title: Autologous intra-arterial infusion of bone marrow mononuclear cells in patients with critical leg ischemia.
abstract: OBJECTIVE
  The injection of bone marrow mononuclear cells (BMMC) into the gastrocnemius muscle has given promising results in patients with critical limb ischemia (CLI). In this article, we have assessed whether a less invasive procedure, i.e. intravascular BMMC infusion, could be effective in this population of patients.
  
  
  METHODS
  A total of 28 limbs in 24 patients with CLI were treated. An amount of 276-700 mL of marrow blood was harvested from posterior iliac crests and BMMC were obtained by standard procedure used for bone marrow transplantation. After performance of digital subtraction angiography, BMMC were injected laterally through a 4 Fr sheet. Primary outcome was efficacy of the procedure measured as healing of defects, frequency of high amputations and change of ischemia grade; among secondary outcomes were safety of the procedure, angiographic changes and changes in quality of life.
  
  
  RESULTS
  One year after treatment, all patients were alive and only 2 patients have undergone high amputation. Eleven of 14 defects have healed (78%) and Fontaine grade of ischemia has changed from median grade 3.5 to median grade 2 (P<0.0001). Collateral vessel development has improved by mean 1.13 and 1.3 points on a four-point semiquantitative scale in calf and foot, respectively (P<0.0001). There were no grade III-IV adverse events. According to the SF-36 quality of life questionnaire, 1 year after the procedure patients have reported significant improvement in all measured items.
  
  
  CONCLUSIONS
  Intra-arterial infusion of BMMC can lead to significant and long-lasting subjective and objective improvements in patients with CLI. The results merit validation by randomized controlled studies in patients with less critical limb ischemia.
authors.affiliation: 2nd Department of Medicine, Cardiology and Angiology, General University Hospital, Prague, Czech Republic. miroslav.chochola@vfn.cz
authors.forename: M
authors.initials: M
authors.lastname: Chochola
authors.forename: R
authors.initials: R
authors.lastname: Pytlík
authors.forename: P
authors.initials: P
authors.lastname: Kobylka
authors.forename: L
authors.initials: L
authors.lastname: Skalická
authors.forename: L
authors.initials: L
authors.lastname: Kideryová
authors.forename: S
authors.initials: S
authors.lastname: Beran
authors.forename: P
authors.initials: P
authors.lastname: Varejka
authors.forename: S
authors.initials: S
authors.lastname: Jirát
authors.forename: J
authors.initials: J
authors.lastname: Køivánek
authors.forename: M
authors.initials: M
authors.lastname: Aschermann
authors.forename: A
authors.initials: A
authors.lastname: Linhart
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D015901:Angiography, Digital Subtraction; D000842:Ankle / Q000098:blood supply; D001132:Arm / Q000098:blood supply; D001785:Blood Gas Monitoring, Transcutaneous; D001794:Blood Pressure; D016026:Bone Marrow Transplantation / Q000009:adverse effects; D003097:Collateral Circulation; D016638:Critical Illness; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007261:Infusions, Intra-Arterial; D007511:Ischemia / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D007866:Leg / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011788:Quality of Life; D012039:Regional Blood Flow; D012086:Reoperation; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014945:Wound Healing