Local intramuscular transplantation of autologous mononuclear cells for critical lower limb ischaemia

Cochrane Database of Systematic Reviews

Volumn 2014, Issue 12, 2014, Pages

  Moazzami, Kasra ^a   Moazzami, Bobak ^b   Roohi, Aria ^b   Nedjat, Saharnaz ^c,d   Dolmatova, Elena ^a  

^a MASSACHUSETTS GENERAL HOSPITAL   (United States)

^b BABOL UNIVERSITY OF MEDICAL SCIENCES   (Iran)

^c TEHRAN UNIVERSITY OF MEDICAL SCIENCES   (Iran)

^d TEHRAN UNIVERSITY OF MEDICAL SCIENCES   (Iran)

Author keywords

[No Author keywords available]

Indexed keywords

GRANULOCYTE COLONY STIMULATING FACTOR; PROSTAGLANDIN E1; VASODILATOR AGENT;

ANKLE BRACHIAL INDEX; AUTOTRANSPLANTATION; BLOOD CELL; BONE MARROW DERIVED MONONUCLEAR CELL; CELL TRANSPLANTATION; CLINICAL EFFECTIVENESS; CONSERVATIVE TREATMENT; HUMAN; LEG AMPUTATION; LEG ISCHEMIA; LEG PAIN; MORTALITY; PAIN-FREE WALKING DISTANCE; PATIENT SAFETY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SYSTEMATIC REVIEW; WALKING; ADULT; AMPUTATION; BONE MARROW TRANSPLANTATION; COMPLICATION; INTRAMUSCULAR DRUG ADMINISTRATION; ISCHEMIA; LEG; MONONUCLEAR CELL; PAIN MEASUREMENT; PERIPHERAL VASCULAR DISEASE; PROCEDURES; TRANSPLANTATION; UTILIZATION; VASCULARIZATION; METHODOLOGY; PAIN ASSESSMENT;

ADULT; ALPROSTADIL; AMPUTATION; ANKLE BRACHIAL INDEX; BONE MARROW TRANSPLANTATION; GRANULOCYTE COLONY-STIMULATING FACTOR; HUMANS; INJECTIONS, INTRAMUSCULAR; ISCHEMIA; LEG; LEUKOCYTES, MONONUCLEAR; PAIN MEASUREMENT; PERIPHERAL VASCULAR DISEASES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TRANSPLANTATION, AUTOLOGOUS; VASODILATOR AGENTS;

EID: 84925226745     PISSN: None     EISSN: 1469493X     Source Type: Journal    
DOI: 10.1002/14651858.CD008347.pub3     Document Type: Review

References (88)

