Intervariability and intravariability of bone morphogenetic proteins in commercially available demineralized bone matrix products
Enzyme-linked immunosorbent assay was used to detect bone morphogenetic proteins (BMPs) 2, 4, and 7 in 9 commercially available ("off the shelf") demineralized bone matrix (DBM) product formulations using 3 different manufacturer's production lots of each DBM formulation. To evaluate...
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| Veröffentlicht in: | Spine (Philadelphia, Pa. 1976) Pa. 1976), 2006-05, Vol.31 (12), p.1299-1308 |
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| creator | BAE, Hyun W LI ZHAO KANIM, Linda E. A WONG, Pamela DELAMARTER, Rick B DAWSON, Edgar G EINHORN, Thomas A |
| description | Enzyme-linked immunosorbent assay was used to detect bone morphogenetic proteins (BMPs) 2, 4, and 7 in 9 commercially available ("off the shelf") demineralized bone matrix (DBM) product formulations using 3 different manufacturer's production lots of each DBM formulation.
To evaluate and compare the quantity of BMPs among several different DBM formulations (inter-product variability), as well as examine the variability of these proteins in different production lots within the same DBM formulation (intra-product variability).
DBMs are commonly used to augment available bone graft in spinal fusion procedures. Surgeons are presented with an ever-increasing variety of commercially available human DBMs from which to choose. Yet, there is limited information on a specific DBM product's osteoinductive efficacy, potency, and constancy.
There were protein extracts from each DBM sample separately dialyzed 4 times against distilled water at 4 degrees C for 48 hours. The amount of BMP-2, BMP-4, and BMP-7 was determined using enzyme-linked immunosorbent assay. RESULTS.: The concentrations of detected BMP-2 and BMP-7 were low for all DBM formulations, only nanograms of BMP were extracted from each gram of DBM (20.2-120.6 ng BMP-2/g DBM product; 54.2-226.8 ng BMP-7/g DBM). The variability of BMP concentrations among different lots of the same DBM formulation, intra-product variability, was higher than the variability of concentrations among different DBM formulations, inter-product variability (coefficient of variation range BMP-2 [16.34% to 76.01%], P < 0.01; BMP-7 [3.71% to 82.08%], P < 0.001). BMP-4 was undetectable.
The relative quantities of BMPs in DBMs are low, in the order of 1 x 10(-9) g of BMP/g of DBM. There is higher variability in concentration of BMPs among 3 different lots of the same DBM formulation than among different DBM formulations. This variability questions DBM products' reliability and, possibly, efficacy in providing consistent osteoinduction. |
| doi_str_mv | 10.1097/01.brs.0000218581.92992.b7 |
| format | Article |
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To evaluate and compare the quantity of BMPs among several different DBM formulations (inter-product variability), as well as examine the variability of these proteins in different production lots within the same DBM formulation (intra-product variability).
DBMs are commonly used to augment available bone graft in spinal fusion procedures. Surgeons are presented with an ever-increasing variety of commercially available human DBMs from which to choose. Yet, there is limited information on a specific DBM product's osteoinductive efficacy, potency, and constancy.
There were protein extracts from each DBM sample separately dialyzed 4 times against distilled water at 4 degrees C for 48 hours. The amount of BMP-2, BMP-4, and BMP-7 was determined using enzyme-linked immunosorbent assay. RESULTS.: The concentrations of detected BMP-2 and BMP-7 were low for all DBM formulations, only nanograms of BMP were extracted from each gram of DBM (20.2-120.6 ng BMP-2/g DBM product; 54.2-226.8 ng BMP-7/g DBM). The variability of BMP concentrations among different lots of the same DBM formulation, intra-product variability, was higher than the variability of concentrations among different DBM formulations, inter-product variability (coefficient of variation range BMP-2 [16.34% to 76.01%], P < 0.01; BMP-7 [3.71% to 82.08%], P < 0.001). BMP-4 was undetectable.
