First-in-Man Clinical Pilot Study Showing the Safety and Efficacy of Intramuscular Injection of Basic Fibroblast Growth Factor With Atelocollagen Solution for Critical Limb Ischemia
Background: Therapeutic angiogenesis with basic fibroblast growth factor (bFGF) with atelocollagen was confirmed in a study using a limb ischemia mouse model. Because the number of elderly patients with critical limb ischemia (CLI) is increasing, particularly that caused by arteriosclerosis oblitera...
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| Veröffentlicht in: | Circulation Journal 2018/12/25, Vol.83(1), pp.217-223 |
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| creator | Ono, Kazunori Yanishi, Kenji Ariyoshi, Makoto Kaimoto, Satoshi Uchihashi, Motoki Shoji, Keisuke Matoba, Satoaki |
| description | Background: Therapeutic angiogenesis with basic fibroblast growth factor (bFGF) with atelocollagen was confirmed in a study using a limb ischemia mouse model. Because the number of elderly patients with critical limb ischemia (CLI) is increasing, particularly that caused by arteriosclerosis obliterans (ASO), the development of less invasive angiogenesis therapies desired. Methods and Results: This first-in-man clinical study was designed to assess the safety and efficacy of i.m. injection of bFGF with atelocollagen. Human recombinant bFGF (200 μg), combined with 4.8 mL 3% atelocollagen solution, was prepared and injected into the gastrocnemius muscle of the ischemic leg. The primary endpoint was safety, evaluated on all adverse events over 48 weeks after this treatment. The secondary endpoint was efficacy, evaluated by improvement of ischemic symptoms. No serious procedure-related adverse events were observed during the follow-up period. Visual analogue scale (VAS) score was significantly improved at 4, 24 and 48 weeks compared with baseline (P |
| doi_str_mv | 10.1253/circj.CJ-18-0815 |
| format | Article |
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Because the number of elderly patients with critical limb ischemia (CLI) is increasing, particularly that caused by arteriosclerosis obliterans (ASO), the development of less invasive angiogenesis therapies desired. Methods and Results: This first-in-man clinical study was designed to assess the safety and efficacy of i.m. injection of bFGF with atelocollagen. Human recombinant bFGF (200 μg), combined with 4.8 mL 3% atelocollagen solution, was prepared and injected into the gastrocnemius muscle of the ischemic leg. The primary endpoint was safety, evaluated on all adverse events over 48 weeks after this treatment. The secondary endpoint was efficacy, evaluated by improvement of ischemic symptoms. No serious procedure-related adverse events were observed during the follow-up period. Visual analogue scale (VAS) score was significantly improved at 4, 24 and 48 weeks compared with baseline (P<0.05), and 7 patients became pain free during the follow-up period. Fontaine classification was improved in 4 of 10 patients at 48 weeks. Cyanotic lesions disappeared in 2 patients at 4 weeks. Conclusions: I.m. injection of bFGF with atelocollagen is safe and feasible in patients with CLI. Randomized controlled trials are therefore needed to confirm these results.</description><identifier>ISSN: 1346-9843</identifier><identifier>ISSN: 1347-4820</identifier><identifier>EISSN: 1347-4820</identifier><identifier>DOI: 10.1253/circj.CJ-18-0815</identifier><identifier>PMID: 30416190</identifier><language>eng</language><publisher>Japan: The Japanese Circulation Society</publisher><subject>Aged ; Aged, 80 and over ; Basic fibroblast growth factor ; Collagen - administration & dosage ; Critical limb ischemia ; Extremities - blood supply ; Extremities - pathology ; Extremities - physiopathology ; Female ; Fibroblast Growth Factor 2 - administration & dosage ; Follow-Up Studies ; Humans ; Injections, Intramuscular ; Ischemia - drug therapy ; Ischemia - pathology ; Ischemia - physiopathology ; Male ; Middle Aged ; Peripheral artery disease ; Pilot Projects ; Therapeutic angiogenesis</subject><ispartof>Circulation Journal, 2018/12/25, Vol.83(1), pp.217-223</ispartof><rights>2019 THE JAPANESE CIRCULATION