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Human adipose-derived Mesenchymal stem cells, low-intensity pulsed ultrasound, or their combination for the treatment of knee osteoarthritis: study protocol for a first-in-man randomized controlled trial
Human adipose-derived Mesenchymal stem cells (HADMSCs) have proven their efficacy in treating osteoarthritis (OA), in earlier preclinical and clinical studies. As the tissue repairers are under the control of mechanical and biochemical signals, improving regeneration outcomes using such signals has...
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Published in: | BMC musculoskeletal disorders 2020-01, Vol.21 (1), p.33-33, Article 33 |
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description | Human adipose-derived Mesenchymal stem cells (HADMSCs) have proven their efficacy in treating osteoarthritis (OA), in earlier preclinical and clinical studies. As the tissue repairers are under the control of mechanical and biochemical signals, improving regeneration outcomes using such signals has of late been the focus of attention. Among mechanical stimuli, low-intensity pulsed ultrasound (LIPUS) has recently shown promise both in vitro and in vivo. This study will investigate the potential of LIPUS in enhancing the regeneration process of an osteoarthritic knee joint.
This study involves a prospective, randomized, placebo-controlled, and single-blind trial based on the SPIRIT guidelines, and aims to recruit 96 patients initially diagnosed with knee osteoarthritis, following American College of Rheumatology criteria. Patients will be randomized in a 1:1:1 ratio to receive Intraarticular HADMSCs injection with LIPUS, Intraarticular HADMSCs injection with shame LIPUS, or Normal saline with LIPUS. The primary outcome is Western Ontario and McMaster Universities Index of OA (WOMAC) score, while the secondary outcomes will be other knee structural changes, and lower limb muscle strength such as the knee cartilage thickness measured by MRI. Blinded assessments will be performed at baseline (1 month prior to treatment), 1 month, 3 months, and 6 months following the interventions.
This trial will be the first clinical study to comprehensively investigate the safety and efficacy of LIPUS on stem cell therapy in OA patients. The results may provide evidence of the effectiveness of LIPUS in improving stem cell therapy and deliver valuable information for the design of subsequent trials.
This study had been prospectively registered with the Chinese Clinical Trials Registry. registration number: ChiCTR1900025907 at September 14, 2019. |
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This study involves a prospective, randomized, placebo-controlled, and single-blind trial based on the SPIRIT guidelines, and aims to recruit 96 patients initially diagnosed with knee osteoarthritis, following American College of Rheumatology criteria. Patients will be randomized in a 1:1:1 ratio to receive Intraarticular HADMSCs injection with LIPUS, Intraarticular HADMSCs injection with shame LIPUS, or Normal saline with LIPUS. The primary outcome is Western Ontario and McMaster Universities Index of OA (WOMAC) score, while the secondary outcomes will be other knee structural changes, and lower limb muscle strength such as the knee cartilage thickness measured by MRI. Blinded assessments will be performed at baseline (1 month prior to treatment), 1 month, 3 months, and 6 months following the interventions.
This trial will be the first clinical study to comprehensively investigate the safety and efficacy of LIPUS on stem cell therapy in OA patients. The results may provide evidence of the effectiveness of LIPUS in improving stem cell therapy and deliver valuable information for the design of subsequent trials.
This study had been prospectively registered with the Chinese Clinical Trials Registry. registration number: ChiCTR1900025907 at September 14, 2019.</description><identifier>ISSN: 1471-2474</identifier><identifier>EISSN: 1471-2474</identifier><identifier>DOI: 10.1186/s12891-020-3056-4</identifier><identifier>PMID: 31941483</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Abdomen ; Anopheles ; Arthritis ; Attention ; Care and treatment ; Cartilage diseases ; Cell growth ; Cell therapy ; Clinical trials ; Diagnostic imaging ; Health aspects ; Injection ; Knee ; Low-intensity ultrasound ; Magnetic resonance imaging ; Mechanical stimuli ; Medical research ; Mesenchymal stem cells ; Methods ; Muscle strength ; Musculoskeletal ; Osteoarthritis ; Pain ; Patients ; Stem cell transplantation ; Stem cells ; Study Protocol ; Ultrasonic imaging ; Ultrasound</subject><ispartof>BMC musculoskeletal disorders, 2020-01, Vol.21 (1), p.33-33, Article 33</ispartof><rights>COPYRIGHT 2020 BioMed Central Ltd.</rights><rights>2020. This work is licensed under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>The Author(s). 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c560t-80b927be9034eb4c4c70661d761b5158d0d63d8ee8a97d9d79a70ea06ebf59ae3</citedby><cites>FETCH-LOGICAL-c560t-80b927be9034eb4c4c70661d761b5158d0d63d8ee8a97d9d79a70ea06ebf59ae3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6964002/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/2340732584?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,25753,27924,27925,37012,37013,44590,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31941483$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nasb, Mohammad</creatorcontrib><creatorcontrib>Liangjiang, Huang</creatorcontrib><creatorcontrib>Gong, Chenzi</creatorcontrib><creatorcontrib>Hong, Chen</creatorcontrib><title>Human adipose-derived Mesenchymal stem cells, low-intensity pulsed ultrasound, or their combination for the treatment of knee osteoarthritis: study protocol for a first-in-man randomized controlled trial</title><title>BMC musculoskeletal disorders</title><addtitle>BMC Musculoskelet Disord</addtitle><description>Human adipose-derived Mesenchymal stem cells (HADMSCs) have proven their efficacy in treating osteoarthritis (OA), in earlier preclinical and clinical studies. As the tissue repairers are under the control of mechanical and biochemical signals, improving regeneration outcomes using such signals has of late been the focus of attention. Among mechanical stimuli, low-intensity pulsed ultrasound (LIPUS) has recently shown promise both in vitro and in vivo. This study will investigate the potential of LIPUS in enhancing the regeneration process of an osteoarthritic knee joint.
