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Materials 2018, 11(8), 1349; https://doi.org/10.3390/ma11081349

Preclinical Studies of the Biosafety and Efficacy of Human Bone Marrow Mesenchymal Stem Cells Pre-Seeded into β-TCP Scaffolds after Transplantation

1
Cell Therapy Unit, IMIB-University Hospital Virgen de la Arrixaca, Faculty of Medicin, University of Murcia, 30120 Murcia, Spain
2
Service of Oral and Maxillofacial Surgery, Clinical University Hospital Virgen de la Arrixaca, 30120 Murcia, Spain
3
Inflammation and Experimental Surgery Unit, CIBERehd, Institute for Bio-Health Research of Murcia, Clinical University Hospital Virgen de la Arrixaca, 30120 Murcia, Spain
4
School of Dentistry, University of Murcia, 30003 Murcia, Spain
5
Unidad de Pacientes Especiales y Gerodontología, Universidad de Murcia, IMIB-Arrixaca, Hospital Morales Meseguer, 30008 Murcia, Spain
*
Author to whom correspondence should be addressed.
Received: 21 July 2018 / Revised: 29 July 2018 / Accepted: 31 July 2018 / Published: 3 August 2018
(This article belongs to the Special Issue Bioactive and Therapeutic Dental Materials)
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Abstract

Background: Cell-Based Therapies (CBT) constitute a valid procedure for increasing the quantity and quality of bone in areas with an inadequate bone volume. However, safety and efficacy should be investigated prior to clinical application. The objective of this study was to evaluate the biodistribution, safety and osteogenic capacity of bone marrow-derived human mesenchymal stem cells (hBMMSCs) pre-seeded into β-tricalcium phosphate (TCP) and implanted into NOD/SCID mice at subcutaneous and intramuscular sites. Methods: hBMMSCs were isolated, characterized and then cultured in vitro on a porous β-TCP scaffold. Cell viability and attachment were analyzed and then hBMMSCs seeded constructs were surgically placed at subcutaneous and intramuscular dorsal sites into NOD/SCID mice. Acute and subchronic toxicity, cell biodistribution and efficacy were investigated. Results: There were no deaths or adverse events in treated mice during the 48-hour observation period, and no toxic response was observed in mice. In the 12-week subchronic toxicity study, no mortalities, abnormal behavioral symptoms or clinical signs were observed in the saline control mice or the hBMMSCs/β-TCP groups. Finally, our results showed the bone-forming capacity of hBMMSCs/β-TCP since immunohistochemical expression of human osteocalcin was detected from week 7. Conclusions: These results show that transplantation of hBMMSCs/β-TCP in NOD/SCID mice are safe and effective, and might be applied to human bone diseases in future clinical trials. View Full-Text
Keywords: preclinical biosafety; bone substitute; mesenchymal stem cells; β-tricalcium phosphate; tissue engineering preclinical biosafety; bone substitute; mesenchymal stem cells; β-tricalcium phosphate; tissue engineering
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Gonzálvez-García, M.; Martinez, C.M.; Villanueva, V.; García-Hernández, A.; Blanquer, M.; Meseguer-Olmo, L.; Oñate Sánchez, R.E.; Moraleda, J.M.; Rodríguez-Lozano, F.J. Preclinical Studies of the Biosafety and Efficacy of Human Bone Marrow Mesenchymal Stem Cells Pre-Seeded into β-TCP Scaffolds after Transplantation. Materials 2018, 11, 1349.

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