SOCIETY</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c494t-3df197b6e777080dfccc516903abcda7ba22e09b5bf7aae53f0a841cf9ef87593</citedby><cites>FETCH-LOGICAL-c494t-3df197b6e777080dfccc516903abcda7ba22e09b5bf7aae53f0a841cf9ef87593</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,1883,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30416190$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ono, Kazunori</creatorcontrib><creatorcontrib>Yanishi, Kenji</creatorcontrib><creatorcontrib>Ariyoshi, Makoto</creatorcontrib><creatorcontrib>Kaimoto, Satoshi</creatorcontrib><creatorcontrib>Uchihashi, Motoki</creatorcontrib><creatorcontrib>Shoji, Keisuke</creatorcontrib><creatorcontrib>Matoba, Satoaki</creatorcontrib><title>First-in-Man Clinical Pilot Study Showing the Safety and Efficacy of Intramuscular Injection of Basic Fibroblast Growth Factor With Atelocollagen Solution for Critical Limb Ischemia</title><title>Circulation Journal</title><addtitle>Circ J</addtitle><description>Background: Therapeutic angiogenesis with basic fibroblast growth factor (bFGF) with atelocollagen was confirmed in a study using a limb ischemia mouse model. Because the number of elderly patients with critical limb ischemia (CLI) is increasing, particularly that caused by arteriosclerosis obliterans (ASO), the development of less invasive angiogenesis therapies desired. Methods and Results: This first-in-man clinical study was designed to assess the safety and efficacy of i.m. injection of bFGF with atelocollagen. Human recombinant bFGF (200 μg), combined with 4.8 mL 3% atelocollagen solution, was prepared and injected into the gastrocnemius muscle of the ischemic leg. The primary endpoint was safety, evaluated on all adverse events over 48 weeks after this treatment. The secondary endpoint was efficacy, evaluated by improvement of ischemic symptoms. No serious procedure-related adverse events were observed during the follow-up period. Visual analogue scale (VAS) score was significantly improved at 4, 24 and 48 weeks compared with baseline (P<0.05), and 7 patients became pain free during the follow-up period. Fontaine classification was improved in 4 of 10 patients at 48 weeks. Cyanotic lesions disappeared in 2 patients at 4 weeks. Conclusions: I.m. injection of bFGF with atelocollagen is safe and feasible in patients with CLI. Randomized controlled trials are therefore needed to confirm these results.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Basic fibroblast growth factor</subject><subject>Collagen - administration & dosage</subject><subject>Critical limb ischemia</subject><subject>Extremities - blood supply</subject><subject>Extremities - pathology</subject><subject>Extremities - physiopathology</subject><subject>Female</subject><subject>Fibroblast Growth Factor 2 - administration & dosage</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Injections, Intramuscular</subject><subject>Ischemia - drug therapy</subject><subject>Ischemia - pathology</subject><subject>Ischemia - physiopathology</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Peripheral artery disease</subject><subject>Pilot Projects</subject><subject>Therapeutic angiogenesis</subject><issn>1346-9843</issn><issn>1347-4820</issn><issn>1347-4820</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkU1v3CAQhq2qVfPR3nuqOPbiBIy9hmNqxelGW7XStuoRjTFkWWFIASvaH5b_V_ajyQVmNM_7ajRvUXwi-IpUDb2WJsjtVXdfElZiRpo3xTmhdVvWrMJvD_Wi5KymZ8VFjFuMK44b_r44o7gmC8LxefHcmxBTaVz5HRzqrHFGgkU_jfUJrdM87tB645-Me0Bpo9AatEo7BG5Et1pnVO6Q12jpUoBpjnK2EHK3VTIZ7_ajrxCNRL0Zgh8sxITugn9KG9SDTD6gPybXN0lZL7218KAcWns7H9Q6z7tg0mGjlZkGtIxyoyYDH4p3GmxUH0__ZfG7v_3VfStXP-6W3c2qlDWvU0lHTXg7LFTbtpjhUUspG7LgmMIgR2gHqCqF-dAMugVQDdUYWE2k5kqztuH0svhy9H0M_u-sYhKTiVLlRZ3ycxQVoVXFCavajOIjKoOPMSgtHoOZIOwEwWIfljiEJbp7QZjYh5Uln0_u8zCp8UXwP50M9EdgG1M-zQsAId_EqpMjo4Lsn1fnV2ADQShH_wFRoK5F</recordid><startdate>20181225</startdate><enddate>20181225</enddate><creator>Ono, Kazunori</creator><creator>Yanishi, Kenji</creator><creator>Ariyoshi, Makoto</creator><creator>Kaimoto, Satoshi</creator><creator>Uchihashi, Motoki</creator><creator>Shoji, Keisuke</creator><creator>Matoba, Satoaki</creator><general>The Japanese Circulation Society</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20181225</creationdate><title>First-in-Man Clinical Pilot Study Showing the Safety and Efficacy of Intramuscular Injection of Basic Fibroblast Growth Factor With Atelocollagen Solution for Critical Limb Ischemia</title><author>Ono, Kazunori ; Yanishi, Kenji ; Ariyoshi, Makoto ; Kaimoto, Satoshi ; Uchihashi, Motoki ; Shoji, Keisuke ; Matoba, Satoaki</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c494t-3df197b6e777080dfccc516903abcda7ba22e09b5bf7aae53f0a841cf9ef87593</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Basic fibroblast growth factor</topic><topic>Collagen - administration & dosage</topic><topic>Critical limb ischemia</topic><topic>Extremities - blood supply</topic><topic>Extremities - pathology</topic><topic>Extremities - physiopathology</topic><topic>Female</topic><topic>Fibroblast Growth Factor 2 - administration & dosage</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Injections, Intramuscular</topic><topic>Ischemia - drug therapy</topic><topic>Ischemia - pathology</topic><topic>Ischemia - physiopathology</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Peripheral artery disease</topic><topic>Pilot Projects</topic><topic>Therapeutic angiogenesis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ono, Kazunori</creatorcontrib><creatorcontrib>Yanishi, Kenji</creatorcontrib><creatorcontrib>Ariyoshi, Makoto</creatorcontrib><creatorcontrib>Kaimoto, Satoshi</creatorcontrib><creatorcontrib>Uchihashi, Motoki</creatorcontrib><creatorcontrib>Shoji, Keisuke</creatorcontrib><creatorcontrib>Matoba, Satoaki</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Circulation Journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ono, Kazunori</au><au>Yanishi, Kenji</au><au>Ariyoshi, Makoto</au><au>Kaimoto, Satoshi</au><au>Uchihashi, Motoki</au><au>Shoji, Keisuke</au><au>Matoba, Satoaki</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>First-in-Man Clinical Pilot Study Showing the Safety and Efficacy of Intramuscular Injection of Basic Fibroblast Growth Factor With Atelocollagen Solution for Critical Limb Ischemia</atitle><jtitle>Circulation Journal</jtitle><addtitle>Circ J</addtitle><date>2018-12-25</date><risdate>2018</risdate><volume>83</volume><issue>1</issue><spage>217</spage><epage>223</epage><pages>217-223</pages><issn>1346-9843</issn><issn>1347-4820</issn><eissn>1347-4820</eissn><abstract>Background: Therapeutic angiogenesis with basic fibroblast growth factor (bFGF) with atelocollagen was confirmed in a study using a limb ischemia mouse model. Because the number of elderly patients with critical limb ischemia (CLI) is increasing, particularly that caused by arteriosclerosis obliterans (ASO), the development of less invasive angiogenesis therapies desired. Methods and Results: This first-in-man clinical study was designed to assess the safety and efficacy of i.m. injection of bFGF with atelocollagen. Human recombinant bFGF (200 μg), combined with 4.8 mL 3% atelocollagen solution, was prepared and injected into the gastrocnemius muscle of the ischemic leg. The primary endpoint was safety, evaluated on all adverse events over 48 weeks after this treatment. The secondary endpoint was efficacy, evaluated by improvement of ischemic symptoms. No serious procedure-related adverse events were observed during the follow-up period. Visual analogue scale (VAS) score was significantly improved at 4, 24 and 48 weeks compared with baseline (P<0.05), and 7 patients became pain free during the follow-up period. Fontaine classification was improved in 4 of 10 patients at 48 weeks. Cyanotic lesions disappeared in 2 patients at 4 weeks. Conclusions: I.m. injection of bFGF with atelocollagen is safe and feasible in patients with CLI. Randomized controlled trials are therefore needed to confirm these results.</abstract><cop>Japan</cop><pub>The Japanese Circulation Society</pub><pmid>30416190</pmid><doi>10.1253/circj.CJ-18-0815</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Aged Aged, 80 and over Basic fibroblast growth factor Collagen - administration & dosage Critical limb ischemia Extremities - blood supply Extremities - pathology Extremities - physiopathology Female Fibroblast Growth Factor 2 - administration & dosage Follow-Up Studies Humans Injections, Intramuscular Ischemia - drug therapy Ischemia - pathology Ischemia - physiopathology Male Middle Aged Peripheral artery disease Pilot Projects Therapeutic angiogenesis |
| title | First-in-Man Clinical Pilot Study Showing the Safety and Efficacy of Intramuscular Injection of Basic Fibroblast Growth Factor With Atelocollagen Solution for Critical Limb Ischemia |
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