Phase I/II Trial of Autologous Bone Marrow Stem Cell Transplantation with a Three-Dimensional Woven-Fabric Scaffold for Periodontitis
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 implantat...
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| Format: | Article |
| Language: | English |
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Wiley
2016-01-01
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| Series: | Stem Cells International |
| Online Access: | http://dx.doi.org/10.1155/2016/6205910 |
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| author | Shunsuke Baba Yoichi Yamada Akira Komuro Yoritaka Yotsui Makoto Umeda Kimishige Shimuzutani Sayaka Nakamura |
| author_facet | Shunsuke Baba Yoichi Yamada Akira Komuro Yoritaka Yotsui Makoto Umeda Kimishige Shimuzutani Sayaka Nakamura |
| author_sort | Shunsuke Baba |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-ad2f792d11d541bab4f26bb490338491 |
| institution | Kabale University |
| issn | 1687-966X 1687-9678 |
| language | English |
| publishDate | 2016-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Stem Cells International |
| spelling | doaj-art-ad2f792d11d541bab4f26bb4903384912025-08-20T03:38:55ZengWileyStem Cells International1687-966X1687-96782016-01-01201610.1155/2016/62059106205910Phase I/II Trial of Autologous Bone Marrow Stem Cell Transplantation with a Three-Dimensional Woven-Fabric Scaffold for PeriodontitisShunsuke Baba0Yoichi Yamada1Akira Komuro2Yoritaka Yotsui3Makoto Umeda4Kimishige Shimuzutani5Sayaka Nakamura6Department of Oral Implantology, Osaka Dental University, 1-5-17 Otemae Chuo-ku, Osaka 540-0008, JapanDepartment of Oral Implantology, Osaka Dental University, 1-5-17 Otemae Chuo-ku, Osaka 540-0008, JapanDepartment of Oral Implantology, Osaka Dental University, 1-5-17 Otemae Chuo-ku, Osaka 540-0008, JapanDepartment of Oral Radiology, Osaka Dental University, 1-5-17 Otemae Chuo-ku, Osaka 540-0008, JapanDepartment of Periodontology, Osaka Dental University, 8-1 Kuzuhahanazono-cho Hirakata, Osaka 573-1121, JapanDepartment of Oral Radiology, Osaka Dental University, 1-5-17 Otemae Chuo-ku, Osaka 540-0008, JapanDepartment of Oral and Maxillofacial Surgery, Aichi Medical University School of Medicine, 1-1 Yazakokarimata, Nagakute, Aichi 480-1195, JapanRegenerative 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.http://dx.doi.org/10.1155/2016/6205910 |
| spellingShingle | Shunsuke Baba Yoichi Yamada Akira Komuro Yoritaka Yotsui Makoto Umeda Kimishige Shimuzutani Sayaka Nakamura Phase I/II Trial of Autologous Bone Marrow Stem Cell Transplantation with a Three-Dimensional Woven-Fabric Scaffold for Periodontitis Stem Cells International |
| title | Phase I/II Trial of Autologous Bone Marrow Stem Cell Transplantation with a Three-Dimensional Woven-Fabric Scaffold for Periodontitis |
| title_full | Phase I/II Trial of Autologous Bone Marrow Stem Cell Transplantation with a Three-Dimensional Woven-Fabric Scaffold for Periodontitis |
| title_fullStr | Phase I/II Trial of Autologous Bone Marrow Stem Cell Transplantation with a Three-Dimensional Woven-Fabric Scaffold for Periodontitis |
| title_full_unstemmed | Phase I/II Trial of Autologous Bone Marrow Stem Cell Transplantation with a Three-Dimensional Woven-Fabric Scaffold for Periodontitis |
| title_short | Phase I/II Trial of Autologous Bone Marrow Stem Cell Transplantation with a Three-Dimensional Woven-Fabric Scaffold for Periodontitis |
| title_sort | phase i ii trial of autologous bone marrow stem cell transplantation with a three dimensional woven fabric scaffold for periodontitis |
| url | http://dx.doi.org/10.1155/2016/6205910 |
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