1. Barc P, Skora J, Pupka A, Turkiewicz D, Dorobisz AT, Garcarek J, et al. Bone-marrow cells in therapy of critical limb ischaemia of lower extremities - own experience. Acta Angiologica 2006;12(4):155-66.
2. Huang P, Li S, Han M, Xiao Z, Yang R, Han ZC. Autologous transplantation of granulocyte colony-stimulating factor-mobilized peripheral blood mononuclear cells improves critical limb ischemia in diabetes. Diabetes Care 2005;28(9):2155-60.
3. Arai M, Misao Y, Nagai H, Kawasaki M, Nagashima K, Suzuki K, et al. Granulocyte colony-stimulating factor: a noninvasive regeneration therapy for treating atherosclerotic peripheral artery disease. Circulation Journal 2006;70(9):1093-8.
4. 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). Clinical Research in Cardiology 2007;96(12):891-9.
5. Benoit E, O'Donnell TF Jr, Iafrati MD, Asher E, Bandyk DF, Hallett JW, et al. The role of amputation as an outcome measure in cellular therapy for critical limb ischemia: implications for clinical trial design. Journal of Translational Medicine 2011;9:165.
6. Amann B, Lüdemann C, Rückert R, Lawall H, Liesenfeld B, Schneider M, et al. Design and rationale of a randomized, double-blind, placebo-controlled phase III study for autologous bone marrow cell transplantation in critical limb ischemia: the BONe Marrow Outcomes Trial in Critical Limb Ischemia (BONMOT-CLI). Vasa 2008;37(4):319-25.
7. Luedemann C, Amann B, Rueckert R, Ratei R, Schmidt-Lucke JA. Induction of arteriogenesis by autologous bone marrow transplantation (aBMT) in critical limb ischemia (CLI): the BONMOT 1 and 2 (BOne MarrOw Transplantation) studies. European Heart Journal. 2008; Vol. 29 Suppl 1:144.
8. Capiod JC, Tournois C, Vitry F, Sevestre MA, Daliphard S, Reix T, et al. Characterization and comparison of bone marrow and peripheral blood mononuclear cells used for cellular therapy in critical leg ischaemia: towards a new cellular product. Vox Sanguinis 2009;96(3):256-65.
9. Chen B, Lu DB, Liang ZW, Jiang YZ, Wang FH, Wu QN, et al.[Autologous bone marrow mesenchymal stem cell transplantation for treatment of diabetic foot following amplification in vitro]. Journal of Clinical Rehabilitative Tissue Engineering Research 2009;13:6227-30.
10. Choi ET, Geraghty P, Cooke C, Schechtman K, Link D, Chambers CM, et al. Stem cell mobilization to treat severe peripheral artery disease (STEMPAD). Vascular Annual Meeting 2012.
11. 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 Transplantation 2008;42(10):667-72.
12. Dash NR, Dash SN, Routray P, Mohapatra S, Mohapatra PC. Targeting nonhealing ulcers of lower extremity in human through autologous bone marrow-derived mesenchymal stem cells. Rejuvenation Research 2009;12(5):359-66.
13. Debin L, Youzhao J, Ziwen L, Xiaoyan L, Zhonghui Z, Bing C. Autologous transplantation of bone marrow mesenchymal stem cells on diabetic patients with lower limb ischemia. Journal of Medical Colleges of PLA 2008;23:106-15.
14. Dong Z, Chen B, Fu W, Wang Y, Guo D, Wei Z, et al. Transplantation of purified CD34+ cells in the treatment of critical limb ischemia. Journal of Vascular Surgery 2013;58(2):404-11.
15. Doudar N, El AM, Abdel SS. Stem cell implantation in the treatment of peripheral vascular disease. Vox Sang 2013;105:290.
16. Dubsky M, Jirkovska A, Bem R, Fejfarova V, Pagacova L, Sixta B, et al. Both autologous bone marrow mononuclear cell and peripheral blood progenitor cell therapies similarly improve ischaemia in patients with diabetic foot in comparison with control treatment. Diabetes/Metabolism Research Reviews 2013;29(5):369-76.
17. Gu Y, Zhang J, Qi L. [Effective autologous bone marrow stem cell dosage for treatment of severe lower limb ischemia] [Chinese]. Chung-Kuo Hsiu Fu Chung Chien Wai Ko Tsa Chih/Chinese Journal of Reparative and Reconstructive Surgery 2006;20(5):504-6.
18. Gu Y, Zhang J, Qi L. [Comparative study on autologous implantation between bone marrow stem cells and peripheral blood stem cells for treatment of lower limb ischemia] [Chinese]. Chinese Journal of Reparative and Reconstructive Surgery 2007;21(7):675-8.
