PMID- 29279807
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201001
IS  - 2164-7844 (Print)
IS  - 2164-7860 (Electronic)
IS  - 2164-7844 (Linking)
VI  - 6
IP  - 1
DP  - 2017
TI  - 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.
PG  - 151-158
LID - 10.1089/biores.2017.0027 [doi]
AB  - 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      who was subsequently withdrawn, leaving 10 patients treated.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 < 0.0001, 12.0 +/- 1.2 preinjection, 3.3 +/- 2.9 one year postinjection, and 72.5% 
      WOMAC pain improvement). There was significant positive correlation between white 
      blood cell concentration in APS and improvement in WOMAC pain scores.
FAU - Hix, Jason
AU  - Hix J
AD  - Orthopedic Sports Medicine Center, Elkhart, Indiana.
FAU - Klaassen, Mark
AU  - Klaassen M
AD  - Orthopedic Sports Medicine Center, Elkhart, Indiana.
FAU - Foreman, Ryan
AU  - Foreman R
AD  - Orthopedic Sports Medicine Center, Elkhart, Indiana.
FAU - Cullen, Edith
AU  - Cullen E
AD  - Orthopedic Sports Medicine Center, Elkhart, Indiana.
FAU - Toler, Krista
AU  - Toler K
AD  - Zimmer Biomet, Warsaw, Indiana.
FAU - King, William
AU  - King W
AD  - Zimmer Biomet, Warsaw, Indiana.
FAU - Woodell-May, Jennifer
AU  - Woodell-May J
AD  - Zimmer Biomet, Warsaw, Indiana.
LA  - eng
PT  - Journal Article
DEP - 20171201
PL  - United States
TA  - Biores Open Access
JT  - BioResearch open access
JID - 101579333
PMC - PMC5738995
OTO - NOTNLM
OT  - AAI
OT  - APS
OT  - IL-1ra
OT  - OA
OT  - intra-articular
COIS- W.J.K., K.T., and J.W.M. are employees of Zimmer Biomet. M.K. has been a 
      consultant for Zimmer Biomet.
EDAT- 2017/12/28 06:00
MHDA- 2017/12/28 06:01
PMCR- 2017/12/01
CRDT- 2017/12/28 06:00
PHST- 2017/12/28 06:00 [entrez]
PHST- 2017/12/28 06:00 [pubmed]
PHST- 2017/12/28 06:01 [medline]
PHST- 2017/12/01 00:00 [pmc-release]
AID - 10.1089/biores.2017.0027 [pii]
AID - 10.1089/biores.2017.0027 [doi]
PST - epublish
SO  - Biores Open Access. 2017 Dec 1;6(1):151-158. doi: 10.1089/biores.2017.0027. 
      eCollection 2017.