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

Objectives. Polymerized-type I collagen (polymerized collagen) is a downmodulator of inflammation and cartilage regenerator biodrug. Aim. To evaluate the effect of intraarticular injections of polymerized collagen after arthroscopic lavage on inflammation and clinical improvement in patients with kn...

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Main Authors: Janette Furuzawa-Carballeda, Guadalupe Lima, Luis Llorente, Carlos Nuñez-Álvarez, Blanca H. Ruiz-Ordaz, Santiago Echevarría-Zuno, Virgilio Hernández-Cuevas
Format: Article
Language:English
Published: Wiley 2012-01-01
Series:The Scientific World Journal
Online Access:http://dx.doi.org/10.1100/2012/342854
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author Janette Furuzawa-Carballeda
Guadalupe Lima
Luis Llorente
Carlos Nuñez-Álvarez
Blanca H. Ruiz-Ordaz
Santiago Echevarría-Zuno
Virgilio Hernández-Cuevas
author_facet Janette Furuzawa-Carballeda
Guadalupe Lima
Luis Llorente
Carlos Nuñez-Álvarez
Blanca H. Ruiz-Ordaz
Santiago Echevarría-Zuno
Virgilio Hernández-Cuevas
author_sort Janette Furuzawa-Carballeda
collection DOAJ
description Objectives. Polymerized-type I collagen (polymerized collagen) is a downmodulator of inflammation and cartilage regenerator biodrug. Aim. 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. Conclusion. Polymerized collagen is safe and effective on downregulation of inflammation in patients with knee OA.
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spelling doaj-art-b017fa3cdd494cff82531eff4a5551032025-02-03T05:59:14ZengWileyThe Scientific World Journal1537-744X2012-01-01201210.1100/2012/342854342854Polymerized-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 TrialJanette Furuzawa-Carballeda0Guadalupe Lima1Luis Llorente2Carlos Nuñez-Álvarez3Blanca H. Ruiz-Ordaz4Santiago Echevarría-Zuno5Virgilio Hernández-Cuevas6Department 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, MexicoDepartment 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, MexicoDepartment 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, MexicoDepartment 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, MexicoDepartment of Molecular Biology and Biotechnology, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Apartado Postal 04510, México City, DF, MexicoUnidad Médica de Alta Especialidad, Hospital de Traumatología y Ortopedia, IMSS, Boulevard Manuel Ávila Camacho s/n, Ex-ejido de Oro, 53120 Naucalpan, MEX, MexicoUnidad Médica de Alta Especialidad, Hospital de Traumatología y Ortopedia, IMSS, Boulevard Manuel Ávila Camacho s/n, Ex-ejido de Oro, 53120 Naucalpan, MEX, MexicoObjectives. Polymerized-type I collagen (polymerized collagen) is a downmodulator of inflammation and cartilage regenerator biodrug. Aim. 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. Conclusion. Polymerized collagen is safe and effective on downregulation of inflammation in patients with knee OA.http://dx.doi.org/10.1100/2012/342854
spellingShingle Janette Furuzawa-Carballeda
Guadalupe Lima
Luis Llorente
Carlos Nuñez-Álvarez
Blanca H. Ruiz-Ordaz
Santiago Echevarría-Zuno
Virgilio Hernández-Cuevas
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
The Scientific World Journal
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
url http://dx.doi.org/10.1100/2012/342854
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