19. 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. Chinese Medical Journal 2008;121(11):963-7.
20. Gupta PK, Chullikana A, Parakh R, Desai S, Das A, Gottipamula S, et al. A double blind randomized placebo controlled phase I/II study assessing the safety and efficacy of allogeneic bone marrow derived mesenchymal stem cell in critical limb ischemia. Journal of Translational Medicine 2013;11:143.
21. Gurunathan Mani S, Raju R, Kuppu Sampath V. Multicentre randomised clinical trial on the role of autologous bone-marrow aspirate-concentrate (BMAC)/CD34/(EPC) in non-reconstructable critically. The Vascular Society of Great Britain and Ireland Yearbook 2009:56.
22. 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(2):e52-6.
23. Higashi Y, Miyazaki M, Goto C, Sanada H, Sueda T, Chayama K. Sarpogrelate hydrochloride, a selective 5-hydroxytryptamine2A antagonist, augments autologous bone marrow mononuclear cell implantation-induced improvement in endothelium-dependent vasodilation in patients with critical limb ischemia. Journal of Cardiovascular Pharmacology 2010;55(1):56-61.
24. Holzinger C, Zuckermann A, Kopp C, Schollhammer A, Imhof M, Zwolfer W, et al. Treatment of non-healing skin ulcers with autologous activated mononuclear cells. European Journal of Vascular Surgery 1994;8(3):351-6.
25. Huang PP, Yang XF, Li SZ, Wen JC, Zhang Y, Han ZC. Randomised comparison of G-CSF-mobilized peripheral blood mononuclear cells versus bone marrow-mononuclear cells for the treatment of patients with lower limb arteriosclerosis obliterans. Thrombosis and Haemostasis 2007;98(6):1335-42.
26. Iafrati MD, Hallett JW, Geils G, Pearl G, Lumsden A, Peden E, et al. Early results and lessons learned from a multicenter, randomized, double-blind trial of bone marrow aspirate concentrate in critical limb ischemia. Journal of Vascular Surgery 2011;54(6):1650-8.
27. Iafrati MDB, Pearl A. Bone marrow aspirate concentrate in critical limb ischemia: Results of a multicenter randomized double-blind trial. Journal of Vascular Surgery 2010;52:1123.
28. Han ZC, Huang P, Li S. Autologous peripheral blood stem cell implantation as therapeutic angiogenesis for severe limb ischemia. Blood 2004;104:130b.
29. NCT00371371. Intra-arterial stem cell therapy for patients with chronic limb ischemia (CLI) (JUVENTAS). www.clinicaltrials.gov/ct2/show/NCT00371371 (accessed November 2009).
30. Sprengers RW, Moll FL, Teraa M, Verhaar MC, JUVENTAS Study Group. Rationale and design of the JUVENTAS trial for repeated intra-arterial infusion of autologous bone marrow-derived mononuclear cells in patients with critical limb ischemia. Journal of Vascular Surgery 2010;51(6):1564-8.
31. Kirana S, Stratmann B, Lammers D, Minartz P, Negrean M, Stirban A, et al. Autologous tissue repair cells (TRC) in the treatment of ischemia induced chronic tissue ulcers of diabetic foot patients without option of revascularisation: first year experiences. Medizinische Klinik 2007;102:80.
32. Kirana S, Stratmann B, Prante C, Prohaska W, Koerperich H, Lammers D, et al. Autologous stem cell therapy in the treatment of limb ischaemia induced chronic tissue ulcers of diabetic foot patients. International Journal of Clinical Practice 2012;66(4):384-93.
33. Klepanec A, Vulev I, Mistri KM, Altaner C, Necpal R, Madaric J. Randomized comparison of intra-arterial and intramuscular mesenchymal stem cells therapy in patients with critical limb ischemia: 3-month results. American Journal of Roentgenology 2011;196:A284.
34. Lasala GP, Silva JA, Minguell JJ. Therapeutic angiogenesis in patients with severe limb ischemia by transplantation of an autologous bone marrow-derived combination stem cell product. Journal of the American College of Cardiology 2011;57:E2020.
35. Li M, Zhou H, Jin X, Wang M, Zhang S, Xu L. Autologous bone marrow mononuclear cells transplant in patients with critical leg ischemia: preliminary clinical results. Experimental and Clinical Transplantation 2013;11(5):435-9.