The relative quantities of BMPs in DBMs are low, in the order of 1 x 10(-9) g of BMP/g of DBM. There is higher variability in concentration of BMPs among 3 different lots of the same DBM formulation than among different DBM formulations. This variability questions DBM products' reliability and, possibly, efficacy in providing consistent osteoinduction.</description><identifier>ISSN: 0362-2436</identifier><identifier>EISSN: 1528-1159</identifier><identifier>DOI: 10.1097/01.brs.0000218581.92992.b7</identifier><identifier>PMID: 16721289</identifier><identifier>CODEN: SPINDD</identifier><language>eng</language><publisher>Philadelphia, PA: Lippincott</publisher><subject>Biological and medical sciences ; Biological Products - chemistry ; Bone Demineralization Technique ; Bone Matrix - chemistry ; Bone Morphogenetic Protein 2 ; Bone Morphogenetic Protein 4 ; Bone Morphogenetic Protein 7 ; Bone Morphogenetic Proteins - analysis ; Cerebrospinal fluid. Meninges. Spinal cord ; Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases ; Drug toxicity and drugs side effects treatment ; Enzyme-Linked Immunosorbent Assay ; Growth Differentiation Factor 2 ; Growth Differentiation Factors ; Humans ; Medical sciences ; Nervous system (semeiology, syndromes) ; Neurology ; Osmolar Concentration ; Pharmacology. Drug treatments ; Toxicity: osteoarticular system ; Transforming Growth Factor beta - analysis</subject><ispartof>Spine (Philadelphia, Pa. 1976), 2006-05, Vol.31 (12), p.1299-1308</ispartof><rights>2006 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c376t-6fabc3d5428425304ec2f62b5e4eda5736663a8711400bb4a397a93c7c8cf2fa3</citedby><cites>FETCH-LOGICAL-c376t-6fabc3d5428425304ec2f62b5e4eda5736663a8711400bb4a397a93c7c8cf2fa3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17838614$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16721289$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>BAE, Hyun W</creatorcontrib><creatorcontrib>LI ZHAO</creatorcontrib><creatorcontrib>KANIM, Linda E. A</creatorcontrib><creatorcontrib>WONG, Pamela</creatorcontrib><creatorcontrib>DELAMARTER, Rick B</creatorcontrib><creatorcontrib>DAWSON, Edgar G</creatorcontrib><creatorcontrib>EINHORN, Thomas A</creatorcontrib><title>Intervariability and intravariability of bone morphogenetic proteins in commercially available demineralized bone matrix products</title><title>Spine (Philadelphia, Pa. 1976)</title><addtitle>Spine (Phila Pa 1976)</addtitle><description>Enzyme-linked immunosorbent assay was used to detect bone morphogenetic proteins (BMPs) 2, 4, and 7 in 9 commercially available ("off the shelf") demineralized bone matrix (DBM) product formulations using 3 different manufacturer's production lots of each DBM formulation.
To evaluate and compare the quantity of BMPs among several different DBM formulations (inter-product variability), as well as examine the variability of these proteins in different production lots within the same DBM formulation (intra-product variability).
DBMs are commonly used to augment available bone graft in spinal fusion procedures. Surgeons are presented with an ever-increasing variety of commercially available human DBMs from which to choose. Yet, there is limited information on a specific DBM product's osteoinductive efficacy, potency, and constancy.
There were protein extracts from each DBM sample separately dialyzed 4 times against distilled water at 4 degrees C for 48 hours. The amount of BMP-2, BMP-4, and BMP-7 was determined using enzyme-linked immunosorbent assay. RESULTS.: The concentrations of detected BMP-2 and BMP-7 were low for all DBM formulations, only nanograms of BMP were extracted from each gram of DBM (20.2-120.6 ng BMP-2/g DBM product; 54.2-226.8 ng BMP-7/g DBM). The variability of BMP concentrations among different lots of the same DBM formulation, intra-product variability, was higher than the variability of concentrations among different DBM formulations, inter-product variability (coefficient of variation range BMP-2 [16.34% to 76.01%], P < 0.01; BMP-7 [3.71% to 82.08%], P < 0.001). BMP-4 was undetectable.
