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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...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2020
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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 |
_version_ | 1783564201914007552 |
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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. |
format | Online Article Text |
id | pubmed-7387819 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
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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