36. Lu XX, Yin Z, Jin X, Wu XJ, Hou XQ, Song YB, et al. Autologous bone marrow stem cell transplantation in treatment of 60 cases of lower limb ischemia [Chinese]. Journal of Clinical Rehabilitative Tissue Engineering Research 2008;12(29):5653-7.
37. Lu D, Chen B, Liang Z, Deng W, Jiang Y, Li S, et al. Comparison of bone marrow mesenchymal stem cells with bone marrow-derived mononuclear cells for treatment of diabetic critical limb ischemia and foot ulcer: a double-blind, randomized, controlled trial. Diabetes Research and Clinical Practice 2011;92(1):26-36.
38. Madaric J, Klepanec A, Mistrik M, Altaner C, Valachovicova M, Necpal R. Autologous bone marrow cells transplantation in patients with advanced critical limb ischemia: no difference in intra-arterial and intramuscular application. Journal of the American College of Cardiology 2011;57(14 Suppl 1):E1473.
39. Madaric JK. Higher CD34+ cells concentration and lower degree of inflammation are associated with better therapeutic response to autologous bone marrow cells application in patients with critical limb ischemia. Journal of the American College of Cardiology 2011;58:B150.
40. Mohammadzadeh L, Samedanifard SH, Keshavarzi A, Alimoghaddam K, Larijani B, Ghavamzadeh A, et al. Therapeutic outcomes of transplanting autologous granulocyte colony-stimulating factor-mobilised peripheral mononuclear cells in diabetic patients with critical limb ischaemia. Experimental and Clinical Endocrinology and Diabetes 2013;121(1):48-53.
41. 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. European Journal of Cardiovascular Prevention and Rehabilitation 2008;15(6):709-18.
42. NCT00282646. Safety and feasibility study of autologous bone marrow cell transplantation in patients with PAOD. www.clinicaltrials.gov/ct/show/NCT00282646?order=1 (accessed November 2009).
43. NCT00498069. Study of autologous bone marrow concentrate for the treatment of CLI. http://clinicaltrials.gov/ct2/show/NCT00498069?term=critical+limb&rank=25 (accessed November 2009).
44. NCT00539266. Autologous bone marrow-derived mononuclear cells for therapeutic arteriogenesis in patients with limb ischemia (ABC). www.clinicaltrials.gov/ct2/show/NCT00539266?term=critical+limb&rank=36 (accessed November 2009).
45. NCT00595257. Feasability study of autologous bone marrow aspirate concentrate for treatment of CLI. www.clinicaltrials.gov/ct2/show/NCT00595257?term=stem+cell+AND+limb+ischaemia&rank=9 (accessed November 2009).
46. NCT00616980. Injection of autologous CD34-positive cells for critical limb ischemia (ACT34-CLI). www.clinicaltrials.gov/ct2/show/NCT00616980?term=critical+limb&rank=2 (accessed November 2009).
47. NCT00904501. Bone marrow autograft in limb ischemia (BALI). www.clinicaltrials.gov/show/NCT00904501 (accessed November 2009).
48. NCT00913900. Safety study of adult stem cells to treat patients with severe leg artery disease (SCRIPT-CLI). clinicaltrials.gov/ct2/show/NCT00913900?term=nct00913900&rank=1 (accessed November 2009).
49. NCT00922389. A clinical trial on diabetic foot using peripheral blood derived stem cells for treating critical limb ischemia. www.clinicaltrials.gov/ct2/show/NCT00922389?term=nct00922389&rank=1 (accessed October 2014).
50. NCT00955669. Comparison of autologous mesenchymal stem cells and mononuclear cells on diabetic critical limb ischemia and foot ulcer. www.clinicaltrials.gov/ct2/show/NCT00955669?term=nct00955669&rank=1 (accessed October 2014).
51. NCT01049919. Safety and efficacy study of autologous concentrated bone marrow aspirate (cBMA) for critical limb ischemia (CLI). www.clinicaltrials.gov/ct2/show/NCT01049919?term=NCT01049919&rank=1 (accessed October 2014).
52. NCT01245335. Bone marrow aspirate concentrate (BMAC) for treatment of critical limb ischemia (CLI). www.clinicaltrials.gov/ct2/show/NCT01245335?term=NCT01245335&rank=1 (accessed October 2014).
