
{"id":45897,"date":"2025-09-01T10:33:53","date_gmt":"2025-09-01T09:33:53","guid":{"rendered":"https:\/\/www.btitrainingcenter.com\/real-world-outcomes-of-allogeneic-immunosafe-plasma-rich-in-growth-factors-eye-drops-for-refractory-ocular-surface-diseases-a-prospective-observational-study\/"},"modified":"2026-02-06T12:20:17","modified_gmt":"2026-02-06T11:20:17","slug":"real-world-outcomes-of-allogeneic-immunosafe-plasma-rich-in-growth-factors-eye-drops-for-refractory-ocular-surface-diseases-a-prospective-observational-study","status":"publish","type":"post","link":"https:\/\/www.btitrainingcenter.com\/it\/real-world-outcomes-of-allogeneic-immunosafe-plasma-rich-in-growth-factors-eye-drops-for-refractory-ocular-surface-diseases-a-prospective-observational-study\/","title":{"rendered":"Real-World Outcomes of Allogeneic Immunosafe Plasma Rich in Growth Factors Eye Drops for Refractory Ocular Surface Diseases: A Prospective Observational Study"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row content_text_aligment=&#8221;left&#8221; row_background_lines=&#8221;no&#8221;][vc_column][vc_column_text css=&#8221;&#8221;]<\/p>\n<h3 class=\"title\">Abstract<\/h3>\n<div id=\"enc-abstract\" class=\"abstract-content selected\">\n<div id=\"enc-abstract\" class=\"abstract-content selected\">\n<p><strong class=\"sub-title\">Introduction:\u00a0<\/strong>Immunosafe plasma rich in growth factors eye drops (is-ePRGF) have shown anti-inflammatory and regenerative effects on ocular surface diseases (OSD). However, medical or technical issues may preclude some patients from undergoing autologous blood extraction. We aimed to evaluate the safety and clinical outcomes of allogeneic is-ePRGF therapy for refractory OSD in real-world practice.<\/p>\n<p><strong class=\"sub-title\">Methods:\u00a0<\/strong>A single-center cohort was conducted involving consecutive patients with severe OSD nonresponsive to conventional therapy. All participants received allogeneic is-ePRGF derived from healthy family donors as compassionate treatment (one drop four times daily for 6 weeks per cycle), with a minimum follow-up of 3 months. Primary outcomes included symptom changes assessed by Ocular Surface Disease Index (OSDI) and Symptom Assessment iN Dry Eye (SANDE) questionnaires, resolution of persistent epithelial defects (PED), and adverse events (AE). Secondary outcomes included best-corrected visual acuity (BCVA), intraocular pressure (IOP), corneal staining, Schirmer I test, tear break-up time (BUT), conjunctival bulbar redness, and meibomian gland dysfunction (MGD). Multilevel mixed-effects models were used to account for intra-patient and inter-eye correlations.<\/p>\n<p><strong class=\"sub-title\">Results:\u00a0<\/strong>A total of 30 patients (58 eyes; mean age 53.4 \u00b1 22.6 years; 50% female) were included. The most common diagnoses were severe dry eye disease and neurotrophic keratopathy, frequently associated with autoimmune\/inflammatory conditions. Overall, 12 patients (40%) had previously received autologous therapies. Donors were primarily first-degree relatives. Median follow-up was 9 months (range 3\u201230 months), with a mean of 6.2 \u00b1 3 cycles. OSDI and SANDE scores significantly improved (p &lt; 0.001). Among 12 cases with PED, 8 (67%) fully resolved. No AE occurred. BCVA (p = 0.010), Schirmer test, BUT, conjunctival bulbar redness, corneal staining, and MGD severity improved significantly (p &lt; 0.001); IOP remained stable (p = 0.132).<\/p>\n<p><strong class=\"sub-title\">Conclusions:\u00a0<\/strong>Allogeneic is-ePRGF was a safe and effective alternative for refractory OSD when autologous sources were not available or suitable. Standardization of regulatory frameworks for allogeneic blood-based therapies is needed to support broader clinical adoption.<\/p>\n<\/div>\n<p><strong class=\"sub-title\">Keywords:\u00a0<\/strong>Allogeneic blood-based eye drops; Dry eye disease; Hemoderivatives; Ocular surface disease; PRGF; Plasma rich in growth factors.