The relative quantities of BMPs in DBMs are low, in the order of 1 x 10(-9) g of BMP/g of DBM. There is higher variability in concentration of BMPs among 3 different lots of the same DBM formulation than among different DBM formulations. This variability questions DBM products' reliability and, possibly, efficacy in providing consistent osteoinduction.</description><subject>Biological and medical sciences</subject><subject>Biological Products - chemistry</subject><subject>Bone Demineralization Technique</subject><subject>Bone Matrix - chemistry</subject><subject>Bone Morphogenetic Protein 2</subject><subject>Bone Morphogenetic Protein 4</subject><subject>Bone Morphogenetic Protein 7</subject><subject>Bone Morphogenetic Proteins - analysis</subject><subject>Cerebrospinal fluid. Meninges. Spinal cord</subject><subject>Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases</subject><subject>Drug toxicity and drugs side effects treatment</subject><subject>Enzyme-Linked Immunosorbent Assay</subject><subject>Growth Differentiation Factor 2</subject><subject>Growth Differentiation Factors</subject><subject>Humans</subject><subject>Medical sciences</subject><subject>Nervous system (semeiology, syndromes)</subject><subject>Neurology</subject><subject>Osmolar Concentration</subject><subject>Pharmacology. Drug treatments</subject><subject>Toxicity: osteoarticular system</subject><subject>Transforming Growth Factor beta - analysis</subject><issn>0362-2436</issn><issn>1528-1159</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpNkd1rFTEQxYNY7G31X5BF0Ldd87GbD9-kaC0UfLHPYZKd1Ug2e032lrZv_udN7cJ1XgaG3zkD5xDyjtGOUaM-Uta5XDpahzM9aNYZbgzvnHpBdmzgumVsMC_JjgrJW94LeUrOSvldeSmYeUVOmVSccW125O9VWjHfQg7gQgzrfQNpbEJaM_x_XKbGLQmbecn7X8tPTLgG3-zzsmJIpfKNX-YZsw8QY_W4hRDBRWxGnEPCDDE84Lh5wJrD3ZN4PPi1vCYnE8SCb7Z9Tm6-fvlx8a29_n55dfH5uvVCybWVEzgvxqHnuueDoD16PknuBuxxhEEJKaUArRjrKXWuB2EUGOGV137iE4hz8uHZtz7-c8Cy2jkUjzFCwuVQrNQ1nkHLCn56Bn1eSsk42X0OM-R7y6h9KsBSZmsB9liA_VeAdaqK325fDm7G8SjdEq_A-w2A4iFOGZIP5cgpLbRkvXgEcXCT9w</recordid><startdate>20060520</startdate><enddate>20060520</enddate><creator>BAE, Hyun W</creator><creator>LI ZHAO</creator><creator>KANIM, Linda E. A</creator><creator>WONG, Pamela</creator><creator>DELAMARTER, Rick B</creator><creator>DAWSON, Edgar G</creator><creator>EINHORN, Thomas A</creator><general>Lippincott</general><scope>IQODW</scope><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>20060520</creationdate><title>Intervariability and intravariability of bone morphogenetic proteins in commercially available demineralized bone matrix products</title><author>BAE, Hyun W ; LI ZHAO ; KANIM, Linda E. A ; WONG, Pamela ; DELAMARTER, Rick B ; DAWSON, Edgar G ; EINHORN, Thomas A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c376t-6fabc3d5428425304ec2f62b5e4eda5736663a8711400bb4a397a93c7c8cf2fa3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2006</creationdate><topic>Biological and medical sciences</topic><topic>Biological Products - chemistry</topic><topic>Bone Demineralization Technique</topic><topic>Bone Matrix - chemistry</topic><topic>Bone Morphogenetic Protein 2</topic><topic>Bone Morphogenetic Protein 4</topic><topic>Bone Morphogenetic Protein 7</topic><topic>Bone Morphogenetic Proteins - analysis</topic><topic>Cerebrospinal fluid. Meninges. Spinal cord</topic><topic>Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases</topic><topic>Drug toxicity and drugs side effects treatment</topic><topic>Enzyme-Linked Immunosorbent Assay</topic><topic>Growth Differentiation Factor 2</topic><topic>Growth Differentiation Factors</topic><topic>Humans</topic><topic>Medical sciences</topic><topic>Nervous system (semeiology, syndromes)</topic><topic>Neurology</topic><topic>Osmolar Concentration</topic><topic>Pharmacology. Drug treatments</topic><topic>Toxicity: osteoarticular system</topic><topic>Transforming Growth Factor beta - analysis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>BAE, Hyun W</creatorcontrib><creatorcontrib>LI ZHAO</creatorcontrib><creatorcontrib>KANIM, Linda E. A</creatorcontrib><creatorcontrib>WONG, Pamela</creatorcontrib><creatorcontrib>DELAMARTER, Rick