{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T17:33:27Z","timestamp":1789148007202,"version":"build-2803163510"},"reference-count":78,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2026,1,29]],"date-time":"2026-01-29T00:00:00Z","timestamp":1769644800000},"content-version":"vor","delay-in-days":28,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,1,1]],"date-time":"2026-01-01T00:00:00Z","timestamp":1767225600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Tissue Engineering and Regenerative Medicine"],"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Reconstruction of critical\u2010sized bone defects, particularly in the cranio\u2010maxillofacial region, presents unique challenges due to the need for integration with adjacent well\u2010vascularized tissue and the absence of significant load\u2010bearing requirements. This study evaluated the clinical readiness of bone tissue engineering (BTE) for critically sized cranial defects using custom 3D\u2010printed hydroxyapatite scaffolds augmented with either recombinant human bone morphogenetic protein\u20102 (rhBMP\u20102) or dipyridamole (DIPY) in a highly translational nonhuman primate model.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Identical 5\u2009\u00d7\u20095\u2010cm vertex guided craniotomies were created in 12 macaques: Three cynomolgus macaques served as negative controls to validate the critical size nature of the defect, while nine rhesus macaques underwent scaffold reconstruction. Subjects were divided into three groups: uncoated scaffolds (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20093), scaffolds augmented with rhBMP\u20102 (Infuse\u00ae Medtronic,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20093), and scaffolds coated with DIPY, an adenosine A\n                      <jats:sub>2A<\/jats:sub>\n                      receptor (A\n                      <jats:sub>2A<\/jats:sub>\n                      R) indirect agonist (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20093). Bone growth and integration were assessed over 12\u2009months through serial CT scans, followed by ex vivo micro\u2010CT scanning, histology, and nanoindentation testing.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Negative control subjects did not demonstrate new bone formation, confirming the critical defect model. Subjects treated with scaffolds through all treatment groups remained intact throughout the 12\u2010month follow\u2010up. The rhBMP\u20102\u2010treated group exhibited bridging, \u223c90% circumferentially, significantly greater than DIPY (\u223c9%) or the uncoated scaffold (10%) (\n                      <jats:italic>p<\/jats:italic>\n                      &lt; 0.001). Bone volume within rhBMP\u20102\u2010treated scaffolds (7621\u2009\u00b1\u2009145\u2009mm\n                      <jats:sup>3<\/jats:sup>\n                      ) significantly exceeded that of DIPY (6466\u2009\u00b1\u2009693\u2009mm\n                      <jats:sup>3<\/jats:sup>\n                      ,\n                      <jats:italic>p<\/jats:italic>\n                      = 0.03) and uncoated scaffold (6348\u2009\u00b1\u2009663\u2009mm\n                      <jats:sup>3<\/jats:sup>\n                      ,\n                      <jats:italic>p<\/jats:italic>\n                      = 0.02) groups at 12\u2009months. Quantitative histological micrograph analysis demonstrated that rhBMP\u20102 scaffolds were associated with the highest bone ingrowth (\u223c64%) relative to DIPY (\u223c39%) and uncoated scaffolds (\u223c27%). Nanoindentation yielded superior mechanical properties (Young\u2019s modulus and hardness) of newly generated bone with defects treated with rhBMP\u20102 scaffolds (\n                      <jats:italic>p<\/jats:italic>\n                      &lt; 0.05).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Reconstructing critically sized cranial defects with custom 3D\u2010printed hydroxyapatite scaffolds was successful and yielded favorable results in this model. Scaffolds augmented with rhBMP\u20102 demonstrated superior bone ingrowth, integration, and mechanical properties, highlighting their potential as a viable alternative to autografts and allograft materials for cranioplasty.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1155\/term\/2466910","type":"journal-article","created":{"date-parts":[[2026,1,30]],"date-time":"2026-01-30T06:53:26Z","timestamp":1769756006000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Cranial Defect Reconstruction With Custom 3D\u2010Printed Hydroxyapatite Scaffolds Augmented With rhBMP\u20102 or Dipyridamole in a Nonhuman Primate Model"],"prefix":"10.1155","volume":"2026","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0657-3750","authenticated-orcid":false,"given":"Griffin P.","family":"Bins","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heather A.","family":"Burkart","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Molair","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samuel","family":"Kogan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dominic A.","family":"Massary","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-4659-6087","authenticated-orcid":false,"given":"Angel Cabrera","family":"Pereira","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adem","family":"Aksu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank","family":"Reinauer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-8737-1299","authenticated-orcid":false,"given":"Daniel A.","family":"Couture","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1458-6527","authenticated-orcid":false,"given":"Lukasz","family":"Witek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3985-7250","authenticated-orcid":false,"given":"Christopher M.","family":"Runyan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,1,29]]},"reference":[{"key":"e_1_2_10_1_2","doi-asserted-by":"crossref","first-page":"S7","DOI":"10.1097\/BOT.0000000000001115","article-title":"Critical-Size Bone Defects: Is There a Consensus for Diagnosis and Treatment?","author":"Nauth A.","year":"2018","journal-title":"Journal of Orthopaedics and Trauma"},{"key":"e_1_2_10_2_2","doi-asserted-by":"crossref","DOI":"10.4103\/sni.sni_388_17","article-title":"Cranial Autologous Bone Flap Resorption After a Cranioplasty: A Case Report","volume":"9","author":"De Fran\u00e7a S.","year":"2018","journal-title":"Surgical Neurology International"},{"key":"e_1_2_10_3_2","doi-asserted-by":"crossref","first-page":"1915","DOI":"10.1007\/s10143-022-01737-z","article-title":"A Systematic Review and Meta-Analysis of Factors Involved in Bone Flap Resorption After Decompressive Craniectomy","volume":"45","author":"Signorelli F.","year":"2022","journal-title":"Neurosurgical Review"},{"key":"e_1_2_10_4_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10561-020-09897-2"},{"key":"e_1_2_10_5_2","doi-asserted-by":"crossref","DOI":"10.1097\/PRS.0000000000002941","article-title":"Autogenous Bone Reconstruction of Large Secondary Skull Defects","volume":"139","author":"Fearon J. 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