<\/p>\n<\/div>\n<p>[\/vc_column_text][vc_empty_space][vc_column_text]<\/p>\n<h3>Figures<\/h3>\n<p>[\/vc_column_text][vc_empty_space][\/vc_column][\/vc_row][vc_row content_placement=&#8221;middle&#8221; content_text_aligment=&#8221;center&#8221;][vc_column]<div class=\"qodef-image-gallery qodef-grid-list qodef-disable-bottom-space  qodef-ig-grid-type qodef-four-columns qodef-tiny-space  qodef-image-behavior-lightbox\">\n\t<div class=\"qodef-ig-inner qodef-outer-space\">\n\t\t\t\t\t<div class=\"qodef-ig-image qodef-item-space\">\n\t\t\t\t<div class=\"qodef-ig-image-inner\">\n\t\t\t\t\t\t\t\t\t\t\t<a itemprop=\"image\" class=\"qodef-ig-lightbox\" href=\"https:\/\/www.btitrainingcenter.com\/wp-content\/uploads\/2021\/08\/40123_2025_1211_Fig1_HTML.jpg\" data-rel=\"prettyPhoto[image_gallery_pretty_photo-555]\" title=\"&lt;strong&gt;Figure 1.&lt;\/strong&gt; Allogeneic immunosafe plasma rich in growth factors eye drops (is-ePRGF) protocol. (a) Blood was collected into 9-mL tubes containing anticoagulant. (b) Samples were centrifuged at 580 g for 8 min at room temperature. (c) Then, the supernatant was collected using a closed system under a laminar flow hood. (d) It was activated with 10% calcium chloride (e) at 50 \u03bcL per 1 mL of plasma. (f) Next, the released plasma was incubated at 37 \u00b0C for 1 h, and (g) heat-treated at 56 \u00b0C for 60 min to reduce the immunologic components. (h) Finally, the treated plasma was filtered and (i) aliquoted in a single-use kit. (j) A sample of is-ePRGF was obtained for microbiological analysis control in each preparation. (k) A close-up view of an empty disposable kit, each containing 32 dispensers of 0.5 mL. This should be stored at \u221220 \u00b0C until use. (l) The dispenser in use can be kept in an individual container and stored at 4 \u00b0C for up to 72 h\">\n\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.btitrainingcenter.com\/wp-content\/uploads\/2021\/08\/40123_2025_1211_Fig1_HTML-200x200.jpg\" alt=\"\" width=\"200\" height=\"200\" \/>\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t\t\t\t<div class=\"qodef-ig-image qodef-item-space\">\n\t\t\t\t<div class=\"qodef-ig-image-inner\">\n\t\t\t\t\t\t\t\t\t\t\t<a itemprop=\"image\" class=\"qodef-ig-lightbox\" href=\"https:\/\/www.btitrainingcenter.com\/wp-content\/uploads\/2021\/08\/40123_2025_1211_Fig2_HTML.jpg\" data-rel=\"prettyPhoto[image_gallery_pretty_photo-555]\" title=\"&lt;strong&gt;Figure 2.&lt;\/strong&gt; Paired comparisons between baselines values and changes (\u0394) in BCVA, IOP, BUT, and Schirmer test following allogeneic is-ePRGF treatment. BCVA best-corrected visual acuity, IOP intraocular pressure, BUT break-up time, is-ePRGF immunosafe plasma rich in growth factors eye drops\">\n\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.btitrainingcenter.com\/wp-content\/uploads\/2021\/08\/40123_2025_1211_Fig2_HTML-200x200.jpg\" alt=\"\" width=\"200\" height=\"200\" \/>\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t\t\t\t<div class=\"qodef-ig-image qodef-item-space\">\n\t\t\t\t<div class=\"qodef-ig-image-inner\">\n\t\t\t\t\t\t\t\t\t\t\t<a itemprop=\"image\" class=\"qodef-ig-lightbox\" href=\"https:\/\/www.btitrainingcenter.com\/wp-content\/uploads\/2021\/08\/40123_2025_1211_Fig3_HTML.jpg\" data-rel=\"prettyPhoto[image_gallery_pretty_photo-555]\" title=\"&lt;strong&gt;Figure 3.&lt;\/strong&gt; Changes in clinical grading scores following allogeneic immunosafe plasma rich in growth factors eye drops treatment\">\n\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.btitrainingcenter.com\/wp-content\/uploads\/2021\/08\/40123_2025_1211_Fig3_HTML-200x200.jpg\" alt=\"\" width=\"200\" height=\"200\" \/>\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t\t\t\t<div class=\"qodef-ig-image qodef-item-space\">\n\t\t\t\t<div class=\"qodef-ig-image-inner\">\n\t\t\t\t\t\t\t\t\t\t\t<a itemprop=\"image\" class=\"qodef-ig-lightbox\" href=\"https:\/\/www.btitrainingcenter.com\/wp-content\/uploads\/2021\/08\/40123_2025_1211_Fig4_HTML.jpg\" data-rel=\"prettyPhoto[image_gallery_pretty_photo-555]\" title=\"&lt;strong&gt;Figure 4.