title: Critical limb ischaemia and the response to bone marrow-derived cell therapy according to tcPO2measurement.
abstract: Cell therapy is an emerging potential biotherapy for critical limb ischaemia (CLI) patients who are not eligible for revascularization. However, the findings on this technique's efficacy are inconsistent. Trials investigating this topic focused on the more severe CLI patients who were often beyond any therapy. Therefore, identifying those who may truly benefit from cell transplantation is now warranted. To this end, we studied the prognostic value of tcPO2for major amputation after 1 year in patients treated with bone marrow-derived cells.
  
  
  
  CLI patients ineligible for revascularization were included in a cell-therapy pilot study. On inclusion, patients underwent tcPO2measurement in supine and sitting positions. For a tcPO2< 10 mmHg in the supine position, the vascular reserve was defined by tcPO2> 30 mmHg in the sitting position. Patients were administered intramuscular injections of mononuclear cells derived from aspirated bone marrow.
  
  
  
  In total, 25 patients (a lower limbs) were included for analysis. At inclusion, 11 lower limbs had tcPO2at rest > 10 mmHg, and 16 lower limbs had a tcPO2< 10 mmHg. The success probability for cell therapy was 0.79 (95 % CI 0.38-0.94) and 0.44 (95 % CI 0.18-0.67), respectively (p = 0.1). Of the 16 limbs with tcPO2 < 10 mmHg, the success rate was considerably higher in patients demonstrating a tcPO2increase in a sitting position of over 30 mmHg (6/8, success probability 0.71, 95 % CI 0.26-0.92) compared to those without (2/8, success probability 0.15, 95 % CI 0.01-0.48, p = 0.03).
  
  
  
  For patients with chronic CLI for whom cellular therapy is a therapeutic option, a tcPO2< 10 mmHg at rest, without vascular reserve (i. e. < 30 mmHg when sitting), is a prognostic indicator for poor outcome. .
authors.affiliation: 1 Department of Vascular Medicine, University Hospital Grenoble-Alpes, France.
authors.forename: Mario
authors.initials: M
authors.lastname: Maufus
authors.affiliation: 2 Department of Vascular Medicine, University Hospital Amiens, France.|3 Université Grenoble Alpes - CNRS, TIMC-IMAG UMR 5525/Themas, Grenoble, France.
authors.forename: Marie Antoinette
authors.initials: MA
authors.lastname: Sevestre-Pietri
authors.affiliation: 4 Department of Vascular Surgery, University Hospital Grenoble-Alpes, France.
authors.forename: Carmine
authors.initials: C
authors.lastname: Sessa
authors.affiliation: 5 Cell Therapy Unit, University Hospital Reims, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Pignon
authors.affiliation: 6 Cell Therapy Unit, University Hospital Grenoble-Alpes, France.|7 Etablissement Français du Sang, Rhône-Alpes Grenoble, France.
authors.forename: Harald
authors.initials: H
authors.lastname: Egelhofer
authors.affiliation: 2 Department of Vascular Medicine, University Hospital Amiens, France.
authors.forename: Stephane
authors.initials: S
authors.lastname: Dupas
authors.affiliation: 8 Hematology Laboratory, University Hospital Reims, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Nguyen
authors.affiliation: 9 Centre of Clinical Research, University Hospital Grenoble-Alpes, France.
authors.forename: Celine
authors.initials: C
authors.lastname: Genty
authors.affiliation: 1 Department of Vascular Medicine, University Hospital Grenoble-Alpes, France.|3 Université Grenoble Alpes - CNRS, TIMC-IMAG UMR 5525/Themas, Grenoble, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Pernod
mesh_terms: D000368:Aged; D000671:Amputation, Surgical; D015415:Biomarkers / Q000097:blood; D001785:Blood Gas Monitoring, Transcutaneous; D016026:Bone Marrow Transplantation / Q000009:adverse effects; D016638:Critical Illness; D005240:Feasibility Studies; D005260:Female; D005602:France; D006801:Humans; D007273:Injections, Intramuscular; D007511:Ischemia / Q000097:blood / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D023821:Limb Salvage; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D010100:Oxygen / Q000097:blood*; D010313:Partial Pressure; D056888:Patient Positioning; D018579:Patient Selection; D010865:Pilot Projects; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012086:Reoperation; D012307:Risk Factors; D016683:Supine Position; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D010100:Oxygen
keywords: CLI; Critical limb ischaemia; TcPO2; cell therapy