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Professional Title: “Cibinetide Activates the Innate Repair Receptor to Induce Corneal Nerve Fiber Regeneration and Alleviate Neuropathic Pain Parameters: A Double-Blind Human Trial”
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Journal Context: Diabetes Care (American Diabetes Association) / PubMed | Identifiers: DOI: 10.2337/dc16-1129 / PMID: 27613734
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Principal Investigators: Brines, M., Dunne, A. N., van Velzen, M., Dahan, A., et al. (Leiden University Medical Center, Netherlands / Araim Pharmaceuticals)
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Methodology: A 28-day, randomized, double-blind, placebo-controlled human trial enrolling 64 adult patients diagnosed with sarcoidosis-associated small fiber neuropathy. Participants received daily subcutaneous injections of either a placebo or ARA-290 ($1\text{ mg}$ or $4\text{ mg}$). Corneal confocal microscopy was utilized to capture real-time physical changes in thin nerve structures (Brines et al., 2016).
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Key Findings: Patients receiving the $4\text{ mg}$ daily dose of ARA-290 experienced a statistically significant regrowth and regeneration of small nerve fibers (measured via corneal nerve fiber density) compared to the placebo cohort. This physical structural repair directly correlated with a substantial reduction in chronic neuropathic pain scores and a marked improvement in the subjects’ daily quality of life, without any adverse alterations to hemoglobin or red blood cell counts (Brines et al., 2016).
