title: Intra-arterial allogeneic mesenchymal stem cells for critical limb ischemia are safe and efficacious: report of a phase I study.
abstract: BACKGROUND
  Critical limb ischemia (CLI) caused by peripheral arterial disease is associated with significant morbidity and mortality. This condition is associated with a 30 % amputation rate as well as mortality levels which might be as high as 25 %. There is no pharmacological therapy available, but several reports have suggested that mesenchymal stem cells (MSCs) may be a useful therapeutic option.
  
  
  METHODS
  This study, done at a university hospital, evaluated 13 patients for a phase I trial to investigate the safety and efficacy of intra-arterial MSCs in CLI patients. Eight patients with ten affected limbs were recruited for the study. As two patients (three limbs) died of ischemic cardiac events during the 6-month follow-up period, seven limbs were finally evaluated for the study.
  
  
  RESULTS
  There was significant pain relief. Visual analog scale (VAS) scores decreased from 2.29 ± 0.29 to 0.5 ± 0.34 (p < 0.05), ankle brachial pressure index (ABPI) increased significantly from 0.56 ± 0.02 to 0.67 ± 0.021 (p < 0.01), and transcutaneous oxygen pressure (TcPO2) also increased significantly in the foot from 13.57 ± 3.63 to 38 ± 3.47. Similar improvement was seen in the leg as well as the thigh. There was 86 % limb salvage and six of seven ulcers showed complete or partial healing.
  
  
  CONCLUSIONS
  It was concluded that intra-arterial MSCs could be safely administered to patients with CLI and was associated with significant therapeutic benefits.
authors.affiliation: Stempeutics Research Malaysia Sdn. Bhd., Technology Park Malaysia, 57000, Kuala Lumpur, Malaysia. anjan.das@stempeutics.com.my
authors.forename: Anjan Kumar
authors.initials: AK
authors.lastname: Das
authors.forename: Basri Johan Jeet
authors.initials: BJ
authors.lastname: Bin Abdullah
authors.forename: S S
authors.initials: SS
authors.lastname: Dhillon
authors.forename: A
authors.initials: A
authors.lastname: Vijanari
authors.forename: C H
authors.initials: CH
authors.lastname: Anoop
authors.forename: Pawan Kumar
authors.initials: PK
authors.lastname: Gupta
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D055109:Ankle Brachial Index; D016026:Bone Marrow Transplantation / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007511:Ischemia / Q000209:etiology / Q000601:surgery*; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation / Q000379:methods*; D008875:Middle Aged; D010147:Pain Measurement; D058729:Peripheral Arterial Disease / Q000150:complications*; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult