title: Phase I/II Trial of Autologous Bone Marrow Stem Cell Transplantation with a Three-Dimensional Woven-Fabric Scaffold for Periodontitis.
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.
authors.affiliation: Department of Oral Implantology, Osaka Dental University, 1-5-17 Otemae Chuo-ku, Osaka 540-0008, Japan.
authors.forename: Shunsuke
authors.initials: S
authors.lastname: Baba
authors.affiliation: Department of Oral Implantology, Osaka Dental University, 1-5-17 Otemae Chuo-ku, Osaka 540-0008, Japan; Department of Oral and Maxillofacial Surgery, Aichi Medical University School of Medicine, 1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan.
authors.forename: Yoichi
authors.identifier: 0000-0002-7604-2755
authors.initials: Y
authors.lastname: Yamada
authors.affiliation: Department of Oral Implantology, Osaka Dental University, 1-5-17 Otemae Chuo-ku, Osaka 540-0008, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Komuro
authors.affiliation: Department of Oral Radiology, Osaka Dental University, 1-5-17 Otemae Chuo-ku, Osaka 540-0008, Japan.
authors.forename: Yoritaka
authors.initials: Y
authors.lastname: Yotsui
authors.affiliation: Department of Periodontology, Osaka Dental University, 8-1 Kuzuhahanazono-cho Hirakata, Osaka 573-1121, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Umeda
authors.affiliation: Department of Oral Radiology, Osaka Dental University, 1-5-17 Otemae Chuo-ku, Osaka 540-0008, Japan.
authors.forename: Kimishige
authors.initials: K
authors.lastname: Shimuzutani
authors.affiliation: Department of Oral and Maxillofacial Surgery, Aichi Medical University School of Medicine, 1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan; Department of Biochemistry, School of Dentistry, Aichi Gakuin University, 1-100 Kusumoto-cyo, Chikusa-ku, Nagoya 464-8650, Japan.
authors.forename: Sayaka
authors.initials: S
authors.lastname: Nakamura