Autologous Serum Obtained by a Closed-Circuit Collection Device

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGIANCARLO FATOBENE

About this trial

Autologous serum eye drops (ASED) are an established therapy for ocular surface diseases; however, their preparation can be costly and may not be available due to the need for germ-free conditions. This pilot trial assesses the feasibility of collecting ASED in a closed-circuit system for patients with chronic ocular surface diseases.

Eligibility criteria

Qualifiers

≥ 18 years

Dry eye and/or chronic epithelial defects of the ocular surface with indication for autologous serum according to the evaluation of ophthalmologists specialized in Cornea and Ocular Surface;

Peripheral venous access or PICC that allows the collection of whole blood.

Disqualifiers

Active ocular infection;

Hemoglobin < 11 g/dL;

Angina, MI, or stroke in the last 30 days;

Significant pulmonary or cardiac disease that contraindicates autologous serum collection in the investigator's opinion;

Trial design

Treatments tested in this trial

  • Autologous Serum 20%

Treatment groups

16 Participants
are divided into 1 treatment group

Sponsors and collaborators

GIANCARLO FATOBENE

Lead sponsor

University of Sao Paulo General Hospital

Sponsor institution

JP Farma

Collaborator