Bone Augmentation of Atrophic Alveolar Ridges Using a Synthetic Bone Substitute With Mesenchymal Stem Cells: A Randomized, Controlled Clinical Trial

Sanz, Mariano; Gjerde, Cecilie Gudveig; Gjertsen, Bjørn T; Ortiz-Vigón, Alberto; SANCHEZ PEREZ, NEREA; HOORNAERT, ALAIN; Caballé-Serrano, Jordi; Giralt Hernando, Maria; Gaultier, Frederick; Reinald, Nicoleta; Pinholt, Else M.; Rojewski, Markus; Rouard, Helen; Chevallier, Nathalie; Mohamed-Ahmed, Samih; Shi, Xieqi; Shi, Tie-Jun; Schrezenmeier, Hubert; Layrolle, Pierre; Mustafa, Kamal

Bone Augmentation of Atrophic Alveolar Ridges Using a Synthetic Bone Substitute With Mesenchymal Stem Cells: A Randomized, Controlled Clinical Trial

This manuscript presents the regenerative outcomes of a multicenter phase 2 randomized clinical trial funded by the European Union throughthe H2020 project titled “Personalised Maxillofacial Bone Regeneration, the Maxibone Project” (Grant Agreement ID: 779322; H2020- SC1-2017- Single-Stage-RTD) with...

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Detalles Bibliográficos
Autores:	Sanz, Mariano, Gjerde, Cecilie Gudveig, Gjertsen, Bjørn T, Ortiz-Vigón, Alberto, SANCHEZ PEREZ, NEREA, HOORNAERT, ALAIN, Caballé-Serrano, Jordi, Giralt Hernando, Maria, Gaultier, Frederick, Reinald, Nicoleta, Pinholt, Else M., Rojewski, Markus, Rouard, Helen, Chevallier, Nathalie, Mohamed-Ahmed, Samih, Shi, Xieqi, Shi, Tie-Jun, Schrezenmeier, Hubert, Layrolle, Pierre, Mustafa, Kamal
Tipo de recurso:	artículo
Fecha de publicación:	2025
País:	España
Institución:	Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:	Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:	oai:recercat.cat:20.500.12328/5130
Acceso en línea:	http://hdl.handle.net/20.500.12328/5130 https://dx.doi.org/10.1111/clr.70025
Access Level:	acceso abierto
Palabra clave:	Alveolar ridge augmentation Bone regeneration Cell therapy Mesenchymal cells dental implants Aumento de la cresta alveolar Regeneración ósea Terapia celular Células mesenquimales Implantes dentales Augment de la cresta alveolar Regeneració òssia Teràpia cel·lular cèl·lules mesenquimàtiques Implants dentals 616.3

