title: Unblinded pilot study of autologous transplantation of bone marrow mononuclear cells in patients with thromboangiitis obliterans.
abstract: BACKGROUND
  The short-term clinical benefits of bone marrow mononuclear cell transplantation have been shown in patients with critical limb ischemia. The purpose of this study was to assess the long-term safety and efficacy of bone marrow mononuclear cell transplantation in patients with thromboangiitis obliterans.
  
  
  RESULTS
  Eleven limbs (3 with rest pain and 8 with an ischemic ulcer) of 8 patients were treated by bone marrow mononuclear cell transplantation. The patients were followed up for clinical events for a mean of 684+/-549 days (range 103 to 1466 days). At 4 weeks, improvement in pain was observed in all 11 limbs, with complete relief in 4 (36%). Pain scale (visual analog scale) score decreased from 5.1+/-0.7 to 1.5+/-1.3. An improvement in skin ulcers was observed in all 8 limbs with an ischemic ulcer, with complete healing in 7 (88%). During the follow-up, however, clinical events occurred in 4 of the 8 patients. The first patient suffered sudden death at 20 months after transplantation at 30 years of age. The second patient with an incomplete healing of a skin ulcer showed worsening of the lesion at 4 months. The third patient showed worsening of rest pain at 8 months. The last patient developed an arteriovenous shunt in the foot at 7 months, which spontaneously regressed by 1 year.
  
  
  CONCLUSIONS
  In the present unblinded and uncontrolled pilot study, long-term adverse events, including death and unfavorable angiogenesis, were observed in half of the patients receiving bone marrow mononuclear cell transplantation. Given the current incomplete knowledge of the safety and efficacy of this strategy, careful long-term monitoring is required for future patients receiving this treatment.
authors.affiliation: Department of Medicine, National Cardiovascular Center, 5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Miyamoto
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Nishigami
authors.forename: Noritoshi
authors.initials: N
authors.lastname: Nagaya
authors.forename: Koichi
authors.initials: K
authors.lastname: Akutsu
authors.forename: Masaaki
authors.initials: M
authors.lastname: Chiku
authors.forename: Masataka
authors.initials: M
authors.lastname: Kamei
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Soma
authors.forename: Shigeki
authors.initials: S
authors.lastname: Miyata
authors.forename: Masahiro
authors.initials: M
authors.lastname: Higashi
authors.forename: Ryoichi
authors.initials: R
authors.lastname: Tanaka
authors.forename: Takeshi
authors.initials: T
authors.lastname: Nakatani
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nonogi
authors.forename: Satoshi
authors.initials: S
authors.lastname: Takeshita
mesh_terms: D000328:Adult; D016026:Bone Marrow Transplantation / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007963:Leukocytes, Mononuclear / Q000637:transplantation*; D008297:Male; D008875:Middle Aged; D018919:Neovascularization, Physiologic; D010865:Pilot Projects; D013919:Thromboangiitis Obliterans / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D014182:Transplantation, Autologous