Evidence map›Paper›PMID 30059194›Full record

Trial reportStem cells translational medicine2018

Autologous Granulocyte Colony-Stimulating Factor-Mobilized Peripheral Blood CD34 Positive Cell Transplantation for Hemodialysis Patients with Critical Limb Ischemia: A Prospective Phase II Clinical Trial.

Takayasu Ohtake, Yasuhiro Mochida, Kunihiro Ishioka, Machiko Oka, Kyoko Maesato, Hidekazu Moriya, Sumi Hidaka, Satoshi Higashide, Tetsuya Ioji, Yasuyuki Fujita and 3 more

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

Trial report in Stem cells translational medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 15% 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

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. CD34 positive cells as endothelial progenitor cells in biology and medicine.Frontiers in cell and developmental biology · 2023
    Review
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Review
  19. 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

13 authors at 3 institutions in 1 country.

Takayasu OhtakeDepartment of Kidney Disease and Transplant Center, Shonan Kamakura General Hospital, Kamakura, Japan.ORCID 0000-0002-7009-161X
Yasuhiro MochidaDepartment of Kidney Disease and Transplant Center, Shonan Kamakura General Hospital, Kamakura, Japan.
Kunihiro IshiokaDepartment of Kidney Disease and Transplant Center, Shonan Kamakura General Hospital, Kamakura, Japan.
Machiko OkaDepartment of Kidney Disease and Transplant Center, Shonan Kamakura General Hospital, Kamakura, Japan.
Kyoko MaesatoDepartment of Kidney Disease and Transplant Center, Shonan Kamakura General Hospital, Kamakura, Japan.
Hidekazu MoriyaDepartment of Kidney Disease and Transplant Center, Shonan Kamakura General Hospital, Kamakura, Japan.
Sumi HidakaDepartment of Kidney Disease and Transplant Center, Shonan Kamakura General Hospital, Kamakura, Japan.
Satoshi HigashideTranslational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe, Japan.
Tetsuya IojiTranslational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe, Japan.
Yasuyuki FujitaTranslational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe, Japan.
Atsuhiko KawamotoTranslational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe, Japan.
Masanori FukushimaTranslational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe, Japan.
Shuzo KobayashiDepartment of Kidney Disease and Transplant Center, Shonan Kamakura General Hospital, Kamakura, Japan.
Shonan Kamakura General Hospital · JPFoundation for Biomedical Research and Innovation · JPTranslational Research Informatics Center (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Critical limb ischemia (CLI) is a devastating disease in patients undergoing hemodialysis (HD). Based on the unsatisfactory results of autologous mononuclear cell transplantation for patients with CLI undergoing HD, we conducted a phase II clinical trial to evaluate the safety and efficacy of granulocyte colony-stimulating factor (G-CSF)-mobilized peripheral blood-derived autologous purified CD34 positive (CD34+) cell transplantation for CLI in patients undergoing HD. Six patients with CLI (two with Rutherford category 4 and four with Rutherford category 5) were enrolled. As for primary endpoint, there were no major adverse events related to this therapy. As for efficacy, the amputation-free survival rate was 100% at 1 year after cell therapy. Both rest pain scale and ulcer size were significantly improved as early as 4 weeks after therapy compared with baseline (p < .01), and three out of five ulcers completely healed within 12 weeks after cell transplantation. Clinical severity, including Fontaine scale and Rutherford category, significantly improved at 24 weeks after cell transplantation (p < .05), and further improved at 52 weeks (p < .01) compared with baseline. The improvement rate from CLI stage to non-CLI stage was 83.3% at 52 weeks. Toe skin perfusion pressure and absolute claudication distance were also significantly improved. In conclusion, G-CSF-mobilized peripheral blood CD34+ cell transplantation was safe, feasible, and effective for patients with CLI undergoing HD. Stem Cells Translational Medicine 2018;7:774-782.

Indexed as

AgedAged, 80 and overAmputation, SurgicalAntigens, CD34Cardiovascular DiseasesDisease-Free SurvivalEndothelial Progenitor CellsFemaleGranulocyte Colony-Stimulating FactorHumansIschemiaKidney Failure, ChronicLower ExtremityMaleMiddle AgedPeripheral Arterial DiseaseAntigens, CD34Granulocyte Colony-Stimulating FactorCD34 positive cellsCritical limb ischemiaHemodialysisTransplantation

Identifiers

PMID30059194
PMCPMC6216433
OpenAlexW2886623777

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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 OpenQuestion graph.