B</creatorcontrib><creatorcontrib>DAWSON, Edgar G</creatorcontrib><creatorcontrib>EINHORN, Thomas A</creatorcontrib><collection>Pascal-Francis</collection><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>Spine (Philadelphia, Pa. 1976)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>BAE, Hyun W</au><au>LI ZHAO</au><au>KANIM, Linda E. A</au><au>WONG, Pamela</au><au>DELAMARTER, Rick B</au><au>DAWSON, Edgar G</au><au>EINHORN, Thomas A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Intervariability and intravariability of bone morphogenetic proteins in commercially available demineralized bone matrix products</atitle><jtitle>Spine (Philadelphia, Pa. 1976)</jtitle><addtitle>Spine (Phila Pa 1976)</addtitle><date>2006-05-20</date><risdate>2006</risdate><volume>31</volume><issue>12</issue><spage>1299</spage><epage>1308</epage><pages>1299-1308</pages><issn>0362-2436</issn><eissn>1528-1159</eissn><coden>SPINDD</coden><abstract>Enzyme-linked immunosorbent assay was used to detect bone morphogenetic proteins (BMPs) 2, 4, and 7 in 9 commercially available ("off the shelf") demineralized bone matrix (DBM) product formulations using 3 different manufacturer's production lots of each DBM formulation.
To evaluate and compare the quantity of BMPs among several different DBM formulations (inter-product variability), as well as examine the variability of these proteins in different production lots within the same DBM formulation (intra-product variability).
DBMs are commonly used to augment available bone graft in spinal fusion procedures. Surgeons are presented with an ever-increasing variety of commercially available human DBMs from which to choose. Yet, there is limited information on a specific DBM product's osteoinductive efficacy, potency, and constancy.
There were protein extracts from each DBM sample separately dialyzed 4 times against distilled water at 4 degrees C for 48 hours. The amount of BMP-2, BMP-4, and BMP-7 was determined using enzyme-linked immunosorbent assay. RESULTS.: The concentrations of detected BMP-2 and BMP-7 were low for all DBM formulations, only nanograms of BMP were extracted from each gram of DBM (20.2-120.6 ng BMP-2/g DBM product; 54.2-226.8 ng BMP-7/g DBM). The variability of BMP concentrations among different lots of the same DBM formulation, intra-product variability, was higher than the variability of concentrations among different DBM formulations, inter-product variability (coefficient of variation range BMP-2 [16.34% to 76.01%], P < 0.01; BMP-7 [3.71% to 82.08%], P < 0.001). BMP-4 was undetectable.
The relative quantities of BMPs in DBMs are low, in the order of 1 x 10(-9) g of BMP/g of DBM. There is higher variability in concentration of BMPs among 3 different lots of the same DBM formulation than among different DBM formulations. This variability questions DBM products' reliability and, possibly, efficacy in providing consistent osteoinduction.</abstract><cop>Philadelphia, PA</cop><cop>Hagerstown, MD</cop><pub>Lippincott</pub><pmid>16721289</pmid><doi>10.1097/01.brs.0000218581.92992.b7</doi><tpages>10</tpages></addata></record> |
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| subjects | Biological and medical sciences Biological Products - chemistry Bone Demineralization Technique Bone Matrix - chemistry Bone Morphogenetic Protein 2 Bone Morphogenetic Protein 4 Bone Morphogenetic Protein 7 Bone Morphogenetic Proteins - analysis Cerebrospinal fluid. Meninges. Spinal cord Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases Drug toxicity and drugs side effects treatment Enzyme-Linked Immunosorbent Assay Growth Differentiation Factor 2 Growth Differentiation Factors Humans Medical sciences Nervous system (semeiology, syndromes) Neurology Osmolar Concentration Pharmacology. Drug treatments Toxicity: osteoarticular system Transforming Growth Factor beta - analysis |
| title | Intervariability and intravariability of bone morphogenetic proteins in commercially available demineralized bone matrix products |
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