Study protocol for periodontal tissue regeneration with a mixture of autologous adipose-derived stem cells and platelet rich plasma: A multicenter, randomized, open-label clinical trial
Introduction: Adipose-derived stem cells (ASCs) secrete various growth factors to promote wound healing and to regenerate various tissues, such as bone, cartilage, and fat tissue. Subcutaneous adipose tissue is a considerable cell source in clinical practice and can be collected relatively easily an...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2022-12-01
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| Series: | Regenerative Therapy |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2352320422000943 |
| _version_ | 1811178689787854848 |
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| author | Morikuni Tobita Yosuke Masubuchi Yorimasa Ogata Akio Mitani Takeshi Kikuchi Taku Toriumi Jorge Luis Montenegro Raudales Hiroshi Mizuno Yuki Suzuki Keiko Wakana Hikari Yoneda Reika Kamijo Masahiro Kino-oka Tomohiro Morio Kiyoshi Okada Shinya Murakami Masaki Honda |
| author_facet | Morikuni Tobita Yosuke Masubuchi Yorimasa Ogata Akio Mitani Takeshi Kikuchi Taku Toriumi Jorge Luis Montenegro Raudales Hiroshi Mizuno Yuki Suzuki Keiko Wakana Hikari Yoneda Reika Kamijo Masahiro Kino-oka Tomohiro Morio Kiyoshi Okada Shinya Murakami Masaki Honda |
| author_sort | Morikuni Tobita |
| collection | DOAJ |
| description | Introduction: Adipose-derived stem cells (ASCs) secrete various growth factors to promote wound healing and to regenerate various tissues, such as bone, cartilage, and fat tissue. Subcutaneous adipose tissue is a considerable cell source in clinical practice and can be collected relatively easily and safely under local anesthesia. Moreover, platelet-rich plasma (PRP), a plasma component containing many platelets purified by centrifuging the collected blood, also promotes wound healing. PRP can be easily gelled and is therefore attracting attention as a scaffolding material for transplanted cells. The usefulness of a mixture of ASCs and PRP for periodontal tissue regeneration has been in vitro demonstrated in our previous study. The aim of this study is to present the protocol of translation of tissue regeneration with ASCs and PRP into practical use, evaluating its efficacy. Methods: This study is a multicenter, randomized, open-label comparative clinical trial. Fifteen patients will be randomly assigned to the treatment with mixture of ASCs and PRP or enamel matrix derivate administration into periodontal tissue defects. Increase in height of new alveolar bone in the transplanted area will be evaluated. The evaluation will be performed using dental radiographs after 36 weeks of transplantation. Occurrence of adverse events will be evaluated as secondary outcome. Results: This clinical study was initiated after meeting the regulations to be complied with, including ethical review and regulatory notifications. Conclusions: If effective, this cell therapy using autologous mesenchymal stem cells can represent a useful medical technology for regeneration of periodontal defects. |
| first_indexed | 2024-04-11T06:23:40Z |
| format | Article |
| id | doaj.art-150826d1d17842c998f70fefcf8d61fb |
| institution | Directory Open Access Journal |
| issn | 2352-3204 |
| language | English |
| last_indexed | 2024-04-11T06:23:40Z |
| publishDate | 2022-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Regenerative Therapy |
| spelling | doaj.art-150826d1d17842c998f70fefcf8d61fb2022-12-22T04:40:28ZengElsevierRegenerative Therapy2352-32042022-12-0121436441Study protocol for periodontal tissue regeneration with a mixture of autologous adipose-derived stem cells and platelet rich plasma: A multicenter, randomized, open-label clinical trialMorikuni Tobita0Yosuke Masubuchi1Yorimasa Ogata2Akio Mitani3Takeshi Kikuchi4Taku Toriumi5Jorge Luis Montenegro Raudales6Hiroshi Mizuno7Yuki Suzuki8Keiko Wakana9Hikari Yoneda10Reika Kamijo11Masahiro Kino-oka12Tomohiro Morio13Kiyoshi Okada14Shinya Murakami15Masaki Honda16Department of Oral and Maxillofacial Surgery, Juntendo University Hospital, 3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan; Medical Technology Innovation Center, Juntendo University, 2-1-1 Hongo, Bunkyo, Tokyo 1138421, Japan; Department of Plastic and Reconstructive Surgery, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo, Tokyo 1138421, Japan; Clinical Trial and Research Center, Juntendo University Hospital, 3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan; Corresponding author. Medical Technology Innovation Center, Juntendo University, 2-1-1 Hongo, Bunkyo, Tokyo 1138421, Japan. Fax: +81 3 5802 1715.Medical Technology Innovation Center, Juntendo University, 2-1-1 Hongo, Bunkyo, Tokyo 1138421, JapanDepartment of Periodontology, Nihon University School of Dentistry at Matsudo, 2-870-1 Sakae-cho Nishi, Matsudo, Chiba 271-8587, JapanDepartment of Periodontology, School of Dentistry, Aichi Gakuin University, 2-11 Suemoridori, Chikusa-ku, Nagoya, Aichi 464-8651, JapanDepartment of Periodontology, School of Dentistry, Aichi Gakuin University, 2-11 Suemoridori, Chikusa-ku, Nagoya, Aichi 464-8651, JapanDepartment of Oral Anatomy, School of Dentistry, Aichi Gakuin University, 1-100 Kusumotocho, Chikusa-ku, Nagoya, Aichi 464-8650, Japan; Faculty of Rehabilitation, Kyushu Nutrition Welfare University, 