title: Polymerized-type I collagen downregulates inflammation and improves clinical outcomes in patients with symptomatic knee osteoarthritis following arthroscopic lavage: a randomized, double-blind, and placebo-controlled clinical trial.
abstract: OBJECTIVE
  Polymerized-type I collagen (polymerized collagen) is a downmodulator of inflammation and cartilage regenerator biodrug.
  
  
  OBJECTIVE
  To evaluate the effect of intraarticular injections of polymerized collagen after arthroscopic lavage on inflammation and clinical improvement in patients with knee osteoarthritis (OA).
  
  
  METHODS
  Patients (n = 19) were treated with 6 intraarticular injections of 2 mL of polymerized collagen (n = 10) or 2 mL of placebo (n = 9) during 3 months. Followup was 3 months. The primary endpoints included Lequesne index, pain on a visual analogue scale (VAS), WOMAC, analgesic usage, the number of Tregs and proinflammatory/anti-inflammatory cytokine-expressing peripheral cells. Secondary outcomes were Likert score and drug evaluation. Clinical and immunological improvement was determined if the decrease in pain exceeds 20 mm on a VAS, 20% of clinical outcomes, and inflammatory parameters from baseline. Urinary levels of C-terminal crosslinking telopeptide of collagen type II (CTXII) and erythrocyte sedimentation rate (ESR) were determined.
  
  
  RESULTS
  Polymerized collagen was safe and well tolerated. Patients had a statistically significant improvement (P < 0.05) from baseline versus polymerized collagen and versus placebo at 6 months on Lequesne index, VAS, ESR, Tregs IL-1β, and IL-10 peripheral-expressing cells. Urinary levels of CTXII were decreased 44% in polymerized collagen versus placebo. No differences were found on incidence of adverse events between groups.
  
  
  CONCLUSIONS
  Polymerized collagen is safe and effective on downregulation of inflammation in patients with knee OA.
authors.affiliation: Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Vasco de Quiroga No. 15, Col Sección XVI, 14000 Mexico City, DF, Mexico. jfuruzawa@gmail.com
authors.forename: Janette
authors.initials: J
authors.lastname: Furuzawa-Carballeda
authors.forename: Guadalupe
authors.initials: G
authors.lastname: Lima
authors.forename: Luis
authors.initials: L
authors.lastname: Llorente
authors.forename: Carlos
authors.initials: C
authors.lastname: Nuñez-Álvarez
authors.forename: Blanca H
authors.initials: BH
authors.lastname: Ruiz-Ordaz
authors.forename: Santiago
authors.initials: S
authors.lastname: Echevarría-Zuno
authors.forename: Virgilio
authors.initials: V
authors.lastname: Hernández-Cuevas
mesh_terms: D000328:Adult; D001182:Arthroscopy; D024042:Collagen Type I / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D005434:Flow Cytometry; D006801:Humans; D007249:Inflammation / Q000188:drug therapy*; D007963:Leukocytes, Mononuclear / Q000166:cytology; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy* / Q000601:surgery; D010919:Placebos; D007507:Therapeutic Irrigation; D016896:Treatment Outcome
chemical_list: D024042:Collagen Type I; D010919:Placebos