Limited · human
This observational study investigated the relationship between serum Thymosin β4 (Tβ4) levels and Kawasaki disease (KD) in children, with a specific focus on coronary artery lesions (CALs). Researchers measured serum Tβ4 concentrations via ELISA in children diagnosed with KD and age-matched healthy controls, further subdividing the KD group into those with and without CALs. The study found that serum Tβ4 levels were significantly lower in children with KD compared to healthy controls, and were reduced even further in KD patients who developed CALs. Following intravenous immunoglobulin (IVIG) treatment, Tβ4 levels increased significantly. Correlation analyses revealed negative associations between Tβ4 and several cytokines, including pro-inflammatory markers (TNF-α, IL-1β) and anti-inflammatory markers (IL-4, IL-10). The authors suggest that Tβ4 may play a role in KD's inflammatory pathogenesis and the progression of coronary artery involvement, proposing it as a potential diagnostic or therapeutic target. Key limitations include the observational design, which precludes causal inference, the pediatric-specific and single-condition focus, and the reliance on serum biomarker associations without mechanistic validation in this population.
Journal of inflammation research · Jul 2025DOI ↗ Limited · humanPreprint
This observational study examined the relationship between salivary oxidized forms of thymosin β4 (Tβ4) and thymosin β10 (Tβ10) and oxidative stress-related diseases in preterm infants born before 30 weeks of gestation. Researchers collected 149 saliva samples from 18 infants and analyzed the intact salivary proteome using nano-HPLC-ESI-MS, with relative quantification based on extracted ion current (XIC) peak area. The study found that post-menstrual age correlated significantly with total Tβ4, oxidized Tβ4 percentage, and total Tβ10. Higher fraction of inspired oxygen (FiO₂) values were associated with lower levels and percentages of oxidized Tβ10. Thymosin levels did not differ between infants with or without retinopathy of prematurity; however, higher oxidized Tβ10 levels were observed in infants who did not develop bronchopulmonary dysplasia (BPD), leading the authors to suggest a possible protective role for oxidized Tβ10 in inflammation and tissue repair. Key limitations include the very small sample size (18 infants), observational design, and the inability to establish causality. The authors propose saliva as a non-invasive matrix for future monitoring of oxidative stress in neonates.
Unknown journal · May 2025DOI ↗ Limited · human
This study investigated the role of CCN5, a matricellular protein, in preventing vascular restenosis after stent implantation (in-stent restenosis, ISR). Using RNA sequencing of stent-implanted porcine coronary arteries and single-cell RNA sequencing of mouse femoral artery injury models, the researchers found that CCN5 expression was reduced in vascular smooth muscle cells (VSMCs) following injury but elevated in regenerating endothelial cells (ECs). In ISR patients, plasma CCN5 levels were significantly lower and correlated inversely with restenosis severity. Using cell-type-specific loss- and gain-of-function mouse models, the study found that EC- and VSMC-specific deletion of CCN5 worsened neointimal hyperplasia, while CCN5 overexpression was protective. Mechanistically, CCN5 was found to interact with thymosin β4 (Tβ4) in ECs, promoting endothelial repair via the cleavage product Ac-SDKP, and also interacted with CD9 to support EC recovery. A CCN5 recombinant protein (CCN5rp)-coated stent deployed in a porcine model significantly increased endothelial strut coverage and reduced neointimal formation. Limitations include the translational gap between animal models and humans, and the observational nature of the patient plasma data.
European heart journal · May 2025DOI ↗ 🧪 TrialLimited · human
Registered Phase 3 interventional trial (completed), with sponsor-posted results. The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.
ClinicalTrials.gov · Nov 2016View trial ↗ 🧪 TrialLimited · human
Registered Phase 2 interventional trial (completed), with sponsor-posted results. Severe dry eye is a debilitating ocular disease resulting in loss of vision, reduced day-to-day function and significant discomfort. Tear substitutes are an important part of the treatment of all patients, however, even with aggressive us, the corneal(ocular)surface often remains very irregular due to poor surface healing. The agent being evaluated in this study, Thymosin Beta 4, promotes healing of the corneal surface and has been studied in patients with recalcitrant corneal ulcers and erosions with significant
ClinicalTrials.gov · Jul 2011View trial ↗ 🧪 TrialLimited · human
Registered Phase 2 interventional trial (completed), with sponsor-posted results. Thymosin Beta 4 (Tβ4) is a synthetic copy of the naturally-occurring 43-amino acid peptide that is found in a variety of tissues. Tβ4 promotes/accelerates wound repair in dermal, ocular, and cardiac animal models. Two recent pre-clinical evaluations have demonstrated that Tβ4 promotes corneal ocular surface defects healing in animal models of dry eye. RGN-259 (formulation of Tβ4 ophthalmic solution) mechanism of action offers potential to be a product that meets a major unmet medical need in patients with dry eye
ClinicalTrials.gov · Jul 2011View trial ↗ 🧪 TrialLimited · human
Registered Phase 2 interventional trial (terminated), with sponsor-posted results. As a consequence of damage to multiple organ systems throughout the course of their disease, diabetic patients suffer a number of chronic complications giving rise to increased morbidity, mortality, and health care costs specific to this population. Within the ophthalmic domain, diabetic retinopathy (DR) frequently induces serious visual impairment. Although DR can be addressed surgically, surgery remains a less than ideal intervention within this population with a well-characterized compromised ability to heal.
ClinicalTrials.gov · Jan 2008View trial ↗