Evidence map›Paper›PMID 37798633›Full record

Trial reportBMC medicine2023

Phase III clinical trial of autologous CD34 + cell transplantation to accelerate fracture nonunion repair.

Ryosuke Kuroda, Takahiro Niikura, Tomoyuki Matsumoto, Tomoaki Fukui, Keisuke Oe, Yutaka Mifune, Hironobu Minami, Hiroshi Matsuoka, Kimikazu Yakushijin, Yoshiharu Miyata and 4 more

Open access · goldAbstract readClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.9field-weighted citation impact, top 24% of its field
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

7 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Article
  6. Review
  7. [Advances in Molecular Regulatory Mechanisms of Jaw Repair and Reconstruction].Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition · 2024
    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

14 authors at 3 institutions in 1 country.

Ryosuke Kuroda *Department of Orthopaedic Surgery, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-Cho, Chuo-Ku, Kobe, 650-0017, Japan.
Takahiro Niikura *Department of Orthopaedic Surgery, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-Cho, Chuo-Ku, Kobe, 650-0017, Japan. niikura@tj8.so-net.ne.jp.ORCID http://orcid.org/0000-0003-0951-5812
Tomoyuki MatsumotoDepartment of Orthopaedic Surgery, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-Cho, Chuo-Ku, Kobe, 650-0017, Japan.
Tomoaki FukuiDepartment of Orthopaedic Surgery, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-Cho, Chuo-Ku, Kobe, 650-0017, Japan.
Keisuke OeDepartment of Orthopaedic Surgery, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-Cho, Chuo-Ku, Kobe, 650-0017, Japan.
Yutaka MifuneDepartment of Orthopaedic Surgery, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-Cho, Chuo-Ku, Kobe, 650-0017, Japan.
Hironobu MinamiDivision of Medical Oncology/Hematology, Department of Medicine, Kobe University Hospital and Graduate School of Medicine, Chuo-Ku, Kobe, 650-0017, Japan.
Hiroshi MatsuokaDivision of Medical Oncology/Hematology, Department of Medicine, Kobe University Hospital and Graduate School of Medicine, Chuo-Ku, Kobe, 650-0017, Japan.
Kimikazu YakushijinDivision of Medical Oncology/Hematology, Department of Medicine, Kobe University Hospital and Graduate School of Medicine, Chuo-Ku, Kobe, 650-0017, Japan.
Yoshiharu MiyataDivision of Medical Oncology/Hematology, Department of Medicine, Kobe University Hospital and Graduate School of Medicine, Chuo-Ku, Kobe, 650-0017, Japan.
Shinichiro KawamotoDepartment of Transfusion Medicine and Cell Therapy, Kobe University Hospital, Chuo-Ku, Kobe, 650-0017, Japan.
Tatsuo KagimuraTranslational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe, Chuo-Ku, Kobe, 650-0047, Japan.
Yasuyuki FujitaTranslational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe, Chuo-Ku, Kobe, 650-0047, Japan.
Atsuhiko KawamotoTranslational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe, Chuo-Ku, Kobe, 650-0047, Japan.
Kobe University · JPKobe University Hospital · JPFoundation for Biomedical Research and Innovation · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe previously demonstrated that CD34 + cell transplantation in animals healed intractable fractures via osteogenesis and vasculogenesis; we also demonstrated the safety and efficacy of this cell therapy in an earlier phase I/II clinical trial conducted on seven patients with fracture nonunion. Herein, we present the results of a phase III clinical trial conducted to confirm the results of the previous phase studies using a larger cohort of patients.

methodsCD34 + cells were mobilized via administration of granulocyte colony-stimulating factor, harvested using leukapheresis, and isolated using magnetic cell sorting. Autologous CD34 + cells were transplanted in 15 patients with tibia nonunion and 10 patients with femur nonunion, who were followed up for 52 weeks post transplantation. The main outcome was a reduction in time to heal the tibia in nonunion patients compared with that in historical control patients. We calculated the required number of patients as 15 based on the results of the phase I/II study. An independent data monitoring committee performed the radiographic assessments. Adverse events and medical device failures were recorded.

resultsAll fractures healed during the study period. The time to radiological fracture healing was 2.8 times shorter in patients with CD34 + cell transplantation than in the historical control group (hazard ratio: 2.81 and 95% confidence interval 1.16-6.85); moreover, no safety concerns were observed.

conclusionsOur findings strongly suggest that autologous CD34 + cell transplantation is a novel treatment option for fracture nonunion.

trial registrationUMIN-CTR, UMIN000022814. Registered on 22 June 2016.

Indexed as

Fractures, BoneFractures, UnunitedCell TransplantationFracture HealingGranulocyte Colony-Stimulating FactorHumansTransplantation, AutologousTreatment OutcomeGranulocyte Colony-Stimulating FactorCD34 + cellClinical trialFracture nonunionPhase IIITransplantation

Identifiers

PMID37798633
PMCPMC10557317
OpenAlexW4387359173

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

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 Socratic graph.