Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation: Study protocol for a first-in-human pilot study
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 acellula...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2021-09-01
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| Series: | Contemporary Clinical Trials Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S245186542100106X |
| _version_ | 1819135027027378176 |
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| author | Katsuhisa Yamada Maeda Kenichiro Yoichi M. Ito Fujio Inage Toshiyuki Isoe Nozomi Yokota Osamu Sugita Norihiro Sato Khin Khin Tha Norimasa Iwasaki Teruyo Arato Hideki Sudo |
| author_facet | Katsuhisa Yamada Maeda Kenichiro Yoichi M. Ito Fujio Inage Toshiyuki Isoe Nozomi Yokota Osamu Sugita Norihiro Sato Khin Khin Tha Norimasa Iwasaki Teruyo Arato Hideki Sudo |
| author_sort | Katsuhisa Yamada |
| collection | DOAJ |
| description | 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, ultra-purified 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. |
| first_indexed | 2024-12-22T10:12:33Z |
| format | Article |
| id | doaj.art-18fb999ea9634c8d9e95714d6cc04acc |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-12-22T10:12:33Z |
| publishDate | 2021-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-18fb999ea9634c8d9e95714d6cc04acc2022-12-21T18:29:48ZengElsevierContemporary Clinical Trials Communications2451-86542021-09-0123100805Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation: Study protocol for a first-in-human pilot studyKatsuhisa Yamada0Maeda Kenichiro1Yoichi M. Ito2Fujio Inage3Toshiyuki Isoe4Nozomi Yokota5Osamu Sugita6Norihiro Sato7Khin Khin Tha8Norimasa Iwasaki9Teruyo Arato10Hideki Sudo11Department of Orthopaedic Surgery, Hokkaido University Hospital, N14W5, Sapporo, Japan; Department of Orthopaedic Surgery, Faculty of Medicine, and Graduate School of Medicine, Hokkaido University, N15W7, Sapporo, Hokkaido, 060-8638, JapanClinical Research and Medical Innovation Center, Hokkaido University Hospital, N14W5, Sapporo, JapanDepartment of Biostatistics, Hokkaido University Graduate School of Medicine, N14W5, Sapporo, Hokkaido, JapanClinical Research and Medical Innovation Center, Hokkaido University Hospital, N14W5, Sapporo, JapanClinical Research and Medical Innovation Center, Hokkaido University Hospital, N14W5, Sapporo, JapanClinical Research and Medical Innovation Center, Hokkaido University Hospital, N14W5, Sapporo, JapanClinical Research and Medical Innovation Center, Hokkaido University Hospital, N14W5, Sapporo, JapanClinical Research and Medical Innovation Center, Hokkaido University Hospital, N14W5, Sapporo, JapanDepartment of Diagnostic Imaging, Hokkaido University Hospital, N14W5, Sapporo, Hokkaido, JapanDepartment of Orthopaedic Surgery, Hokkaido University Hospital, N14W5, Sapporo, Japan; Department of Orthopaedic Surgery, Faculty of Medicine, and Graduate School of Medicine, Hokkaido University, N15W7, Sapporo, Hokkaido, 060-8638, JapanClinical Research and Medical Innovation Center, Hokkaido University Hospital, N14W5, Sapporo, JapanDepartment of Orthopaedic Surgery, Hokkaido University Hospital, N14W5, Sapporo, Japan; Department of Advanced Medicine for Spine and Spinal Cord Disorders, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Japan; Corresponding author. Department of Advanced Medicine for Spine and Spinal Cord Disorders, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, N15W7, Sapporo, Hokkaido, 060-8638, Japan.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, ultra-purified 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.http://www.sciencedirect.com/science/article/pii/S245186542100106XIntervertebral disc herniationUltra-purified alginate gelFirst-in-human pilot study |
| spellingShingle | Katsuhisa Yamada Maeda Kenichiro Yoichi M. Ito Fujio Inage Toshiyuki Isoe Nozomi Yokota Osamu Sugita Norihiro Sato Khin Khin Tha Norimasa Iwasaki Teruyo Arato Hideki Sudo Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation: Study protocol for a first-in-human pilot study Contemporary Clinical Trials Communications Intervertebral disc herniation Ultra-purified alginate gel First-in-human pilot study |
| 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 |
| title_full | Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation: Study protocol for a first-in-human pilot study |
| title_fullStr | Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation: Study protocol for a first-in-human pilot study |
| title_full_unstemmed | Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation: Study protocol for a first-in-human pilot study |
| title_short | Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation: Study protocol for a first-in-human pilot study |
| title_sort | exploratory clinical trial on the safety and capability of dmd 001 in lumbar disc herniation study protocol for a first in human pilot study |
| topic | Intervertebral disc herniation Ultra-purified alginate gel First-in-human pilot study |
| url | http://www.sciencedirect.com/science/article/pii/S245186542100106X |
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