This study involves a prospective, randomized, placebo-controlled, and single-blind trial based on the SPIRIT guidelines, and aims to recruit 96 patients initially diagnosed with knee osteoarthritis, following American College of Rheumatology criteria. Patients will be randomized in a 1:1:1 ratio to receive Intraarticular HADMSCs injection with LIPUS, Intraarticular HADMSCs injection with shame LIPUS, or Normal saline with LIPUS. The primary outcome is Western Ontario and McMaster Universities Index of OA (WOMAC) score, while the secondary outcomes will be other knee structural changes, and lower limb muscle strength such as the knee cartilage thickness measured by MRI. Blinded assessments will be performed at baseline (1 month prior to treatment), 1 month, 3 months, and 6 months following the interventions.
This trial will be the first clinical study to comprehensively investigate the safety and efficacy of LIPUS on stem cell therapy in OA patients. The results may provide evidence of the effectiveness of LIPUS in improving stem cell therapy and deliver valuable information for the design of subsequent trials.
This study had been prospectively registered with the Chinese Clinical Trials Registry. registration number: ChiCTR1900025907 at September 14, 2019.</description><subject>Abdomen</subject><subject>Anopheles</subject><subject>Arthritis</subject><subject>Attention</subject><subject>Care and treatment</subject><subject>Cartilage diseases</subject><subject>Cell growth</subject><subject>Cell therapy</subject><subject>Clinical trials</subject><subject>Diagnostic imaging</subject><subject>Health aspects</subject><subject>Injection</subject><subject>Knee</subject><subject>Low-intensity ultrasound</subject><subject>Magnetic resonance imaging</subject><subject>Mechanical stimuli</subject><subject>Medical research</subject><subject>Mesenchymal stem cells</subject><subject>Methods</subject><subject>Muscle strength</subject><subject>Musculoskeletal</subject><subject>Osteoarthritis</subject><subject>Pain</subject><subject>Patients</subject><subject>Stem cell transplantation</subject><subject>Stem cells</subject><subject>Study Protocol</subject><subject>Ultrasonic imaging</subject><subject>Ultrasound</subject><issn>1471-2474</issn><issn>1471-2474</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>PIMPY</sourceid><sourceid>DOA</sourceid><recordid>eNptUk1vFSEUnRiNrdUf4MaQuHHRqTAwMLho0jRqm9S40TVh4M57PGfgCUzN8y_6p2T6am2NYQG5nHvO_ThV9ZLgE0I6_jaRppOkxg2uKW55zR5Vh4QJUjdMsMf33gfVs5Q2GBPRUfm0OqBEMsI6elj9upgn7ZG2bhsS1BaiuwaLPkECb9a7SY8oZZiQgXFMx2gMP2rnM_jk8g5t5zEV8DzmqFOYvT1GIaK8BheRCVPvvM4ueDTsoyhH0HkCn1EY0DcPgEIhDzrmdXTZpXdFa7aFN4YcTBhvEjUaXEy5yNZLpVF7Gyb3s-ia4HMM41ieOTo9Pq-eDLpU9OL2Pqq-fnj_5fyivvr88fL87Ko2Lce57nAvG9GDxJRBzwwzAnNOrOCkb0nbWWw5tR1Ap6Ww0gqpBQaNOfRDKzXQo-pyz2uD3qhtdJOOOxW0UzeBEFeqtOTMCMoOfRlzwzkrOtBbrUF2MGAQlDNgC9fpnms79xNYU4YT9fiA9OGPd2u1CteKS84wbgrBm1uCGL7PkLKaXFq2pT2EOamGUik6SSku0Nf_QDdhjr6MqqAYFrRpO_YXtdKlAeeHUHTNQqrOOOkEkVTKgjr5D6ocC5Mri4HBlfiDBLJPMDGkFGG465FgtbhZ7d2sipvV4ma1lPLq_nDuMv7Yl_4GVf_1hw</recordid><startdate>20200115</startdate><enddate>20200115</enddate><creator>Nasb, Mohammad</creator><creator>Liangjiang, Huang</creator><creator>Gong, Chenzi</creator><creator>Hong, Chen</creator><general>BioMed Central Ltd</general><general>BioMed Central</general><general>BMC</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QP</scope><scope>7RV</scope><scope>7TK</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20200115</creationdate><title>Human adipose-derived Mesenchymal stem cells, low-intensity pulsed ultrasound, or their combination for the treatment of knee osteoarthritis: study protocol for a first-in-man randomized controlled trial</title><author>Nasb, Mohammad ; Liangjiang, Huang ; Gong, Chenzi ; Hong, Chen</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c560t-80b927be9034eb4c4c70661d761b5158d0d63d8ee8a97d9d79a70ea06ebf59ae3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Abdomen</topic><topic>Anopheles</topic><topic>Arthritis</topic><topic>Attention</topic><topic>Care and treatment</topic><topic>Cartilage diseases</topic><topic>Cell growth</topic><topic>Cell therapy</topic><topic>Clinical trials</topic><topic>Diagnostic imaging</topic><topic>Health aspects</topic><topic>Injection</topic><topic>Knee</topic><topic>Low-intensity