Journal of Vascular Surgery
Volume 50, Issue 6 , Pages 1378-1390 , December 2009

Use of autologous bone marrow mononuclear cell implantation therapy as a limb salvage procedure in patients with severe peripheral arterial disease

  • Randall W. Franz, MD, FACS, RVT

      Affiliations

    • Vascular and Vein Center at Grant Medical Center, Columbus, Ohio
    • Corresponding Author InformationReprint requests: Randall W. Franz, MD, FACS, RVT, The Vascular and Vein Center at Grant Medical Center, 285 East State St., Ste. 260, Columbus, OH 43215
  • ,
  • Alan Parks, DO

      Affiliations

    • Doctors Hospital, Columbus, Ohio
  • ,
  • Kaushal J. Shah, MD, RPVI

      Affiliations

    • Vascular and Vein Center at Grant Medical Center, Columbus, Ohio
  • ,
  • Thomas Hankins, CCP

      Affiliations

    • Grant Medical Center, Columbus, Ohio
  • ,
  • Jodi F. Hartman, MS

      Affiliations

    • Orthopaedic Research and Reporting, Ltd., Gahanna, Ohio
  • ,
  • Michelle L. Wright, MPH

      Affiliations

    • Orthopaedic Research and Reporting, Ltd., Gahanna, Ohio

Received 11 June 2009 ,Accepted 30 July 2009.

