutes. A total of 3.5 ml of saline from preservative free eye drops was replaced with 3.5 ml of autologous serum. Infectious disease screening matched that of the PL group. Final products were stored for one week at +4°C and up to four weeks at -20°C.

BIOLOGICAL

Autologous Platelet Lysate

Fifty milliliters of peripheral blood were collected in anticoagulated tubes and centrifuged at 900 g for 10 minutes to isolate platelet rich plasma (PRP). PRP was diluted to 30% (v/v) with sterile saline, frozen at -80°C for at least 60 minutes (thermal shock), and rapidly thawed at 4°C to induce platelet lysis. The resulting PL was aliquoted into sterile containers and stored at -20°C for approximately 45 days. On the day of use, vials were thawed at 4°C. After production, the eye drops were placed in sterile 5 ml and 10 ml containers with a dropper tip

BIOLOGICAL

Umbilical Cord Blood Platelet Lysate

CB derived PL was produced based on the PL production process according to the already published protocol of the Hellenic Cord Blood Bank (HCBB) using cord blood units from full term pregnancies (38-40 weeks) that were unsuitable for transplantation according to the criteria of the World Accreditation Organization "FACT-NetCord" but donated for research with informed consent which was obtained prior to delivery and was in accordance with the National Bioethics Committee according to Helsinki declaration. PRP was isolated via double centrifugation, frozen at -80°C for at least 24 hours, and rapidly thawed at 37°C to release platelet derived growth factors. The lysate was filtered through a 0.22 μm non pyrogenic filter and aliquoted into 5-10 ml vials. Up to 10 ml of PL were obtained per cord blood unit. CB eye drops were stored at -20°C for up to 30 days without measurable loss of growth factor content.

Sponsors & Collaborators

• Biomedical Research Foundation of the Academy of Athens

  collaborator UNKNOWN

• G.Gennimatas General Hospital

  lead OTHER

Principal Investigators

• Konstantinos Droutsas, Associate Professor Ophthalmol · 1st Department of Ophthalmology at the G. Gennimatas General Hospital in Athens, Greece

• Georgios Kymionis, Professor in Ophthalmology · 1st Department of Ophthalmology at the G. Gennimatas General Hospital in Athens, Greece

• Dimitris Papaconstantinou, Professor in Ophthalmology · 1st Department of Ophthalmology at the G. Gennimatas General Hospital in Athens, Greece

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-17

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• Greece

Study Locations