ultrasound</topic><topic>Magnetic resonance imaging</topic><topic>Mechanical stimuli</topic><topic>Medical research</topic><topic>Mesenchymal stem cells</topic><topic>Methods</topic><topic>Muscle strength</topic><topic>Musculoskeletal</topic><topic>Osteoarthritis</topic><topic>Pain</topic><topic>Patients</topic><topic>Stem cell transplantation</topic><topic>Stem cells</topic><topic>Study Protocol</topic><topic>Ultrasonic imaging</topic><topic>Ultrasound</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nasb, Mohammad</creatorcontrib><creatorcontrib>Liangjiang, Huang</creatorcontrib><creatorcontrib>Gong, Chenzi</creatorcontrib><creatorcontrib>Hong, Chen</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Neurosciences Abstracts</collection><collection>Physical Education Index</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>BMC musculoskeletal disorders</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nasb, Mohammad</au><au>Liangjiang, Huang</au><au>Gong, Chenzi</au><au>Hong, Chen</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Human adipose-derived Mesenchymal stem cells, low-intensity pulsed ultrasound, or their combination for the treatment of knee osteoarthritis: study protocol for a first-in-man randomized controlled trial</atitle><jtitle>BMC musculoskeletal disorders</jtitle><addtitle>BMC Musculoskelet Disord</addtitle><date>2020-01-15</date><risdate>2020</risdate><volume>21</volume><issue>1</issue><spage>33</spage><epage>33</epage><pages>33-33</pages><artnum>33</artnum><issn>1471-2474</issn><eissn>1471-2474</eissn><abstract>Human adipose-derived Mesenchymal stem cells (HADMSCs) have proven their efficacy in treating osteoarthritis (OA), in earlier preclinical and clinical studies. As the tissue repairers are under the control of mechanical and biochemical signals, improving regeneration outcomes using such signals has of late been the focus of attention. Among mechanical stimuli, low-intensity pulsed ultrasound (LIPUS) has recently shown promise both in vitro and in vivo. This study will investigate the potential of LIPUS in enhancing the regeneration process of an osteoarthritic knee joint.
This study involves a prospective, randomized, placebo-controlled, and single-blind trial based on the SPIRIT guidelines, and aims to recruit 96 patients initially diagnosed with knee osteoarthritis, following American College of Rheumatology criteria. Patients will be randomized in a 1:1:1 ratio to receive Intraarticular HADMSCs injection with LIPUS, Intraarticular HADMSCs injection with shame LIPUS, or Normal saline with LIPUS. The primary outcome is Western Ontario and McMaster Universities Index of OA (WOMAC) score, while the secondary outcomes will be other knee structural changes, and lower limb muscle strength such as the knee cartilage thickness measured by MRI. Blinded assessments will be performed at baseline (1 month prior to treatment), 1 month, 3 months, and 6 months following the interventions.
This trial will be the first clinical study to comprehensively investigate the safety and efficacy of LIPUS on stem cell therapy in OA patients. The results may provide evidence of the effectiveness of LIPUS in improving stem cell therapy and deliver valuable information for the design of subsequent trials.
This study had been prospectively registered with the Chinese Clinical Trials Registry. registration number: ChiCTR1900025907 at September 14, 2019.</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>31941483</pmid><doi>10.1186/s12891-020-3056-4</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Abdomen Anopheles Arthritis Attention Care and treatment Cartilage diseases Cell growth Cell therapy Clinical trials Diagnostic imaging Health aspects Injection Knee Low-intensity ultrasound Magnetic resonance imaging Mechanical stimuli Medical research Mesenchymal stem cells Methods Muscle strength Musculoskeletal Osteoarthritis Pain Patients Stem cell transplantation Stem cells Study Protocol Ultrasonic imaging Ultrasound |
title | Human adipose-derived Mesenchymal stem cells, low-intensity pulsed ultrasound, or their combination for the treatment of knee osteoarthritis: study protocol for a first-in-man randomized controlled trial |
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