Evidence map›Paper›PMID 36555944›Full record

ArticleJournal of clinical medicine2022

A Clinical Study of Alveolar Bone Tissue Engineering Using Autologous Bone Marrow Stromal Cells: Effect of Optimized Cell-Processing Protocol on Efficacy.

Hideaki Kagami, Minoru Inoue, Hideki Agata, Izumi Asahina, Tokiko Nagamura-Inoue, Masataka Taguri, Arinobu Tojo

Abstract read
In one paragraph

Article in Journal of clinical medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Bone Regeneration: Overview and Future Trends.Journal of clinical medicine · 2023
    Article
  2. Article
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

7 authors.

Hideaki KagamiDivision of Stem Cell Engineering, The Institute of Medical Science, The University of Tokyo, Tokyo 108-8639, Japan.ORCID 0000-0003-2285-2602
Minoru InoueTissue Engineering Research Group, Division of Molecular Therapy, The Advanced Clinical Research Center, The Institute of Medical Science, The University of Tokyo, Tokyo 108-8639, Japan.
Hideki AgataDivision of Stem Cell Engineering, The Institute of Medical Science, The University of Tokyo, Tokyo 108-8639, Japan.
Izumi AsahinaDivision of Stem Cell Engineering, The Institute of Medical Science, The University of Tokyo, Tokyo 108-8639, Japan.ORCID 0000-0001-9448-2001
Tokiko Nagamura-InoueDepartment of Cell Processing and Transfusion, The Institute of Medical Science, Research Hospital, The University of Tokyo, Tokyo 108-8639, Japan.
Masataka TaguriDivision of Medical Data Science, Tokyo Medical University, Tokyo 160-8402, Japan.
Arinobu TojoTissue Engineering Research Group, Division of Molecular Therapy, The Advanced Clinical Research Center, The Institute of Medical Science, The University of Tokyo, Tokyo 108-8639, Japan.

Funding

Ministry of Education, Culture, Sports, Science and Technology (MEXT) of Japan 920724The Ministry of Health, Labour, and Welfare of Japan, H23-Regeneration-002
6 · The paper itself

Abstract

(1) Objectives: The effect of cell-processing protocols on the clinical efficacy of bone tissue engineering is not well-known. To maximize efficacy, we optimized the cell-processing protocol for bone-marrow-derived mesenchymal stromal cells for bone tissue engineering. In this study, the efficacy of bone tissue engineering using this modified protocol was compared to that of the original protocol. (2) Materials and Methods: This single-arm clinical study included 15 patients. Cells were obtained from bone marrow aspirates and expanded in culture flasks containing basic fibroblast growth factor. The cells were seeded onto β-tricalcium phosphate granules and induced into osteogenic cells for two weeks. Then, the cell-scaffold composites were transplanted into patients with severe atrophic alveolar bone. Radiographic evaluations and bone biopsies were performed. The results were compared with those of a previous clinical study that used the original protocol. (3) Results: Panoramic X-ray and computed tomography showed bone regeneration at the transplantation site in all cases. The average bone area in the biopsy samples at 4 months was 44.0%, which was comparable to that in a previous clinical study at 6 months (41.9%) but with much less deviation. No side effects related to cell transplantation were observed. In regenerated bone, 100% of the implants were integrated. (4) Conclusions: Compared to the original protocol, the non-inferiority of this protocol was proven. The introduction of an optimized cell-processing protocol resulted in a comparable quality of regenerated bone, with less fluctuation. Optimized cell-processing protocols may contribute to stable bone regeneration.

Indexed as

atrophic alveolar bonebone marrowbone tissue engineeringclinical studymesenchymal stem cellsmesenchymal stromal cells

Identifiers

PMID36555944
PMCPMC9783548

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Registered trials

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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.