| アイテムタイプ |
学術雑誌論文 / Journal Article(1) |
| 公開日 |
2026-01-29 |
| タイトル |
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タイトル |
First-in-human study to investigate the safety and efficacy of effective-mononuclear cell therapy for radiogenic xerostomia |
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言語 |
en |
| 言語 |
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|
言語 |
eng |
| 資源タイプ |
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資源タイプ識別子 |
http://purl.org/coar/resource_type/c_6501 |
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資源タイプ |
journal article |
| 著者 |
I, Takashi
Iwatake, Mayumi
Yoshida, Takako
Nagai, Kazuhiro
Hotokezaka, Yuka
Nishihara, Mika
Honma, Ryo
Harada, Hiroshi
Hayashida, Munehiro
Nagano, Toshiki
Kanai, Riho
Ohba, Seigo
Yoshimura, Atsutoshi
Masuda, Haruchika
Asahara, Takayuki
Miyazaki, Yasushi
Kawakami, Atsushi
Asahina, Izumi
Seki, Makoto
Sumita, Yoshinori
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| 抄録 |
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内容記述タイプ |
Abstract |
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内容記述 |
Background: Salivary gland (SG) hypofunction is the most common complication following radiotherapy for head and neck cancer. Currently, there are no effective therapies for radiation-induced xerostomia. We recently developed a novel therapy for preclinical studies using effective-mononuclear cells (E-MNCs) induced from autologous peripheral blood mononuclear cells (PB-MNCs) via a new primary culture system for treatment of radiation-induced xerostomia. However, the safety and effectiveness of E-MNC therapy have not been assessed in humans. The objective of this first-in-human study was to evaluate the safety, tolerability, and in part the efficacy of E-MNC therapy for treating radiation-induced xerostomia. Methods: This first-in-human study was an open-label, single-center, two-step dose escalation study. A total of 5 patients who had no recurrence of head and neck cancer over a 5-year period following radiation therapy and suffered from radiation-induced xerostomia received a transplantation of E-MNCs to one-sided submandibular gland (SMG). The primary endpoint was the safety of the protocol. The secondary endpoint was effectiveness evaluated based on change from baseline in whole-saliva secretion, MRI/CT-evaluated volume of the SMG and subjective/objective symptoms after intervention. The duration of the intervention was 1 year. Results: During follow-up, no treatment-related adverse events were detected. The stimulated whole salivary flow rate increased from an average of 3.86 mL/10 min at baseline to 5.16 mL/10 min at 6 months post–investigational intervention. Additionally, subjective/objective symptoms improved in 4 of 5 treated patients. By contrast, imaging findings revealed no obvious changes in MRI/CT-evaluated volume of SMGs due to conspicuous progression of atrophy and fibrosis compared with baseline. Conclusion: This is the first clinical study to evaluate the safety and efficacy of E-MNC treatment in patients with severe radiation-induced xerostomia. The results of our study indicate that E-MNC treatment is safe and effective, and provide valuable information that will aid in designing subsequent clinical studies. |
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言語 |
en |
| 書誌情報 |
en : Regenerative Therapy
巻 31,
p. art. no. 101059,
発行日 2026-01-10
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| 出版者 |
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出版者 |
Elsevier B.V. |
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言語 |
en |
| ISSN |
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収録物識別子タイプ |
ISSN |
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収録物識別子 |
23523204 |
| DOI |
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関連タイプ |
isIdenticalTo |
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識別子タイプ |
DOI |
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関連識別子 |
https://doi.org/10.1016/j.reth.2025.101059 |
| 権利 |
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権利情報 |
© 2025 The Author(s). Published by Elsevier BV on behalf of The Japanese Society for Regenerative Medicine. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
|
言語 |
en |
| 著者版フラグ |
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出版タイプ |
VoR |
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出版タイプResource |
http://purl.org/coar/version/c_970fb48d4fbd8a85 |
| 引用 |
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内容記述タイプ |
Other |
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内容記述 |
Regenerative Therapy, 31, art. no. 101059; 2026 |
|
言語 |
en |
RT31_101059.pdf (2.6 MB)