53. Ozturk A, Kucukardali Y, Tangi F, Erikci A, Uzun G, Bashekim C, et al. Therapeutical potential of autologous peripheral blood mononuclear cell transplantation in patients with type 2 diabetic critical limb ischemia. Journal of Diabetes Complications 2012;26(1):29-33.
54. Pawan K, Anoop CH, Seetharam RN, Das AK, Majumdar AS, Pherwani A. A randomized, double blind, placebo controlled, single dose, phase I/II study using adult bone marrow derived allogeneic mesenchymal stem cells in patients with critical limb ischemia. Abstracts of the European Society for Vascular Surgery XXVI Annual Meeting. 2012:154.
55. NCT00392509. ALDHbr cells for critical limb ischemia, randomized trial (CLI-001). www.clinicaltrials.gov/ct2/show/NCT00392509?term=stem+cell+AND+limb+ischaemia&rank=5 (accessed November 2009).
56. Perin EC, Silva G, Gahremanpour A, Canales J, Zheng Y, Cabreira-Hansen MG, et al. A randomized, controlled study of autologous therapy with bone marrow-derived aldehyde dehydrogenase bright cells in patients with critical limb ischemia. Catheter Cardiovasc Interventions 2011;78(7):1060-7.
57. NCT00468000. Use of vascular repair cells (VRC) in patients with peripheral arterial disease to treat critical limb ischemia (RESTORE-CLI). www.clinicaltrials.gov/ct2/show/NCT00468000?term=critical+limb&rank=7 (accessed November 2009).
58. Powell RJ, Marston WA, Berceli SA, Guzman R, Henry TD, Longcore AT, et al. Cellular therapy with Ixmyelocel-T to treat critical limb ischemia: the randomized, double-blind, placebo-controlled RESTORE-CLI trial. Molecular Therapy: the Journal of the American Society of Gene Therapy 2012;20(6):1280-6.
59. Powell RJC. Interim analysis results from the RESTORE-CLI, a randomized, double-blind multicenter phase II trial comparing expanded autologous bone marrow-derived tissue repair cells and placebo in patients with critical limb ischemia. Journal of Vascular Surgery 2011;54(4):1032-41.
60. Sica V. Autologous bone marrow cell treatment in peripheral atherosclerosis. www.clinicaltrials.gov/ct2/show/NCT00306085?term=stem+cell+AND+limb+ischaemia&rank=11 (accessed November 2009).
61. Smadja DM, Duong-van-Huyen JP, Dal Cortivo L, Blanchard A, Bruneval P, Emmerich J, et al. Early endothelial progenitor cells in bone marrow are a biomarker of cell therapy success in patients with critical limb ischemia. Cytotherapy 2012;14(2):232-9.
62. Subramaniyam V, Reddy U, Harris W, Sutcliffe D. Safety and efficacy of bone marrow mobilization with granulocyte-macrophage colony stimulating factor in patients with intermittent claudication. Program and Abstracts of the American College of Cardiology 55th Annual Scientific Session. 2006.
63. Subramaniyam V, Waller EK, Murrow JR, Manatunga A, Lonial S, Kasirajan K, et al. Bone marrow mobilization with granulocyte macrophage colony-stimulating factor improves endothelial dysfunction and exercise capacity in patients with peripheral arterial disease. American Heart Journal 2009;158(1):53-60.
64. Szabo GV, Kovesd Z, Cserepes J, Daroczy J, Belkin M, Acsady G. Peripheral blood-derived autologous stem cell therapy for the treatment of patients with late-stage peripheral artery disease-results of the short- and long-term follow-up. Cytotherapy 2013;15(10):1245-52.
65. Takagi G, Miyamoto M, Tara S, Takagi I, Takano H, Yasutake M, et al. Controlled-release basic fibroblast growth factor for peripheral artery disease: comparison with autologous bone marrow-derived stem cell transfer. Tissue Engineering 2011;17(21-22):2787-94.
66. 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. American Heart Journal 2008;156(5):1010-8.
67. 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(9331):427-35.
68. Van Huyen JP, Smadja DM, Bruneval P, Gaussem P, Dal-Cortivo L, Julia P, et al. Bone marrow-derived mononuclear cell therapy induces distal angiogenesis after local injection in critical leg ischemia. Modern Pathology 2008;21(7):837-46.
69. 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. Journal of Cardiovascular Surgery 2008;49(1):51-8.
