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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Follow-Up of Implant Survival Comparing Ficoll and Bone Marrow Aspirate Concentrate Methods for Hard Tissue Regeneration with Mesenchymal Stem Cells in Humans</title><author><name sortKey="Duttenhoefer, Fabian" sort="Duttenhoefer, Fabian" uniqKey="Duttenhoefer F" first="Fabian" last="Duttenhoefer">Fabian Duttenhoefer</name></author><author><name sortKey="Hieber, Stefan F" sort="Hieber, Stefan F" uniqKey="Hieber S" first="Stefan F." last="Hieber">Stefan F. Hieber</name></author><author><name sortKey="Stricker, Andres" sort="Stricker, Andres" uniqKey="Stricker A" first="Andres" last="Stricker">Andres Stricker</name></author><author><name sortKey="Schmelzeisen, Rainer" sort="Schmelzeisen, Rainer" uniqKey="Schmelzeisen R" first="Rainer" last="Schmelzeisen">Rainer Schmelzeisen</name></author><author><name sortKey="Gutwald, Ralf" sort="Gutwald, Ralf" uniqKey="Gutwald R" first="Ralf" last="Gutwald">Ralf Gutwald</name></author><author><name sortKey="Sauerbier, Sebastian" sort="Sauerbier, Sebastian" uniqKey="Sauerbier S" first="Sebastian" last="Sauerbier">Sebastian Sauerbier</name></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">24804168</idno><idno type="pmc">3995205</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3995205</idno><idno type="RBID">PMC:3995205</idno><idno type="doi">10.1089/biores.2014.0003</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">002951</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">002951</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Follow-Up of Implant Survival Comparing Ficoll and Bone Marrow Aspirate Concentrate Methods for Hard Tissue Regeneration with Mesenchymal Stem Cells in Humans</title><author><name sortKey="Duttenhoefer, Fabian" sort="Duttenhoefer, Fabian" uniqKey="Duttenhoefer F" first="Fabian" last="Duttenhoefer">Fabian Duttenhoefer</name></author><author><name sortKey="Hieber, Stefan F" sort="Hieber, Stefan F" uniqKey="Hieber S" first="Stefan F." last="Hieber">Stefan F. Hieber</name></author><author><name sortKey="Stricker, Andres" sort="Stricker, Andres" uniqKey="Stricker A" first="Andres" last="Stricker">Andres Stricker</name></author><author><name sortKey="Schmelzeisen, Rainer" sort="Schmelzeisen, Rainer" uniqKey="Schmelzeisen R" first="Rainer" last="Schmelzeisen">Rainer Schmelzeisen</name></author><author><name sortKey="Gutwald, Ralf" sort="Gutwald, Ralf" uniqKey="Gutwald R" first="Ralf" last="Gutwald">Ralf Gutwald</name></author><author><name sortKey="Sauerbier, Sebastian" sort="Sauerbier, Sebastian" uniqKey="Sauerbier S" first="Sebastian" last="Sauerbier">Sebastian Sauerbier</name></author></analytic><series><title level="j">BioResearch Open Access</title><idno type="ISSN">2164-7844</idno><idno type="eISSN">2164-7860</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><title>Abstract</title><p><bold><italic>Objective:</italic></bold> Clinical follow-up of implant survival in 11 patients comparing two different methods for mesenchymal stem cell (MSC) isolation (Ficoll and bone marrow aspirate concentrate [BMAC]) applied in maxillary sinus augmentation.</p><p><bold><italic>Methods:</italic></bold> Mononuclear cells, including MSCs, were concentrated with either Ficoll (control group, <italic>n</italic>=6 sinus) or BMAC (test group, <italic>n</italic>=12 sinus) and transplanted in combination with bovine bone mineral. A total of 50 implants were placed in a second surgical intervention (17 Ficoll/33 BMAC) and loaded after 4 months. Overall implant survival was assessed with a Kaplan-Meier model using package survival under R.</p><p><bold><italic>Results:</italic></bold> Implant survival of the Ficoll group was 100% compared with the BMAC group, which had 93.4% survival (95% confidence interval, 0.849–1). The difference between the groups was not significant (<italic>p</italic>=0.381).</p><p><bold><italic>Conclusion:</italic></bold> The BMAC system is an effective and suitable “chair-side” method for clinical application in hard tissue regeneration.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Duttenhoefer, F" uniqKey="Duttenhoefer F">F Duttenhoefer</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Smiler, D" uniqKey="Smiler D">D Smiler</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Sauerbier, S" uniqKey="Sauerbier S">S Sauerbier</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Hermann, Pc" uniqKey="Hermann P">PC Hermann</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Wongchuensoontorn, C" uniqKey="Wongchuensoontorn C">C Wongchuensoontorn</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Buser, D" uniqKey="Buser D">D Buser</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Therneau, Tm" uniqKey="Therneau T">TM Therneau</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Rickert, D" uniqKey="Rickert D">D Rickert</name></author></analytic></biblStruct></listBibl></div1></back></TEI><pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Biores Open Access</journal-id><journal-id journal-id-type="iso-abbrev">Biores Open Access</journal-id><journal-id journal-id-type="publisher-id">biores</journal-id><journal-title-group><journal-title>BioResearch Open Access</journal-title></journal-title-group><issn pub-type="ppub">2164-7844</issn><issn pub-type="epub">2164-7860</issn><publisher><publisher-name>Mary Ann Liebert, Inc.