Evidence map›Paper›PMID 26526721›Full record

Trial reportJournal of translational medicine2015

Autologous immuno magnetically selected CD133+ stem cells in the treatment of no-option critical limb ischemia: clinical and contrast enhanced ultrasound assessed results in eight patients.

Vittorio Arici, Cesare Perotti, Calliada Fabrizio, Claudia Del Fante, Franco Ragni, Francesco Alessandrino, Gianluca Viarengo, Michele Pagani, Alessia Moia, Carmine Tinelli and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Journal of translational medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01595776 (Autologous Immunomagnetic Selected cd133+ Cells in the Treatment of No-option Critical Limb Ischemia), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
–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.

NCT01595776 phase1 / phase2completednot on this map

Autologous Immunomagnetic Selected cd133+ Cells in the Treatment of No-option Critical Limb Ischemia: Clinical and Ceus Assessed Results.

TypeinterventionalSponsorFondazione IRCCS Policlinico San Matteo di PaviaRan2009 to 2011Enrolled8ConditionsCritical Limb IschemiaArmsEndothelial progenitor cells intramuscular implant
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Therapeutic Potential of Endothelial Progenitor Cells in Pulmonary Diseases.American journal of respiratory cell and molecular biology · 2021
    Review
  5. Review
  6. Article
  7. Observational
  8. Review
  9. Article
  10. Article
  11. Article
  12. Review
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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

11 authors.

Vittorio AriciVascular Surgery Unit, Fondazione IRCCS Policlinico S. Matteo and University of Pavia, Piazzale Golgi 19, 27100, Pavia, Italy. vittorio.arici@gmail.com.
Cesare PerottiHaemotransfusional Service, Fondazione IRCCS Policlinico S. Matteo and University of Pavia, Pavia, Italy. c.perotti@smatteo.pv.it.
Calliada FabrizioRadiology Service, Fondazione IRCCS Policlinico S. Matteo and University of Pavia, Pavia, Italy. f.calliada@smatteo.pv.it.
Claudia Del FanteHaemotransfusional Service, Fondazione IRCCS Policlinico S. Matteo and University of Pavia, Pavia, Italy. c.delfante@smatteo.pv.it.
Franco RagniVascular Surgery Unit, Fondazione IRCCS Policlinico S. Matteo and University of Pavia, Piazzale Golgi 19, 27100, Pavia, Italy. f.ragni@smatteo.pv.it.
Francesco AlessandrinoRadiology Service, Fondazione IRCCS Policlinico S. Matteo and University of Pavia, Pavia, Italy. pragia@hotmail.com.
Gianluca ViarengoHaemotransfusional Service, Fondazione IRCCS Policlinico S. Matteo and University of Pavia, Pavia, Italy. lucaviare@gmail.com.
Michele PaganiAnesthesiology and Intensive Care Unit 2, Fondazione IRCCS Policlinico S. Matteo and University of Pavia, Pavia, Italy. m.pagani@smatteo.pv.it.
Alessia MoiaVascular Surgery Unit, Fondazione IRCCS Policlinico S. Matteo and University of Pavia, Piazzale Golgi 19, 27100, Pavia, Italy. alessia.moia83@gmail.com.
Carmine TinelliStatistics and Epidemiology Service, Fondazione IRCCS Policlinico S. Matteo and University of Pavia, Pavia, Italy. c.tinelli@smatteo.pv.it.
Antonio BozzaniVascular Surgery Unit, Fondazione IRCCS Policlinico S. Matteo and University of Pavia, Piazzale Golgi 19, 27100, Pavia, Italy. a.bozzani@smatteo.pv.it.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesDemonstrate the safety and effectiveness of highly purified CD133+ autologous stem cells in critical limb ischemia (CLI).

designProspective single-center not randomized. Clinicaltrials.gov identifier: NCT01595776

methodsEight patients with a history of stable CLI were enrolled in a period of 2 years. After bone marrow stimulation and single leukapheresis collection, CD133+ immunomagnetic cell selection was performed. CD133+ cells in buffer phosphate suspension was administered intramuscularly. Muscular and arterial contrast enhanced ultra sound (CEUS), lesion evolution and pain management were assessed preoperatively and 3, 6 and 12 months after the implant.

resultsNo patient had early or late complications related to the procedure. Two patients (25 %) didn't get any relief from the treatment and underwent major amputation. Six patients (75 %) had a complete healing of the wounds, rest pain cessation and walking recovery. An increase in CEUS values was shown in all eight patients at 6 months and in the six clinical healed patients at 12 months and had statistical relevance.

conclusionsHighly purified autologous CD133+ cells can stimulate neo-angiogenesis, as based on clinical and CEUS data.

Indexed as

Stem Cell TransplantationAC133 AntigenAdultAmputation, SurgicalAntigens, CDBone MarrowExtremitiesFemaleFlow CytometryGlycoproteinsGranulocyte Colony-Stimulating FactorHumansImmunomagnetic SeparationIschemiaMaleMiddle AgedAC133 AntigenAntigens, CDGlycoproteinsGranulocyte Colony-Stimulating FactorPeptidesPROM1 protein, human

Identifiers

PMID26526721
PMCPMC4630831

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Registered trials

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.