70. Walter D, Krankenberg H, Balzer J, Kalka C, Baumgartner I, Schluter M. Intra-arterial administration of bone marrow mononuclear cells in patients with critical limb ischemia - a randomized-start, placebo-controlled pilot trial (PROVASA). Vasa 2010;39:37.
71. Walter DH, Krankenberg H, Balzer JO, Kalka C, Baumgartner I, Schlüter M, et al. Intraarterial administration of bone marrow mononuclear cells in patients with critical limb ischemia a randomized-start, placebo-controlled pilot trial (PROVASA). Circulation: Cardiovascular Interventions 2011;4(1):26-37.
72. Wen J. Autologous peripheral blood mononuclear cells transplantation in treatment of 30 cases of critical limb ischemia: 3-year safety follow-up. Journal of Clinical Rehabilitative Tissue Engineering Research 2010;14:8526-30.
73. Zafarghandi MRR, Fazel AP, Baharvand H. Safety and efficacy of granulocytecolony-stimulating factor administration following autologous intramuscular implantation of bone marrow mononuclear cells: a randomized controlled trial in patients with advanced lower limb ischemia. Cytotherapy 2010;12:783-91.
74. Zhang H-F, Zhao Z-G, Zhang C-L, Yuan H-J, Wang Y-F. Autologous transplantation of bone marrow stem cells versus peripheral blood stem cells for treatment of diabetic lower limb ischemia: a comparative study in 52 cases [Chinese]. Journal of Clinical Rehabilitative Tissue Engineering Research 2009;13(6):1109-12.
75. Zhang HFZ. Endovascular transplantation of autologous bone marrow stem cells for the treatment of diabetic lower limb arterial occlusion. Journal of Clinical Rehabilitative Tissue Engineering Research 2010;14:6040-3.
76. Zhao ZG, Yuan HJ, Zhang HF, Zhang CL, Wang YF, Ma SP, et al. Combined transplantation of autologous peripheral blood and bone narrow stem cells for the treatment of diabetic lower limb ischaemia: Randomized controlled trial [Chinese]. Journal of Clinical Rehabilitative Tissue Engineering Research 2008;12(8):1464-6.
77. GRADE Working Group. Grading quality of evidence and strength of recommendations. BMJ 2004;328:1490-4.
78. 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(10):1215-8.
79. Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
80. Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, et al. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and theACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation 2006;113(11):e463-654.
81. Huang PP, Li SZ, Han MZ, Xiao ZJ, Yang RC, Qiu LG, et al. Autologous transplantation of peripheral blood stem cells as effective therapeutic approach for severe arteriosclerosis obliterans of lower extremities. Thrombosis and Haemostasis 2004;91(3):606-9.
82. Huang P, Li S, Han M, Xiao Z, Yang R, Han ZC. Autologous transplantation of granulocyte colony-stimulating factor-mobilized peripheral blood mononuclear cells improves critical limb ischemia in diabetes. Diabetes Care 2005;28(9):2155-60.
83. Leibovich SJ, Polverini PJ, Shepard HM, Wiseman DM, Shively V, Nuseir N. Macrophage-induced angiogenesis is mediated by tumour necrosis factor-alpha. Nature 1987;329(6140):630-2.
84. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FGR, et al. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Journal of Vascular Surgery 2007;45 Suppl 1:5-67.
85. Prockop DJ. Marrow stromal cells as stem cells for nonhematopoietic tissues. Science 1997;276(5309):71-4.
86. Shintani S, Murohara T, Ikeda H. Augmentation of postnatal neovascularization with autologous bone marrow transplantation. Circulation 2001;103(6):897-903.
87. Tateishi-Yuyama E, Matsubara H, Murohara T, Ikeda U, Shintani S, Masaki H, et al. Therapeutic angiogenesis for patients with limb ischemia by autologous transplantation of bone-marrow cells: a pilot study and a randomized controlled trial. Lancet 2002;360(9331):427-35.
88. Moazzami K, Majdzadeh R, Nedjat S. Local intramuscular transplantation of autologous mononuclear cells for critical lower limb ischaemia. Cochrane Database of Systematic Reviews 2011, Issue 12. [DOI: 10.1002/14651858.CD008347.pub2]