Evidence mapPaperPMID 24307697Full record

Trial reportStem cells translational medicine2014

Local transplantation of granulocyte colony stimulating factor-mobilized CD34+ cells for patients with femoral and tibial nonunion: pilot clinical trial.

Ryosuke Kuroda, Tomoyuki Matsumoto, Takahiro Niikura, Yohei Kawakami, Tomoaki Fukui, Sang Yang Lee, Yutaka Mifune, Shin Kawamata, Masanori Fukushima, Takayuki Asahara and 2 more

Open access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Stem cells translational medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
4.3field-weighted citation impact, top 6% 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

21 citing papers in PubMed, 49 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Trauma and Stem Cells: Biology and Potential Therapeutic Implications.International journal of molecular sciences · 2017
    Review
  13. Article
  14. Review
  15. Tissue Engineering in Orthopaedics.The Journal of bone and joint surgery. American volume · 2016
    Review
  16. Stem and progenitor cells: advancing bone tissue engineering.Drug delivery and translational research · 2016
    Review
  17. Review
  18. Review
  19. Article
  20. 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

12 authors at 3 institutions in 1 country.

Ryosuke KurodaDepartment of Orthopedic Surgery, Kobe University Graduate School of Medicine, Kobe, Japan; Unit of Regenerative Medicine and Group of Vascular Regeneration Research, Institute of Biomedical Research and Innovation, Kobe, Japan; Department of Cell Therapy Development, Foundation for Biomedical Research and Innovation, Kobe, Japan; Translational Research Informatics Center, Kobe, Japan; Department of Regenerative Medicine Science, Tokai University School of Medicine, Tokyo, Japan.
Tomoyuki Matsumoto
Takahiro Niikura
Yohei Kawakami
Tomoaki Fukui
Sang Yang Lee
Yutaka Mifune
Shin Kawamata
Masanori Fukushima
Takayuki Asahara
Atsuhiko Kawamoto
Masahiro Kurosaka
Foundation for Biomedical Research and Innovation · JPKobe University · JPTranslational Research Informatics Center (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Most bone fractures typically heal, although a significant proportion (5%-10%) of fractures fail to heal, resulting in delayed union or persistent nonunion. Some preclinical evidence shows the therapeutic potential of peripheral blood CD34(+) cells, a hematopoietic/endothelial progenitor cell-enriched population, for bone fracture healing; however, clinical outcome following transplantation of CD34(+) cells in patients with fracture has never been reported. We report a phase I/IIa clinical trial regarding transplantation of autologous, granulocyte colony stimulating factor-mobilized CD34(+) cells with atelocollagen scaffold for patients with femoral or tibial fracture nonunion (n = 7). The primary endpoint of this study is radiological fracture healing (union) by evaluating anteroposterior and lateral views at week 12 following cell therapy. For the safety evaluation, incidence, severity, and outcome of all adverse events were recorded. Radiological fracture healing at week 12 was achieved in five of seven cases (71.4%), which was greater than the threshold (18.1%) predefined by the historical outcome of the standard of care. The interval between cell transplantation and union, the secondary endpoint, was 12.6 ± 5.4 weeks (range, 8-24 weeks) for clinical healing and 16.1 ± 10.2 weeks (range, 8-36 weeks) for radiological healing. Neither deaths nor life-threatening adverse events were observed during the 1-year follow-up after the cell therapy. These results suggest feasibility, safety, and potential effectiveness of CD34(+) cell therapy in patients with nonunion.

Indexed as

AdultAntigens, CD34FemaleFemoral FracturesFracture HealingFractures, UnunitedGranulocyte Colony-Stimulating FactorHematopoietic Stem Cell MobilizationHumansMaleMiddle AgedPilot ProjectsRadiographyStem CellsStem Cell TransplantationTibial FracturesAntigens, CD34Granulocyte Colony-Stimulating FactorCD34+ cellsClinical trialG-CSFNonunionPeripheral blood

Identifiers

PMID24307697
PMCPMC3902290
OpenAlexW2006211029

What Socratic holds

Textmetadata
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.