</publisher-name><publisher-loc>140 Huguenot Street, 3rd FloorNew Rochelle, NY 10801USA</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">24804168</article-id><article-id pub-id-type="pmc">3995205</article-id><article-id pub-id-type="publisher-id">10.1089/biores.2014.0003</article-id><article-id pub-id-type="doi">10.1089/biores.2014.0003</article-id><article-categories><subj-group subj-group-type="heading"><subject>Technical Report</subject></subj-group></article-categories><title-group><article-title>Follow-Up of Implant Survival Comparing Ficoll and Bone Marrow Aspirate Concentrate Methods for Hard Tissue Regeneration with Mesenchymal Stem Cells in Humans</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Duttenhoefer</surname><given-names>Fabian</given-names></name></contrib><contrib contrib-type="author"><name><surname>Hieber</surname><given-names>Stefan F.</given-names></name></contrib><contrib contrib-type="author"><name><surname>Stricker</surname><given-names>Andres</given-names></name></contrib><contrib contrib-type="author"><name><surname>Schmelzeisen</surname><given-names>Rainer</given-names></name></contrib><contrib contrib-type="author"><name><surname>Gutwald</surname><given-names>Ralf</given-names></name></contrib><contrib contrib-type="author"><name><surname>Sauerbier</surname><given-names>Sebastian</given-names></name></contrib><aff id="aff1">Department of Oral and Craniomaxillofacial Surgery,<institution>University Hospital Freiburg</institution>, Freiburg,<country>Germany</country>.</aff></contrib-group><author-notes><corresp><addr-line>Address correspondence to:</addr-line><addr-line><italic>Fabian Duttenhoefer, MD</italic></addr-line><institution><italic>Universitätsklinik für Zahn-, Mund- und Kieferheilkunde</italic></institution><addr-line><italic>Abteilung Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie</italic></addr-line><addr-line><italic>Hugstetter Str. 55</italic></addr-line><addr-line><italic>D-79106 Freiburg</italic></addr-line><country>Germany</country><break></break><italic>E-mail:</italic><email xlink:href="mailto:fabian.duttenhoefer@uniklinik-freiburg.de">fabian.duttenhoefer@uniklinik-freiburg.de</email></corresp></author-notes><pub-date pub-type="ppub"><day>01</day><month>4</month><year>2014</year><pmc-comment>string-date: April 2014</pmc-comment>
</pub-date><pub-date pub-type="pmc-release"><day>01</day><month>4</month><year>2014</year><pmc-comment>string-date: April 2014</pmc-comment>
</pub-date><pmc-comment> PMC Release delay is 0 months and 0 days and was based on the
<volume>3</volume><issue>2</issue><fpage>75</fpage><lpage>76</lpage><permissions><copyright-statement>Copyright 2014, Mary Ann Liebert, Inc.</copyright-statement><copyright-year>2014</copyright-year></permissions><self-uri content-type="pdf" xlink:type="simple" xlink:href="biores.2014.0003.pdf"></self-uri><abstract><title>Abstract</title><p><bold><italic>Objective:</italic></bold> Clinical follow-up of implant survival in 11 patients comparing two different methods for mesenchymal stem cell (MSC) isolation (Ficoll and bone marrow aspirate concentrate [BMAC]) applied in maxillary sinus augmentation.</p><p><bold><italic>Methods:</italic></bold> Mononuclear cells, including MSCs, were concentrated with either Ficoll (control group, <italic>n</italic>=6 sinus) or BMAC (test group, <italic>n</italic>=12 sinus) and transplanted in combination with bovine bone mineral. A total of 50 implants were placed in a second surgical intervention (17 Ficoll/33 BMAC) and loaded after 4 months. Overall implant survival was assessed with a Kaplan-Meier model using package survival under R.</p><p><bold><italic>Results:</italic></bold> Implant survival of the Ficoll group was 100% compared with the BMAC group, which had 93.4% survival (95% confidence interval, 0.849–1). The difference between the groups was not significant (<italic>p</italic>=0.381).</p><p><bold><italic>Conclusion:</italic></bold> The BMAC system is an effective and suitable “chair-side” method for clinical application in hard tissue regeneration.</p></abstract><kwd-group kwd-group-type="author"><title><bold>Key words:</bold> </title><kwd>biomaterials</kwd><kwd>cell culture</kwd><kwd>tissue engineering</kwd></kwd-group><counts><fig-count count="1"></fig-count><ref-count count="8"></ref-count><page-count count="2"></page-count></counts></article-meta></front><body><sec sec-type="intro" id="s001"><title>Introduction</title><p>A<sc>prevalent modality to increase</sc> the amount of available bone prior to implantation is grafting of the maxillary sinus.