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Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation : Study protocol for a first-in-human pilot study

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Title: Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation : Study protocol for a first-in-human pilot study
Authors: Yamada, Katsuhisa Browse this author
Kenichiro, Maeda Browse this author
Ito, Yoichi M. Browse this author
Inage, Fujio Browse this author
Isoe, Toshiyuki Browse this author
Yokota, Nozomi Browse this author
Sugita, Osamu Browse this author
Sato, Norihiro Browse this author
Tha, Khin Khin Browse this author
Iwasaki, Norimasa Browse this author
Arato, Teruyo Browse this author
Sudo, Hideki Browse this author →KAKEN DB
Keywords: Intervertebral disc herniation
Ultra-purified alginate gel
First-in-human pilot study
Issue Date: Sep-2021
Publisher: Elsevier
Journal Title: Contemporary clinical trials communications
Volume: 23
Start Page: 100805
Publisher DOI: 10.1016/j.conctc.2021.100805
Abstract: Herniated nucleus pulposus (NP), one of the most common diseases of the spine, is surgically treated by removing the sequestered NP. However, intervertebral disc (IVD) defects may remain after discectomy, leading to inadequate tissue healing and predisposing patients to IVD degeneration. An acellular, bioresorbable, ultrapurified alginate (UPAL) gel (dMD-001) implantation system can be used to fill any IVD defects in order to prevent IVD degeneration after discectomy. This first-in-human pilot study aims to determine the feasibility, safety, and perceived patient response to a combined treatment involving discectomy and UPAL gel implantation for herniated NP. We designed a one-arm, double-centre, open-label, pilot trial. The study started in November 2018 and will run until a sample of 40 suitable participants is established. Patients aged 20-49 years, diagnosed with isolated lumbar IVD herniation and scheduled for discectomy represent suitable candidates. All eligible participants who provide informed consent undergo standard discectomy followed by UPAL gel implantation. The primary outcomes of the trial will be the feasibility and safety of the procedure. Secondary outcomes will include self-assessed clinical scores and magnetic resonance imaging-based measures of morphological and compositional quality of the IVD tissue. Initial outcomes will be published at 24 weeks. Analysis of feasibility and safety will be performed using descriptive statistics. Both intention-to-treat and per-protocol analyses of treatment trends of effectiveness will be conducted.
Type: article
Appears in Collections:医学院・医学研究院 (Graduate School of Medicine / Faculty of Medicine) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

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