First-in-human study and clinical case reports of the alveolar bone regeneration with the secretome from human mesenchym
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RESEARCH
Open Access
First-in-human study and clinical case reports of the alveolar bone regeneration with the secretome from human mesenchymal stem cells Wataru Katagiri*, Masashi Osugi, Takamasa Kawai and Hideharu Hibi
Abstract Background: Secreted growth factors and cytokines in the conditioned medium from bone marrow-derived mesenchymal stem cells (MSC-CM) have several effects on cell behavior. Our previous studies revealed that MSC-CM enhances bone regeneration by increasing cell mobilization, angiogenesis, and osteogenesis in vitro and in vivo. This clinical study was undertaken to evaluate the safety and use of MSC-CM for alveolar bone regeneration in eight patients who were diagnosed as needing bone augmentation prior to dental implant placement. Methods: The protocol of this clinical study was approved by the ethics committee of Nagoya University Hospital. MSC-CM was prepared from conditioned medium from commercially available human bone marrow-derived MSCs. Patients were treated with beta-tricalcuim phosphate (β-TCP) or an atelocollagen sponge soaked with MSC-CM. Clinical and radiographic assessments were performed during the follow-up period. Histological assessments were also performed in some cases. Clinical and histological data from patients who underwent the SFE procedure without MSC-CM were also used retrospectively as reference controls. Results: MSC-CM contained several cytokines such as insulin-like growth factor-1, vascular endothelial growth factor, transforming growth factor-β1, and hepatocyte growth factor in relatively low amounts. No systemic or local complications were reported throughout the study. Radiographic evaluation revealed early bone formation in all cases. Histological evaluation also supported the radiographic findings. Furthermore, infiltration of inflammatory cells was scarce throughout the specimens. Conclusions: MSC-CM was used safely and with less inflammatory signs and appears to have great osteogenic potential for regenerative medicine of bone. This is the first in-human clinical study of alveolar bone regeneration using MSC-CM. Keywords: Secretome, Mesenchymal stem cells (MSC), Tissue engineering, Regenerative medicine, Bone
Background Alveolar bone regeneration with grafting is often carried out prior to placement of dental implants. Several graft materials have been used including autogenous bone, xenogeneic bone, and synthetic bone substitutes. Autogenous bone grafts have been used for a long time with good predictability and are considered the “gold standard” because of their osteoinductive and osteoconductive properties and immunogenic compatibility. However, autogenous * Correspondence: [email protected] Department of Oral and Maxillofacial Surgery, Nagoya University Graduate School of Medicine, 65 Tsuruma-cho, Showa-ku, Nagoya 466-8550, Japan
bone must be harvested from a donor site of the patient and is associated with higher morbidity [1, 2]. Xenogeneic bone and synthetic bone substitutes such as deproteinized bovine bone, hydroxyapatite, and calciu
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