Allogeneic Immunosafe Plasma Rich In Growth Factors Eye Drops From Healthy Donors As An Alternative Therapy In Cases With Refractory Ocular Surface Disorders

Blood-derived products were extensively implemented in different clinical areas of medicine as a regenerative therapy for severe cases. Immunosafe plasma rich in growth factors eye drops (is-ePRGF) is a well-known autologous blood-derived therapy manufactured through a standardized method with an evidence-based anti-inflammatory and regenerative role in ocular surface disorders (OSD); moreover, currently, we have preclinical evidence that is-ePRGF has a higher biological potential than autologous serum or topical insulin. However, not all patients that needed can be donors due age, systemic conditions, or technical issues for blood extraction. We aimed to report the clinical outcomes of is-ePRGF from allogeneic source for refractory OSD.

Instituto Universitario Fernández-Vega, Oviedo, Spain.

Medical records from patients diagnosed with severe OSD non-responsive to conventional therapy, who were given allogeneic is-ePRGF as compassionate treatment, were reviewed. Donors were healthy family members who were screened using standard test used in blood bank screening to check for blood-borne diseases. Informed consents were obtained from patients and donors, and protocol was approved (CEImPA 2023.281).Ocular Surface Disease Index (OSDI) questionnaire and Visual Analogue Score (VAS), best-corrected visual acuity (BCVA), intraocular pressure (IOP), corneal fluorescein staining, Schirmer I test, tear break-up time (BUT) and conjunctival bulbar redness were recorded. Adverse events were also assessed. Linear mixed models were used.

Thirty-five eyes from 18 patients with a mean age of 53.5±23.7 years (range:11-90) were included; half of them were female. Offspring were the donors in half of cases. Blood dyscrasia and autoimmune diseases, and severe dry eye disease and neurotrophic keratitis were the most common systemic and ocular conditions, respectively. 7 (39%) cases had already been treated with autologous therapy. Over a mean 2-year follow-up period (range: 0.5–5 years), OSDI, VAS, BCVA, corneal fluorescein staining, conjunctival bulbar redness, Schirmer I test, and BUT improved from the baseline values (p<0.05), while IOP remained unchanged. No adverse effects were recorded during the follow-up period. 

Allogeneic is-ePRGF seems to be an effective and safe alternative treatment for patients with refractory OSD in selected cases where autologous blood extraction is unavailable or unsuitable. Allogeneic source for blood-based therapy may not only improve the biological properties, allow for better quality control and efficient processing, but broaden the availability of this regenerative therapy for challenging cases. Further larger and controlled studies are still needed to confirm these results.