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. 2016:2016:6205910.
doi: 10.1155/2016/6205910. Epub 2016 Nov 20.

Phase I/II Trial of Autologous Bone Marrow Stem Cell Transplantation with a Three-Dimensional Woven-Fabric Scaffold for Periodontitis

Shunsuke Baba  1 , Yoichi Yamada  2 , Akira Komuro  1 , Yoritaka Yotsui  3 , Makoto Umeda  4 , Kimishige Shimuzutani  3 , Sayaka Nakamura  5
Affiliations

Phase I/II Trial of Autologous Bone Marrow Stem Cell Transplantation with a Three-Dimensional Woven-Fabric Scaffold for Periodontitis

Shunsuke Baba et al. Stem Cells Int. 2016.

Abstract

Regenerative medicine is emerging as a promising option, but the potential of autologous stem cells has not been investigated well in clinical settings of periodontal treatment. In this clinical study, we evaluated the safety and efficacy of a new regenerative therapy based on the surgical implantation of autologous mesenchymal stem cells (MSCs) with a biodegradable three-dimensional (3D) woven-fabric composite scaffold and platelet-rich plasma (PRP). Ten patients with periodontitis, who required a surgical procedure for intrabony defects, were enrolled in phase I/II trial. Once MSCs were implanted in each periodontal intrabony defect, the patients were monitored during 36 months for a medical exam including laboratory tests of blood and urine samples, changes in clinical attachment level, pocket depth, and linear bone growth (LBG). All three parameters improved significantly during the entire follow-up period (p < 0.0001), leading to an average LBG of 4.7 mm after 36 months. Clinical mobility measured by Periotest showed a decreasing trend after the surgery. No clinical safety problems attributable to the investigational MSCs were identified. This clinical trial suggests that the stem cell therapy using MSCs-PRP/3D woven-fabric composite scaffold may constitute a novel safe and effective regenerative treatment option for periodontitis.

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Conflict of interest statement

The authors declare that there is no conflict of interests regarding the publication of this paper.

Figures

Figure 1
Figure 1
Treatment schedule.
Figure 2
Figure 2
(a) Positive alkaline phosphatase staining of osteoinduced BMMSCs. (b) BMMSCs proliferate on the basket-shaped scaffold. (c) The combination of BMMSCs/PRP and thrombin in calcium chloride generates a gel-like structure. (d) Representative image of the periodontal intrabony defect (preoperative). (e, f) X-ray images taken before and 8 weeks after the surgery.
Figure 3
Figure 3
Mean change in the depth of the intrabony defect after operation. Linear bone growth (LBG) significantly increased during the follow-up period. ∗ p < 0.01.
See this image and copyright information in PMC

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