1-5-1 Kuzuharatakamatsu, Kokuraminami-ku, Kitakyushu, Fukuoka 800-0298, JapanDepartment of Oral Anatomy, School of Dentistry, Aichi Gakuin University, 1-100 Kusumotocho, Chikusa-ku, Nagoya, Aichi 464-8650, JapanDepartment of Plastic and Reconstructive Surgery, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo, Tokyo 1138421, JapanDepartment of Periodontology, School of Dentistry, Aichi Gakuin University, 2-11 Suemoridori, Chikusa-ku, Nagoya, Aichi 464-8651, JapanMedical Technology Innovation Center, Juntendo University, 2-1-1 Hongo, Bunkyo, Tokyo 1138421, JapanClinical Trial and Research Center, Juntendo University Hospital, 3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, JapanMedical Technology Innovation Center, Juntendo University, 2-1-1 Hongo, Bunkyo, Tokyo 1138421, JapanDepartment of Biotechnology, Graduate School of Engineering, Osaka University, 2-1 Yamadaoka, Suita, Osaka 565-0871, JapanDepartment of Pediatrics and Developmental Biology, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, JapanDepartment of Orthopaedic Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, JapanDepartment of Periodontology, Osaka University Graduate School of Dentistry, 1-8, Yamadaoka, Suita, Osaka 565-0871, JapanDepartment of Oral Anatomy, School of Dentistry, Aichi Gakuin University, 1-100 Kusumotocho, Chikusa-ku, Nagoya, Aichi 464-8650, JapanIntroduction: Adipose-derived stem cells (ASCs) secrete various growth factors to promote wound healing and to regenerate various tissues, such as bone, cartilage, and fat tissue. Subcutaneous adipose tissue is a considerable cell source in clinical practice and can be collected relatively easily and safely under local anesthesia. Moreover, platelet-rich plasma (PRP), a plasma component containing many platelets purified by centrifuging the collected blood, also promotes wound healing. PRP can be easily gelled and is therefore attracting attention as a scaffolding material for transplanted cells. The usefulness of a mixture of ASCs and PRP for periodontal tissue regeneration has been in vitro demonstrated in our previous study. The aim of this study is to present the protocol of translation of tissue regeneration with ASCs and PRP into practical use, evaluating its efficacy. Methods: This study is a multicenter, randomized, open-label comparative clinical trial. Fifteen patients will be randomly assigned to the treatment with mixture of ASCs and PRP or enamel matrix derivate administration into periodontal tissue defects. Increase in height of new alveolar bone in the transplanted area will be evaluated. The evaluation will be performed using dental radiographs after 36 weeks of transplantation. Occurrence of adverse events will be evaluated as secondary outcome. Results: This clinical study was initiated after meeting the regulations to be complied with, including ethical review and regulatory notifications. Conclusions: If effective, this cell therapy using autologous mesenchymal stem cells can represent a useful medical technology for regeneration of periodontal defects.http://www.sciencedirect.com/science/article/pii/S2352320422000943Clinical studyPeriodontal diseaseTissue engineeringAdipose-derived stem cellsPlatelet-rich plasmaPeriodontal tissue regeneration |
| spellingShingle | Morikuni Tobita Yosuke Masubuchi Yorimasa Ogata Akio Mitani Takeshi Kikuchi Taku Toriumi Jorge Luis Montenegro Raudales Hiroshi Mizuno Yuki Suzuki Keiko Wakana Hikari Yoneda Reika Kamijo Masahiro Kino-oka Tomohiro Morio Kiyoshi Okada Shinya Murakami Masaki Honda Study protocol for periodontal tissue regeneration with a mixture of autologous adipose-derived stem cells and platelet rich plasma: A multicenter, randomized, open-label clinical trial Regenerative Therapy Clinical study Periodontal disease Tissue engineering Adipose-derived stem cells Platelet-rich plasma Periodontal tissue regeneration |
| title | Study protocol for periodontal tissue regeneration with a mixture of autologous adipose-derived stem cells and platelet rich plasma: A multicenter, randomized, open-label clinical trial |
| title_full | Study protocol for periodontal tissue regeneration with a mixture of autologous adipose-derived stem cells and platelet rich plasma: A multicenter, randomized, open-label clinical trial |
| title_fullStr | Study protocol for periodontal tissue regeneration with a mixture of autologous adipose-derived stem cells and platelet rich plasma: A multicenter, randomized, open-label clinical trial |
| title_full_unstemmed | Study protocol for periodontal tissue regeneration with a mixture of autologous adipose-derived stem cells and platelet rich plasma: A multicenter, randomized, open-label clinical trial |
| title_short | Study protocol for periodontal tissue regeneration with a mixture of autologous adipose-derived stem cells and platelet rich plasma: A multicenter, randomized, open-label clinical trial |
| title_sort | study protocol for periodontal tissue regeneration with a mixture of autologous adipose derived stem cells and platelet rich plasma a multicenter randomized open label clinical trial |
| topic | Clinical study Periodontal disease Tissue engineering Adipose-derived stem cells Platelet-rich plasma Periodontal tissue regeneration |
| url | http://www.sciencedirect.com/science/article/pii/S2352320422000943 |
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