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A novel approach for knee osteoarthritis using high molecular weight hyaluronic acid conjugated to plasma fibrinogen – interim findings of a double-blind clinical study

OBJECTIVE: Osteoarthritis (OA) is a widespread degenerative joint disease leading to progressive loss of function and pain. Available treatments do not provide long-term relief or improvement. This study aimed to assess the safety and efficacy of a novel intra articular supplement, made of high mole...

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Autores principales: Kandel, Leonid, Agar, Gabriel, Elkayam, Ori, Sharipov, Aybek, Slevin, Omer, Rivkin, Gurion, Dahan, Moshe, Aloush, Valerie, Pyeser, Amos B., Brin, Yaron, Beer, Yiftah, Yayon, Avner
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7387819/
https://www.ncbi.nlm.nih.gov/pubmed/32743094
http://dx.doi.org/10.1016/j.heliyon.2020.e04475
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author Kandel, Leonid
Agar, Gabriel
Elkayam, Ori
Sharipov, Aybek
Slevin, Omer
Rivkin, Gurion
Dahan, Moshe
Aloush, Valerie
Pyeser, Amos B.
Brin, Yaron
Beer, Yiftah
Yayon, Avner
author_facet Kandel, Leonid
Agar, Gabriel
Elkayam, Ori
Sharipov, Aybek
Slevin, Omer
Rivkin, Gurion
Dahan, Moshe
Aloush, Valerie
Pyeser, Amos B.
Brin, Yaron
Beer, Yiftah
Yayon, Avner
author_sort Kandel, Leonid
collection PubMed
description OBJECTIVE: Osteoarthritis (OA) is a widespread degenerative joint disease leading to progressive loss of function and pain. Available treatments do not provide long-term relief or improvement. This study aimed to assess the safety and efficacy of a novel intra articular supplement, made of high molecular-weight hyaluronic acid (HA) uniquely conjugated to either purified (RegenoGel) or autologous plasma-derived fibrinogen (RegenoGel-OSP), as a long-term treatment for knee OA. METHODS: Sixty-seven consecutive participants (mean age 67.26 ± 7 years) with symptomatic OA were randomly assigned to receive intraarticular injections of either RegenoGel, RegenoGel-OSP or saline solution (placebo). The active treatment groups received a second, repeat injection of the corresponding treatment at the 3-month evaluation, at which time, the placebo group was divided into two subgroups, one receiving RegenoGel and the other receiving RegenoGel-OSP. The OA symptoms were assessed by VAS, WOMAC, and IKDC questionnaires at baseline and at 1, 3, 4, and 6 months following the first injection. OA-related quality of life was evaluated by the SF-12 survey. RESULTS: Our preliminary data suggests that both fibrin-HA formulations have positive effects on OA symptoms for all assessed parameters with the most prominent trend for reduction in OA-associated pain. Pooled data analysis of RegenoGel and RegenoGel-OSP shows significantly improved VAS scores compared to placebo at three months after the first injection, and sustained for another three months after the second injection. Both RegenoGel, RegenoGel-OSP had an excellent safety profile. CONCLUSIONS: Interim analysis results indicate that RegenoGel and RegenoGel-OSP are safe and are potentially effective for at least six months in alleviating pain and symptoms of knee OA.
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spelling pubmed-73878192020-07-31 A novel approach for knee osteoarthritis using high molecular weight hyaluronic acid conjugated to plasma fibrinogen – interim findings of a double-blind clinical study Kandel, Leonid Agar, Gabriel Elkayam, Ori Sharipov, Aybek Slevin, Omer Rivkin, Gurion Dahan, Moshe Aloush, Valerie Pyeser, Amos B. Brin, Yaron Beer, Yiftah Yayon, Avner Heliyon Article OBJECTIVE: Osteoarthritis (OA) is a widespread degenerative joint disease leading to progressive loss of function and pain. Available treatments do not provide long-term relief or improvement. This study aimed to assess the safety and efficacy of a novel intra articular supplement, made of high molecular-weight hyaluronic acid (HA) uniquely conjugated to either purified (RegenoGel) or autologous plasma-derived fibrinogen (RegenoGel-OSP), as a long-term treatment for knee OA. METHODS: Sixty-seven consecutive participants (mean age 67.26 ± 7 years) with symptomatic OA were randomly assigned to receive intraarticular injections of either RegenoGel, RegenoGel-OSP or saline solution (placebo). The active treatment groups received a second, repeat injection of the corresponding treatment at the 3-month evaluation, at which time, the placebo group was divided into two subgroups, one receiving RegenoGel and the other receiving RegenoGel-OSP. The OA symptoms were assessed by VAS, WOMAC, and IKDC questionnaires at baseline and at 1, 3, 4, and 6 months following the first injection. OA-related quality of life was evaluated by the SF-12 survey. RESULTS: Our preliminary data suggests that both fibrin-HA formulations have positive effects on OA symptoms for all assessed parameters with the most prominent trend for reduction in OA-associated pain. Pooled data analysis of RegenoGel and RegenoGel-OSP shows significantly improved VAS scores compared to placebo at three months after the first injection, and sustained for another three months after the second injection. Both RegenoGel, RegenoGel-OSP had an excellent safety profile. CONCLUSIONS: Interim analysis results indicate that RegenoGel and RegenoGel-OSP are safe and are potentially effective for at least six months in alleviating pain and symptoms of knee OA. Elsevier 2020-07-23 /pmc/articles/PMC7387819/ /pubmed/32743094 http://dx.doi.org/10.1016/j.heliyon.2020.e04475 Text en © 2020 The Authors. Published by Elsevier Ltd. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Article
Kandel, Leonid
Agar, Gabriel
Elkayam, Ori
Sharipov, Aybek
Slevin, Omer
Rivkin, Gurion
Dahan, Moshe
Aloush, Valerie
Pyeser, Amos B.
Brin, Yaron
Beer, Yiftah
Yayon, Avner
A novel approach for knee osteoarthritis using high molecular weight hyaluronic acid conjugated to plasma fibrinogen – interim findings of a double-blind clinical study
title A novel approach for knee osteoarthritis using high molecular weight hyaluronic acid conjugated to plasma fibrinogen – interim findings of a double-blind clinical study
title_full A novel approach for knee osteoarthritis using high molecular weight hyaluronic acid conjugated to plasma fibrinogen – interim findings of a double-blind clinical study
title_fullStr A novel approach for knee osteoarthritis using high molecular weight hyaluronic acid conjugated to plasma fibrinogen – interim findings of a double-blind clinical study
title_full_unstemmed A novel approach for knee osteoarthritis using high molecular weight hyaluronic acid conjugated to plasma fibrinogen – interim findings of a double-blind clinical study
title_short A novel approach for knee osteoarthritis using high molecular weight hyaluronic acid conjugated to plasma fibrinogen – interim findings of a double-blind clinical study
title_sort novel approach for knee osteoarthritis using high molecular weight hyaluronic acid conjugated to plasma fibrinogen – interim findings of a double-blind clinical study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7387819/
https://www.ncbi.nlm.nih.gov/pubmed/32743094
http://dx.doi.org/10.1016/j.heliyon.2020.e04475
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