{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T16:26:43Z","timestamp":1792168003807,"version":"4.4.0"},"reference-count":57,"publisher":"MDPI AG","issue":"17","license":[{"start":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T00:00:00Z","timestamp":1787443200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"crossref","award":["1R41AI120546-01"],"award-info":[{"award-number":["1R41AI120546-01"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Int. J. Mol. Sci.","IJMS"],"abstract":"<jats:p>Ionizing radiation (IR) damage, whether intentional, accidental, or therapeutic, reverberates throughout the body. The FDA has approved the use of palliative care and leukocyte growth factors for hematologic depletion (H-ARS), but no treatments have been approved for gastrointestinal damage (GI-ARS). Synthetic PIF (sPIF) safely replicates endogenous PIF\u2019s preventative, reparatory, and regenerative effects. Specifically relevant for radiation-induced damage, sPIF reduces oxidative stress. Subcutaneous (SC) sPIF prevents LD100\/30 mortality at 2 w post-treatment and restores GI function post-6Gy exposure (in mice). Daily SC sPIF for 14 d, starting 24 h post-LD85\/40 (7.17 Gy) total-body \u0263-irradiation (TBI), increases survival 2.76-fold (14.7% (5\/34) to 40.7% (24\/59); p = 0.0036) by 4 w post-therapy. All sPIF-treated mice survived for the first 10 d, while only 80% survived in the sham group (p = 0.0034). The sPIF-treated group reached 50% survival at 23 di, while this figure was reached at 19 d in the sham-treated group, with a 21% delay. Importantly, sPIF delays weight loss for up to 25 d, increasing weight by ~12% above baseline and improving colon architecture; in the sham, both weight and colon recovery failed. sPIF partially prevents declines in hemoglobin and platelets, with no bleeding\/sepsis observed, while WBC counts declined. sPIF\u2019s safety and lack of deleterious drug-to-drug interaction were documented in a First-in-Human, FDA-approved clinical trial for autoimmune disease. Chronic FDA-guided toxicology\/toxicokinetic studies demonstrated NOAEL and the highest safety margin. Collectively, sPIF safely and significantly increases survival, weight gain, and colon crypt scale, directly supporting its suitability for FDA-ARS animal-rule approval.<\/jats:p>","DOI":"10.3390\/ijms27177548","type":"journal-article","created":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T11:47:19Z","timestamp":1787572039000},"page":"7548","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Synthetic Preimplantation Factor (sPIF)* Improves Survival and GI Function in Acute Lethal Radiation Syndrome in a Clinically Relevant Murine Model"],"prefix":"10.3390","volume":"27","author":[{"given":"Roberto","family":"Calix","sequence":"first","affiliation":[{"name":"Section of Maternal Fetal Medicine, Department of Obstetrics, Gynecology & Reproductive Sciences, Yale School of Medicine, 333 Cedar Street, FMB 329, P.O. Box 208063, New Haven, CT 06520-8063, USA"},{"name":"Maternal and Fetal Medicine, Ochsner Health, 2700 Napoleon Ave. 4th Floor, New Orleans, LA 70115, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean H.","family":"Wilson","sequence":"additional","affiliation":[{"name":"Yale Women and Children\u2019s Center for Blood Disorders and Preeclampsia Advancement, Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine, 310 Cedar Street, FMB 220, New Haven, CT 06520-8063, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5594-0532","authenticated-orcid":false,"given":"Martin","family":"Mueller","sequence":"additional","affiliation":[{"name":"Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine, 333 Cedar Street, FMB 337A, New Haven, CT 06520-8063, USA"},{"name":"Institute of Biochemistry and Molecular Medicine, University of Bern, 3010 Bern, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4525-5560","authenticated-orcid":false,"given":"Peter M.","family":"Glazer","sequence":"additional","affiliation":[{"name":"Department of Therapeutic Radiology, Yale School of Medicine, P.O. Box 208040, New Haven, CT 06520-8040, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0711-8688","authenticated-orcid":false,"given":"Daniel","family":"Zelterman","sequence":"additional","affiliation":[{"name":"Yale School of Public Health, 60 College Street, P.O. Box 208034, New Haven, CT 06510-3201, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle","family":"Deveaux","sequence":"additional","affiliation":[{"name":"Yale School of Public Health, 60 College Street, P.O. Box 208034, New Haven, CT 06510-3201, USA"},{"name":"Department of Early Clinical Development, Regeneron Pharmaceuticals, Tarrytown, NY 10591-6717, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1181-3544","authenticated-orcid":false,"given":"Caroline","family":"Zeiss","sequence":"additional","affiliation":[{"name":"Department of Comparative Medicine, Yale School of Medicine, P.O. Box 208016, New Haven, CT 06520-8016, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-2115-7860","authenticated-orcid":false,"given":"Arumugam R.","family":"Jayakumar","sequence":"additional","affiliation":[{"name":"Tamer Family Department of Obstetrics, Gynecology, and Reproductive Sciences, Miller School of Medicine, University of Miami, 1120 NW 14th Street, Suite # 1154, Miami, FL 33136-2107, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eytan R.","family":"Barnea","sequence":"additional","affiliation":[{"name":"Tamer Family Department of Obstetrics, Gynecology, and Reproductive Sciences, Miller School of Medicine, University of Miami, 1120 NW 14th Street, Suite # 1154, Miami, FL 33136-2107, USA"},{"name":"BioIncept, LLC (*sPIF Proprietary), New York, NY 10016-1701, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael J.","family":"Paidas","sequence":"additional","affiliation":[{"name":"Yale Women and Children\u2019s Center for Blood Disorders and Preeclampsia Advancement, Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine, 310 Cedar Street, FMB 220, New Haven, CT 06520-8063, USA"},{"name":"Tamer Family Department of Obstetrics, Gynecology, and Reproductive Sciences, Miller School of Medicine, University of Miami, 1120 NW 14th Street, Suite # 1154, Miami, FL 33136-2107, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,8,23]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"24","DOI":"10.1016\/j.exphem.2007.01.008","article-title":"Accidental or intentional exposure to ionizing radiation: Biodosimetry and treatment options","volume":"35","author":"Chao","year":"2007","journal-title":"Exp. 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