An Autologous Anti-Inflammatory Protein Solution Yielded a Favorable Safety Profile and Significant Pain Relief in an Open-Label Pilot Study of Patients with Osteoarthritis
| Autor: | Ryan Foreman, Mark Klaassen, Edith Cullen, William P. King, Jason Hix, Jennifer E. Woodell-May, Krista Toler |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
medicine.medical_specialty
medicine.drug_class Pain relief lcsh:Medicine intra-articular Osteoarthritis General Biochemistry Genetics and Molecular Biology Anti-inflammatory 03 medical and health sciences 0302 clinical medicine Degenerative disease IL-1ra Quality of life Internal medicine medicine Original Research Article lcsh:QH301-705.5 OA 030203 arthritis & rheumatology 030222 orthopedics business.industry AAI lcsh:R medicine.disease Protein solution Safety profile lcsh:Biology (General) Open label business APS |
| Zdroj: | BioResearch Open Access, Vol 6, Iss 1, Pp 151-158 (2017) BioResearch Open Access |
| ISSN: | 2164-7860 2164-7844 |
| Popis: | Osteoarthritis (OA) is a progressive and degenerative disease, which may result in significant pain and decreased quality of life. Recent updates in our understanding of OA have demonstrated that it is a whole joint disease that has many similarities to an unhealed wound containing inflammatory cytokines. The nSTRIDE Autologous Protein Solution (APS) Kit is a medical device under development for the treatment of OA. The APS Kit processes a patient's own blood at the point of care to contain high concentrations of anti-inflammatory cytokines and anabolic growth factors. This study assessed the safety and treatment effects of a single intra-articular injection of APS. Eleven patients were enrolled in this study. Sufficient blood could not be drawn from one patient who was subsequently withdrawn, leaving 10 patients treated. Minor adverse events (AEs) were experienced by seven subjects (63.6%). There was one serious AE (diverticulitis) unrelated to the device or procedure. One subject experienced AEs that were judged “likely” to be procedure related (arthralgia/musculoskeletal discomfort) and all resolved within 6 days of injection. All other AEs were unrelated to the device or procedure. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scores improved significantly over time (ANOVA, p |
| Databáze: | OpenAIRE |
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