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spelling	Bone Augmentation of Atrophic Alveolar Ridges Using a Synthetic Bone Substitute With Mesenchymal Stem Cells: A Randomized, Controlled Clinical TrialSanz, MarianoGjerde, Cecilie GudveigGjertsen, Bjørn TOrtiz-Vigón, AlbertoSANCHEZ PEREZ, NEREAHOORNAERT, ALAINCaballé-Serrano, JordiGiralt Hernando, MariaGaultier, FrederickReinald, NicoletaPinholt, Else M.Rojewski, MarkusRouard, HelenChevallier, NathalieMohamed-Ahmed, SamihShi, XieqiShi, Tie-JunSchrezenmeier, HubertLayrolle, PierreMustafa, KamalAlveolar ridge augmentationBone regenerationCell therapyMesenchymal cells dental implantsAumento de la cresta alveolarRegeneración óseaTerapia celularCélulas mesenquimalesImplantes dentalesAugment de la cresta alveolarRegeneració òssiaTeràpia cel·lularcèl·lules mesenquimàtiquesImplants dentals616.3This manuscript presents the regenerative outcomes of a multicenter phase 2 randomized clinical trial funded by the European Union throughthe H2020 project titled “Personalised Maxillofacial Bone Regeneration, the Maxibone Project” (Grant Agreement ID: 779322; H2020- SC1-2017- Single-Stage-RTD) with EudraCT number 2018- 001227-39Objectives: To assess the efficacy and safety of a cell-based therapy for 3D bone augmentation of severe alveolar bone defectsprior to dental implant placement.Materials and Methods: A Phase 2 randomized controlled clinical trial evaluated the safety and efficacy of a cell therapy usingexpanded autologous iliac crest-derived mesenchymal cells seeded on a synthetic bioabsorbable bone substitute covered with anon-resorbable membrane. The control group received an autogenous bone block graft. After 5 months, CBCT scans were com-pared to measure the bone volume changes achieved after the regenerative surgery. Subsequently, dental implants were placedin the regenerated areas.Results: A total of 48 patients were included and randomized (36 patients in the test group and 12 in the control group). However,seven patients did not reach the minimum required number of expanded MSCs and were therefore unable to be treated. Thetested intervention demonstrated significantly greater gains in bone volume, with a mean difference of 480.01 mm 3 (p = 0.032).Similarly, the mean change in bone crest volume from baseline to 5 months was notably higher in the test group (1066.91 mm 3) compared to the control group (586.9 mm 3). Adverse reactions and patient morbidity were minor in both groups. Implants wereplaced on the regenerated bone, and all were integrated successfully in both groups.Conclusions: The cell-based therapy resulted in significant changes in bone volume compared to the control treatment, ena-bling dental implants in all patients. The procedure was associated with minimal adverse effects and patient morbidity.Trial Registration: ClinicalTrials.gov: NCT03373052, NCT04297813info:eu-repo/semantics/publishedVersionWiley2025info:eu-repo/semantics/article17http://hdl.handle.net/20.500.12328/5130https://dx.doi.org/10.1111/clr.70025reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésClinical Oral Implants Research779322/European Union© 2025 The Author(s). Clinical Oral Implants Research published by John Wiley & Sons Ltd.https://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:20.500.12328/51302026-05-29T05:05:01Z
dc.title.none.fl_str_mv	Bone Augmentation of Atrophic Alveolar Ridges Using a Synthetic Bone Substitute With Mesenchymal Stem Cells: A Randomized, Controlled Clinical Trial
title	Bone Augmentation of Atrophic Alveolar Ridges Using a Synthetic Bone Substitute With Mesenchymal Stem Cells: A Randomized, Controlled Clinical Trial
spellingShingle	Bone Augmentation of Atrophic Alveolar Ridges Using a Synthetic Bone Substitute With Mesenchymal Stem Cells: A Randomized, Controlled Clinical Trial Sanz, Mariano Alveolar ridge augmentation Bone regeneration Cell therapy Mesenchymal cells dental implants Aumento de la cresta alveolar Regeneración ósea Terapia celular Células mesenquimales Implantes dentales Augment de la cresta alveolar Regeneració òssia Teràpia cel·lular cèl·lules mesenquimàtiques Implants dentals 616.3
title_short	Bone Augmentation of Atrophic Alveolar Ridges Using a Synthetic Bone Substitute With Mesenchymal Stem Cells: A Randomized, Controlled Clinical Trial