&lt;\/strong&gt; Representative slit-lamp clinical photographs of patients before (a, c, e) and after (b, d, f) treatment with allogeneic immunosafe plasma rich in growth factors eye drops. The first case (a, b) shows a marked reduction in corneal fluorescein staining, while the second (c, d) and third (e, f) cases demonstrated resolution of persisted corneal epithelial defects Similar articles The Comparison between the Composition of 100% Autologous Serum and 100% Platelet-Rich Plasma Eye Drops and Their Impact on the Treatment Effectiveness of Dry Eye Disease in Primary Sjogren Syndrome. Wr\u00f3bel-Dudzi\u0144ska D, Przekora A, Kazimierczak P, \u0106wikli\u0144ska-Haszcz A, Kosior-Jarecka E, \u017barnowski T. J Clin Med. 2023 Apr 25;12(9):3126. doi: 10.3390\/jcm12093126. PMID: 37176566Free PMC article. Neurotrophic Keratitis. Gurnani B, Feroze KB, Patel BC. 2025 Mar 27. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan\u2013. PMID: 28613758Free Books &#038; Documents. Adjunct Topical Human Immunoglobulin IgG Therapy in Dry Eye Disease. Vanathi M, Khan L, Velpandian T, Dubey A, Gupta N, Seth T, Mahapatra M, Khan MA, Jain S, Tandon R. Indian J Ophthalmol. 2025 Apr 1;73(4):610-620. doi: 10.4103\/IJO.IJO_608_25. Epub 2025 Mar 27.\">\n\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.btitrainingcenter.com\/wp-content\/uploads\/2021\/08\/40123_2025_1211_Fig4_HTML-200x200.jpg\" alt=\"\" width=\"200\" height=\"200\" \/>\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t\t<\/div>\n<\/div>[vc_empty_space height=&#8221;50px&#8221;][\/vc_column][\/vc_row][vc_row][vc_column]<a itemprop=\"url\" href=\"https:\/\/www.btitrainingcenter.com\/wp-content\/uploads\/2021\/08\/01.-opta_40123_2025_Article_1211.pdf\" target=\"_blank\"  class=\"qodef-btn qodef-btn-medium qodef-btn-solid btnWebRosa2\"  >\n    <span class=\"qodef-btn-text\">Scarica articolo<\/span>\n    <\/a>[\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p><strong>Ophthalmol Ther. 2025 Sep;14(9):2253-2281.<\/strong><br \/>\nImmunosafe plasma rich in growth factors eye drops (is-ePRGF) have shown anti-inflammatory and regenerative effects on ocular surface diseases (OSD). However, medical or technical issues may preclude some patients from undergoing autologous blood extraction. We aimed to evaluate the safety and clinical outcomes of allogeneic is-ePRGF therapy for refractory OSD in real-world practice.<\/p>\n","protected":false},"author":2002,"featured_media":45854,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[157],"tags":[],"class_list":["post-45897","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicina-rigenerativa"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.btitrainingcenter.com\/it\/wp-json\/wp\/v2\/posts\/45897","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.btitrainingcenter.com\/it\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.btitrainingcenter.com\/it\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.btitrainingcenter.com\/it\/wp-json\/wp\/v2\/users\/2002"}],"replies":[{"embeddable":true,"href":"https:\/\/www.btitrainingcenter.com\/it\/wp-json\/wp\/v2\/comments?post=45897"}],"version-history":[{"count":1,"href":"https:\/\/www.btitrainingcenter.com\/it\/wp-json\/wp\/v2\/posts\/45897\/revisions"}],"predecessor-version":[{"id":45898,"href":"https:\/\/www.btitrainingcenter.com\/it\/wp-json\/wp\/v2\/posts\/45897\/revisions\/45898"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.btitrainingcenter.com\/it\/wp-json\/wp\/v2\/media\/45854"}],"wp:attachment":[{"href":"https:\/\/www.btitrainingcenter.com\/it\/wp-json\/wp\/v2\/media?parent=45897"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.btitrainingcenter.com\/it\/wp-json\/wp\/v2\/categories?post=45897"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.btitrainingcenter.com\/it\/wp-json\/wp\/v2\/tags?post=45897"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}