Evidence map›Paper›PMID 40341039›Full record

Trial reportNature communications2025

Acellular, bioresorbable, ultra-purified alginate gel implantation for intervertebral disc herniation: Phase 1/2, open-label, non-randomized clinical trials.

Katsuhisa Yamada, Takahiko Hyakumachi, Terufumi Kokabu, Kenichiro Maeda, Toshiyuki Isoe, Khin Khin Tha, Yoichi M Ito, Takashi Ohnishi, Tsutomu Endo, Daisuke Ukeba and 9 more

Abstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Nature communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Review
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Katsuhisa YamadaDepartment of Orthopaedic Surgery, Hokkaido University Hospital, N14W5, Sapporo, Hokkaido, Japan.ORCID http://orcid.org/0000-0002-9841-5890
Takahiko HyakumachiDepartment of Orthopaedic Surgery, Eniwa Hospital, 2-1-1 Kogane Chuo, Eniwa, Hokkaido, Japan.
Terufumi KokabuDepartment of Orthopaedic Surgery, Eniwa Hospital, 2-1-1 Kogane Chuo, Eniwa, Hokkaido, Japan.
Kenichiro MaedaClinical Research and Medical Innovation Center, Institute of Health Science Innovation for Medical Care, Hokkaido University Hospital, N14W5, Sapporo, Hokkaido, Japan.
Toshiyuki IsoeClinical Research and Medical Innovation Center, Institute of Health Science Innovation for Medical Care, Hokkaido University Hospital, N14W5, Sapporo, Hokkaido, Japan.
Khin Khin ThaGlobal Center for Biomedical Science and Engineering, Hokkaido University Faculty of Medicine, N15W7, Sapporo, Hokkaido, Japan.ORCID http://orcid.org/0000-0002-9072-4509
Yoichi M ItoData Science Center, Institute of Health Science Innovation for Medical Care, Hokkaido University Hospital, N14W5, Sapporo, Hokkaido, Japan.
Takashi OhnishiDepartment of Orthopaedic Surgery, Hokkaido University Hospital, N14W5, Sapporo, Hokkaido, Japan.ORCID http://orcid.org/0000-0002-9228-7250
Tsutomu EndoDepartment of Orthopaedic Surgery, Hokkaido University Hospital, N14W5, Sapporo, Hokkaido, Japan.
Daisuke UkebaDepartment of Orthopaedic Surgery, Hokkaido University Hospital, N14W5, Sapporo, Hokkaido, Japan.ORCID http://orcid.org/0000-0002-8844-3476
Hiroyuki TachiDepartment of Orthopaedic Surgery, Hokkaido University Hospital, N14W5, Sapporo, Hokkaido, Japan.
Yuichiro AbeDepartment of Orthopaedic Surgery, Eniwa Hospital, 2-1-1 Kogane Chuo, Eniwa, Hokkaido, Japan.
Yoko IshikawaDepartment of Orthopaedic Surgery, Eniwa Hospital, 2-1-1 Kogane Chuo, Eniwa, Hokkaido, Japan.
Nozomi YokotaClinical Research and Medical Innovation Center, Institute of Health Science Innovation for Medical Care, Hokkaido University Hospital, N14W5, Sapporo, Hokkaido, Japan.
Takashi MiyakoshiClinical Research and Medical Innovation Center, Institute of Health Science Innovation for Medical Care, Hokkaido University Hospital, N14W5, Sapporo, Hokkaido, Japan.ORCID http://orcid.org/0000-0002-7952-862X
Osamu SugitaClinical Research and Medical Innovation Center, Institute of Health Science Innovation for Medical Care, Hokkaido University Hospital, N14W5, Sapporo, Hokkaido, Japan.
Norihiro SatoClinical Research and Medical Innovation Center, Institute of Health Science Innovation for Medical Care, Hokkaido University Hospital, N14W5, Sapporo, Hokkaido, Japan.
Norimasa IwasakiDepartment of Orthopaedic Surgery, Hokkaido University Hospital, N14W5, Sapporo, Hokkaido, Japan.
Hideki SudoDepartment of Orthopaedic Surgery, Hokkaido University Hospital, N14W5, Sapporo, Hokkaido, Japan. hidekisudo@yahoo.co.jp.ORCID http://orcid.org/0000-0002-8635-4648

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Discectomy is the current surgical procedure for lumbar intervertebral disc (IVD) herniation. Discectomy was performed to remove the IVD material and relieve the pain inflicted by nerve root compression and axonotoxic effects, such as inflammatory cytokines in the IVD material; however, defects within the IVD caused by discectomy may impair tissue healing and predispose patients to subsequent IVD degeneration. Given that viable cells with the capacity for IVD regeneration are scarce, discectomy alone is not conducive to tissue repair. Here, we report the use of an acellular, bioresorbable, ultra-purified alginate (UPAL) gel implantation system to prevent IVD degeneration after discectomy and demonstrate its feasibility and safety in phase 1/2, open-label, non-randomized clinical trials conducted at a double center. This study comprised two parts: a prospective study on UPAL gel implantation after discectomy in patients with lumbar disc herniation, and a subsequent prospective study on patients who underwent discectomy without UPAL implantation as a control group. The control group was recruited separately. The primary outcomes of this study were the feasibility and safety of UPAL implantation, and the secondary outcomes included physical function scores, self-report questionnaires (SRQs) evaluating pain and health-related quality of life and magnetic resonance imaging (MRI)-based measures of IVD tissues. The UPAL gel implantation demonstrated 100% feasibility and safety (n = 40). The physical function scores improved significantly postoperatively in both groups, with the UPAL group demonstrating greater improvements over time compared to the control group. The SRQ scores were significantly higher in the UPAL group than in the control group from the early postoperative period to 12 weeks. MRI revealed that the disc degeneration score was significantly lower in IVDs with UPAL implantation than in those that underwent discectomy alone. The findings of this study suggest that the UPAL gel is a novel therapeutic strategy after discectomy in cases of lumbar IVD herniation. Trial number: UMIN000034227, UMIN000042282.

Indexed as

Absorbable ImplantsAlginatesIntervertebral Disc DisplacementAdultDiskectomyFemaleGelsHumansIntervertebral Disc DegenerationLumbar VertebraeMaleMiddle AgedProspective StudiesTreatment OutcomeAlginatesGels

Identifiers

PMID40341039
PMCPMC12062309

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.