title_full	Bone Augmentation of Atrophic Alveolar Ridges Using a Synthetic Bone Substitute With Mesenchymal Stem Cells: A Randomized, Controlled Clinical Trial
title_fullStr	Bone Augmentation of Atrophic Alveolar Ridges Using a Synthetic Bone Substitute With Mesenchymal Stem Cells: A Randomized, Controlled Clinical Trial
title_full_unstemmed	Bone Augmentation of Atrophic Alveolar Ridges Using a Synthetic Bone Substitute With Mesenchymal Stem Cells: A Randomized, Controlled Clinical Trial
title_sort	Bone Augmentation of Atrophic Alveolar Ridges Using a Synthetic Bone Substitute With Mesenchymal Stem Cells: A Randomized, Controlled Clinical Trial
dc.creator.none.fl_str_mv	Sanz, Mariano Gjerde, Cecilie Gudveig Gjertsen, Bjørn T Ortiz-Vigón, Alberto SANCHEZ PEREZ, NEREA HOORNAERT, ALAIN Caballé-Serrano, Jordi Giralt Hernando, Maria Gaultier, Frederick Reinald, Nicoleta Pinholt, Else M. Rojewski, Markus Rouard, Helen Chevallier, Nathalie Mohamed-Ahmed, Samih Shi, Xieqi Shi, Tie-Jun Schrezenmeier, Hubert Layrolle, Pierre Mustafa, Kamal
author	Sanz, Mariano
author_facet	Sanz, Mariano Gjerde, Cecilie Gudveig Gjertsen, Bjørn T Ortiz-Vigón, Alberto SANCHEZ PEREZ, NEREA HOORNAERT, ALAIN Caballé-Serrano, Jordi Giralt Hernando, Maria Gaultier, Frederick Reinald, Nicoleta Pinholt, Else M. Rojewski, Markus Rouard, Helen Chevallier, Nathalie Mohamed-Ahmed, Samih Shi, Xieqi Shi, Tie-Jun Schrezenmeier, Hubert Layrolle, Pierre Mustafa, Kamal
author_role	author
author2	Gjerde, Cecilie Gudveig Gjertsen, Bjørn T Ortiz-Vigón, Alberto SANCHEZ PEREZ, NEREA HOORNAERT, ALAIN Caballé-Serrano, Jordi Giralt Hernando, Maria Gaultier, Frederick Reinald, Nicoleta Pinholt, Else M. Rojewski, Markus Rouard, Helen Chevallier, Nathalie Mohamed-Ahmed, Samih Shi, Xieqi Shi, Tie-Jun Schrezenmeier, Hubert Layrolle, Pierre Mustafa, Kamal
author2_role	author author author author author author author author author author author author author author author author author author author
dc.subject.none.fl_str_mv	Alveolar ridge augmentation Bone regeneration Cell therapy Mesenchymal cells dental implants Aumento de la cresta alveolar Regeneración ósea Terapia celular Células mesenquimales Implantes dentales Augment de la cresta alveolar Regeneració òssia Teràpia cel·lular cèl·lules mesenquimàtiques Implants dentals 616.3
topic	Alveolar ridge augmentation Bone regeneration Cell therapy Mesenchymal cells dental implants Aumento de la cresta alveolar Regeneración ósea Terapia celular Células mesenquimales Implantes dentales Augment de la cresta alveolar Regeneració òssia Teràpia cel·lular cèl·lules mesenquimàtiques Implants dentals 616.3
description	This manuscript presents the regenerative outcomes of a multicenter phase 2 randomized clinical trial funded by the European Union throughthe H2020 project titled “Personalised Maxillofacial Bone Regeneration, the Maxibone Project” (Grant Agreement ID: 779322; H2020- SC1-2017- Single-Stage-RTD) with EudraCT number 2018- 001227-39
publishDate	2025
dc.date.none.fl_str_mv	2025
dc.type.none.fl_str_mv	info:eu-repo/semantics/article
format	article
dc.identifier.none.fl_str_mv	http://hdl.handle.net/20.500.12328/5130 https://dx.doi.org/10.1111/clr.70025
url	http://hdl.handle.net/20.500.12328/5130 https://dx.doi.org/10.1111/clr.70025
dc.language.none.fl_str_mv	Inglés
language_invalid_str_mv	Inglés
dc.relation.none.fl_str_mv	Clinical Oral Implants Research 779322/European Union
dc.rights.none.fl_str_mv	© 2025 The Author(s). Clinical Oral Implants Research published by John Wiley & Sons Ltd. https://creativecommons.org/licenses/by-nc/4.0/ info:eu-repo/semantics/openAccess
rights_invalid_str_mv	© 2025 The Author(s). Clinical Oral Implants Research published by John Wiley & Sons Ltd. https://creativecommons.org/licenses/by-nc/4.0/
eu_rights_str_mv	openAccess
dc.format.none.fl_str_mv	17
dc.publisher.none.fl_str_mv	Wiley
publisher.none.fl_str_mv	Wiley
dc.source.none.fl_str_mv	reponame:Recercat. Dipósit de la Recerca de Catalunya instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str	Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str	Recercat. Dipósit de la Recerca de Catalunya
collection	Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score	15,81155

Bone Augmentation of Atrophic Alveolar Ridges Using a Synthetic Bone Substitute With Mesenchymal Stem Cells: A Randomized, Controlled Clinical Trial

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