References 

  1. Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, et al. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA. 2001;286:1317–1324
  2. Tachi Y, Fukui D, Wada Y, Koshikawa M, Shimodaira S, Ikeda U, et al. Changes in angiogenesis-related factors in serum following autologous bone marrow cell implantation for severe limb ischemia. Expert Opin Biol Ther. 2008;8:705–712
  3. Bartsch T, Brehm M, Zeus T, Strauer BE. Autologous mononuclear stem cell transplantation in patients with peripheral occlusive arterial disease. J Cardio Nurs. 2006;21:430–432
  4. Hooi JD, Kester AD, Stoffers HE, Overdijk MM, van Ree JW, Knottnerus JA. Incidence of and risk factors for asymptomatic peripheral arterial occlusive disease: a longitudinal study. Am J Epidemiol. 2001;153:666–672
  5. Cobellis G, Silvestroni A, Lillo S, Sica G, Botti C, Maione C, et al. Long-term effects of repeated autologous transplantation of bone marrow cells in patients affected by peripheral arterial disease. Bone Marrow Transplant. 2008;42:667–672
  6. Napoli C, Farzati B, Sica V, Iannuzzi E, Coppola G, Silvestroni A, et al. Beneficial effects of autologous bone marrow cell infusion and antioxidants/L-arginine in patients with chronic critical limb ischemia. Eur J Cardiol Prev Rehab. 2008;15:709–718
  7. Dillingham TR, Pezzin LE, Mackenzie EJ. Limb amputation and limb deficiency: epidemiology and recent trends in the United States. South Med J. 2002;95:875–883
  8. Goldman R, Rosen M, Brewley B, Golden M. Electrotherapy promotes healing and microcirculation of infrapopliteal ischemic wounds: a prospective pilot study. Adv Skin Wound Care. 2004;17:284–294
  9. Kajiguchi M, Kondo T, Izawa H, Kobayashi M, Yamamoto K, Shintani S, et al. Safety and efficacy of autologous progenitor cell transplantation for therapeutic angiogenesis in patients with critical limb ischemia. Circ J. 2007;71:196–201
  10. Hamano K, Li TS, Kobayashi T, Tanaka N, Kobayashi S, Matsuzaki M, et al. The induction of angiogenesis by the implantation of autologous bone marrow cells: a novel and simple therapeutic method. Surgery. 2001;130:44–54
  11. Esato K, Hamano K, Li TS, Furutani A, Seyama A, Takenaka H, et al. Neovascularization induced by autologous bone marrow cell implantation in peripheral arterial disease. Cell Transplant. 2002;11:747–752
  12. Higashi Y, Kimura M, Hara K, Noma K, Jitsuiki D, Nakagawa K, et al. Autologous bone-marrow mononuclear cell implantation improves endothelium-dependent vasodilation in patients with limb ischemia. Circulation. 2004;109:1215–1218
  13. Iwase T, Nagaya N, Fujii T, Itoh T, Ishibashi-Ueda H, Yamagishi M, et al. Adrenomedullin enhances angiogenic potency of bone marrow transplantation in a rat model of hindlimb ischemia. Circulation. 2005;111:356–362
  14. Tateishi-Yuyama E, Matsubara H, Murohara T, Ikeda U, Shintani S, Masaki H, et al. Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells: a pilot study and a randomised controlled trial. Lancet. 2002;360:427–435
  15. Bartsch T, Brehm M, Zeus T, Kogler G, Wernet P, Strauer BE. Transplantation of autologous mononuclear bone marrow stem cells in patients with peripheral arterial disease (The TAM-PAD study). Clin Res Cardiol. 2007;96:891–899
  16. Hattori R, Matsubara H. Therapeutic angiogenesis for severe ischemic heart diseases by autologous bone marrow cells transplantation. Mol Cell Biochem. 2004;264:151–155
  17. Ikenaga S, Hamano K, Nishida M, Kobayashi T, Li TS, Kobayashi S, et al. Autologous bone marrow implantation induced angiogenesis and improved deteriorated exercise capacity in a rat ischemic hindlimb model. J Surg Res. 2001;96:277–283
  18. Ishida A, Ohya Y, Sakuda H, Ohshiro K, Higashiuesato Y, Nakaema M, et al. Autologous peripheral blood mononuclear cell implantation for patients with peripheral arterial disease improves limb ischemia. Circ J. 2005;69:1260–1265
  19. Isner JM, Asahara T. Angiogenesis and vasculogenesis as therapeutic strategies for postnatal neovascularization. J Clin Invest. 1999;103:1231–1236
  20. Kobayashi T, Hamano K, Li TS, Katoh T, Kobayashi S, Matsuzaki M, et al. Enhancement of angiogenesis by the implantation of self bone marrow cells in a rat ischemic heart model. J Surg Res. 2000;89:189–195
  21. Matoba S, Tatsumi T, Murohara T, Imaizumi T, Katsuda Y, Ito M, et al. Long-term clinical outcome after intramuscular implantation of bone marrow mononuclear cells (Therapeutic Angiogenesis by Cell Transplantation [TACT] trial) in patients with chronic limb ischemia. Am Heart J. 2008;156:1010–1018
  22. Wester T, Jorgensen JJ, Stranden E, Sandbaek G, Tjonnfjord G, Bay D, et al. Treatment with autologous bone marrow mononuclear cells in patients with critical lower limb ischaemia (A pilot study). Scand J Surg. 2008;97:56–62
  23. Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, et al. Recommended standards for reports dealing with lower extremity ischemia: Revised version. J Vasc Surg. 1997;26:517–538
  24. Rutherford RB, Flanigan DP, Gupta SK, Johnston KW, Karmody A, Whittemore AD, et al. Suggested standards for reports dealing with lower extremity ischemia. J Vasc Surg. 1986;4:80–94
  25. Zhang H, Zhang N, Li M, Feng H, Jin W, Zhao H, et al. Therapeutic angiogenesis of bone marrow mononuclear cells (MNCs) and peripheral blood MNCs: transplantation for ischemic hindlimb. Ann Vasc Surg. 2008;22:238–247
  26. Chochola M, Pytlik R, Kobylka P, Skalicka L, Kideryova L, Beran S, et al. Autologous intra-arterial infusion of bone marrow mononuclear cells in patients with critical leg ischemia. Int Angiol. 2008;27:281–290
  27. De Vriese AS, Billiet J, Van Droogenbroeck J, Ghekiere J, De Letter JA. Autologous transplantation of bone marrow mononuclear cells for limb ischemia in a caucasian population with atherosclerosis obliterans. J Intern Med. 2008;263:395–403
  28. Durdu S, Akar AR, Arat M, Sancak T, Eren NT, Ozyurda U. Autologous bone-marrow mononuclear cell implantation for patients with Rutherford grade II-III thromboangiitis obliterans. J Vasc Surg. 2006;44:732–739
  29. Hernandez P, Cortina L, Artaza H, Pol N, Lam RM, Dorticos E, et al. Autologous bone-marrow mononuclear cell implantation in patients with severe lower limb ischaemia: a comparison of using blood cell separator and Ficoll density gradient centrifugation. Atherosclerosis. 2007;194:e52–e56
  30. Miyamoto K, Nishigami K, Nagaya N, Akutsu K, Chiku M, Kamei M, et al. Unblinded pilot study of autologous transplantation of bone marrow mononuclear cells in patients with thromboangiitis obliterans. Circulation. 2006;114:2679–2684
  31. Motukuru V, Suresh KR, Vivekanand V, Raj S, Girija KR. Therapeutic angiogenesis in Buerger's disease (thromboangiitis obliterans) patients with critical limb ischemia by autologous transplantation of bone marrow mononuclear cells. J Vasc Surg. 2008;48(6 Suppl):53S–60S
  32. Van Tongeren RB, Hamming JF, Fibbe WE, Van Weel V, Frerichs SJ, Stiggelbout AM, et al. Intramuscular or combined intramuscular/intra-arterial administration of bone marrow mononuclear cells: a clinical trial in patients with advanced limb ischemia. J Cardiovasc Surg. 2008;49:51–58
  33. Gu YQ, Zhang J, Guo LR, Qi LX, Zhang SW, Xu J, et al. Transplantation of autologous bone marrow mononuclear cells for patients with lower limb ischemia. Chin Med J. 2008;121:963–967
  34. Nizankowski R, Petriczek T, Skotnicki A, Szczeklik A. The treatment of advanced chronic lower limb ischaemia with marrow stem cell autotransplantation. Kardiol Pol. 2005;63:351–360
  35. Saigawa T, Kato K, Ozawa T, Toba K, Makiyama Y, Minagawa S, et al. Clinical application of bone marrow implantation in patients with arteriosclerosis obliterans, and the association between efficacy and the number of implanted bone marrow cells. Circ J. 2004;68:1189–1193
  36. Saito Y, Sasaki K, Katsuda Y, Murohara T, Takeshita Y, Okazaki T, et al. Effect of autologous bone-marrow cell transplantation on ischemic ulcer in patients with Buerger's disease. Circ J. 2007;71:1187–1192
  37. Aulivola B, Hile CN, Hamdan AD, Sheahan MG, Veraldi JR, Skillman JJ, et al. Major lower extremity amputation: outcome of a modern series. Arch Surg. 2004;139:395–399

 Competition of interest: none.

 The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a competition of interest.

PII: S0741-5214(09)01606-1

doi: 10.1016/j.jvs.2009.07.113

Journal of Vascular Surgery
Volume 50, Issue 6 , Pages 1378-1390 , December 2009