<sup><xref rid="B1" ref-type="bibr">1</xref></sup> Over the last decade the application of concentrated mononuclear cells, including mesenchymal stem cells (MSCs), has emerged as a promising alternative for bone regeneration in the field of oral and cranio-maxillofacial surgery.<sup><xref rid="B2" ref-type="bibr">2</xref>,<xref rid="B3" ref-type="bibr">3</xref></sup> However, conventional open cell-concentration systems are restricted to good manufacturing practice conditions and thus clinically impractical.<sup><xref rid="B4" ref-type="bibr">4</xref>,<xref rid="B5" ref-type="bibr">5</xref></sup></p><p>The present study evaluates implant survival in a clinical follow-up of 11 patients who were involved in the study of Sauerbier et al.<sup><xref rid="B3" ref-type="bibr">3</xref></sup> on new bone formation in the maxillary sinus. Patients requiring dental implant placement in the posterior maxilla with a maximum of 3 mm of residual bone received sinus augmentation with bovine bone mineral (BBM) particles and MSCs, isolated with either the Ficoll method or the closed, chair-side bone marrow aspirate concentrate (BMAC) method. Successful tissue regeneration was assumed on the basis of implant survival after up to 2.5 years of loading.</p></sec><sec sec-type="materials|methods" id="s002"><title>Materials and Methods</title><p>The study protocol and sinus augmentation procedure is described in detail by Sauerbier et al.<sup><xref rid="B3" ref-type="bibr">3</xref></sup> In brief, bone marrow was obtained with a bone marrow biopsy needle from the pelvic bone latero-caudal from the superior posterior iliac spine. Aspirates were either given to the laboratory to separate the mononucleated cells with the Ficoll-method or directly processed in the operating room using the BMAC method according to manufacturer's instructions.</p><p>Sinuses were augmented with BBM enriched with mononucleated cells in thrombin, and covered with a collagen membrane. After a 3-month healing time, a total of 50 implants (17 Ficoll, 33 BMAC) were placed in a second-stage procedure and allowed to osseointegrate for an additional 4 months before prosthetic loading. Implant survival was clinically evaluated, according to the modified parameters described by Buser et al.,<sup><xref rid="B6" ref-type="bibr">6</xref></sup> in the patient follow-up, up to 2.5 years.</p><p>Implant survival was analyzed by a Kaplan-Meier model using package survival under R.<sup><xref rid="B7" ref-type="bibr">7</xref></sup></p></sec><sec sec-type="results" id="s003"><title>Results</title><p>In the first stage of the study, no patients dropped out and all recovered well from the surgical procedures. None of the 17 implants of the Ficoll-group were lost, and only one implant out of 33 failed in the BMAC group before prosthetic loading (<xref ref-type="fig" rid="f1">Fig. 1</xref>). After loading, 49 implants osseointegrated and remained functional. Implant survival of the Ficoll group was 100% compared with the BMAC group, which had 93.4% survival (95% confidence interval, 0.849–1). The difference between the groups was not significant (<italic>p</italic>=0.381).</p><fig id="f1" fig-type="figure" orientation="portrait" position="float"><label><bold>FIG. 1.</bold></label><caption><p>Kaplan-Meier plots of implant survival with 95% confidence intervals of implant survival for bone marrow aspirate concentrate (BMAC). Confidence intervals for Ficoll are not defined for this model because there were no events. Implants at risk are indicated at the bottom.</p></caption><graphic xlink:href="fig-1"></graphic></fig></sec><sec sec-type="discussion" id="s004"><title>Discussion</title><p>Results of the present study on implant survival show that the difference between the clinically feasible BMAC method was not significantly (<italic>p</italic>=0.381) different from the approved, but clinically impractical Ficoll method. Similar results were observed in the split mouth study of Rickert et al.,<sup><xref rid="B8" ref-type="bibr">8</xref></sup> in which sinus augmentation with the BMAC method was compared with the conventional method, which involves biomaterial being mixed with autologous bone. In that study, 91% of the dental implants osseointegrated in the BMAC site, whereas 100% osseointegrated in the control. As in the present study, no implants were lost after functional loading.<sup><xref rid="B8" ref-type="bibr">8</xref></sup></p></sec><sec sec-type="conclusion" id="s005"><title>Conclusion</title><p>This study indicates that the BMAC method is a clinically effective and a suitable chair-side alternative to the established Ficoll method for hard tissue regeneration.</p></sec></body><back><sec id="s006" sec-type="ack"><title>Acknowledgments</title><p>This study received technical support from Harvest Technologies and Geistlich Biomaterials. 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