Intramuscular transplantation of G-CSF-mobilized CD34+ cells in patients with critical limb ischemia: A phase I/IIa, multicenter, single-blinded, dose-escalation clinical trial

Stem Cells

Volumn 27, Issue 11, 2009, Pages 2857-2864

  Kawamoto, Atsuhiko ^a   Katayama, Minako ^a   Handa, Nobuhiro ^b   Kinoshita, Makoto ^a,b   Takano, Haruna ^a   Horii, Miki ^a   Sadamoto, Kazuyo ^a   Yokoyama, Ayumi ^a   Yamanaka, Takeharu ^c   Onodera, Rie ^c   Kuroda, Akiko ^a   Baba, Rie ^a   Kaneko, Yuichiro ^a   Tsukie, Tomio ^b   Kurimoto, Yasuo ^b   Okada, Yukikatsu ^b   Kihara, Yasuki ^b   Morioka, Shigefumi ^b   Fukushima, Masanori ^c   Asahara, Takayuki ^a,d  

^a INSTITUTE OF BIOMEDICAL RESEARCH AND INNOVATION   (Japan)

^b KOBE CITY MEDICAL CENTER GENERAL HOSPITAL   (Japan)

^c Translational Research Informatics Center   (Japan)

^d TOKAI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

Author keywords

Adult stem cells; Angiogenesis; CD34; Cellular therapy; Clinical trials

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ANTITHROMBOCYTIC AGENT; AS TEC204; C REACTIVE PROTEIN; GRANULOCYTE COLONY STIMULATING FACTOR; LACTATE DEHYDROGENASE; UNCLASSIFIED DRUG;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; APHERESIS; ARTICLE; BONE PAIN; BUERGER DISEASE; CARDIOVASCULAR PARAMETERS; CD34 SELECTION; CELL ISOLATION; CELL SELECTION; CELL THERAPY; CELL TRANSPLANTATION; CLINICAL ARTICLE; CLINICAL STUDY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYSTITIS; DOSE RESPONSE; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG MEGADOSE; DRUG SAFETY; ENDOTHELIUM CELL; FACES PAIN SCALE; FEMALE; FEVER; FOLLOW UP; HEADACHE; HEARING IMPAIRMENT; HEMATOPOIETIC STEM CELL; HUMAN; LACTATE DEHYDROGENASE BLOOD LEVEL; LEG AMPUTATION; LEG ISCHEMIA; LEG ULCER; LEUKAPHERESIS; LEUKOCYTE COUNT; LOW BACK PAIN; LOW DRUG DOSE; LUNG CONGESTION; MAGNETISM; MALE; MULTICENTER STUDY; OBSERVATION; PAIN; PARAMETER; PARESTHESIA; PERIPHERAL OCCLUSIVE ARTERY DISEASE; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PROSPECTIVE STUDY; PSORIASIS VULGARIS; RANDOMIZED CONTROLLED TRIAL; SAFETY; SCORING SYSTEM; SIDE EFFECT; SINGLE BLIND PROCEDURE; SYNCOPE; TETANY; THROMBOCYTOPENIA; TOE BRACHIAL PRESSURE INDEX; TRANSCUTANEOUS OXYGEN MONITORING; TREATMENT RESPONSE; TRICHOMONIASIS; URIC ACID BLOOD LEVEL; WALKING;

ADULT; AGED; AGED, 80 AND OVER; ANTIGENS, CD34; FEMALE; GRANULOCYTE COLONY-STIMULATING FACTOR; HUMANS; INJECTIONS, INTRAMUSCULAR; ISCHEMIA; LEG; MALE; STEM CELL TRANSPLANTATION; STEM CELLS; TISSUE THERAPY; TRANSPLANTATION, AUTOLOGOUS; TREATMENT OUTCOME;

EID: 73149090351     PISSN: 10665099     EISSN: None     Source Type: Journal    
DOI: 10.1002/stem.207     Document Type: Article

References (22)

1. Hirsch AT, Haskal ZJ, Hertzer NR et al. ACC/AHA 2005 guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): Executive summary 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 the ACC/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. J Am Coll Cardiol 2006;47:1239-1312.
2. Norgren L, Hiatt WR, Dormandy JA et al. Inter-Society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg 2007;45(suppl S):S5-S67. (Pubitemid 46151680)
3. Asahara T, Murohara T, Sullivan A et al. Isolation of putative progenitor endothelial cells for angiogenesis. Science 1997;275:964-967. (Pubitemid 27087709)
4. Asahara T, Masuda H, Takahashi T et al. Bone marrow origin of endothelial progenitor cells responsible for postnatal vasculogenesis in physiological and pathological neovascularization. Circ Res 1999;85:221-228. (Pubitemid 29377293)
5. + endothelial progenitor cell subpopulation with potent vasoregenerative capacities. Circ Res 2006;98:e20-e25.
6. Takahashi T, Kalka C, Masuda H et al. Ischemia- and cytokine-induced mobilization of bone marrow-derived endothelial progenitor cells for neovascularization. Nat Med 1999;5:434-438. (Pubitemid 29180584)
7. Masuda H, Kalka C, Takahashi T et al. Estrogen-mediated endothelial progenitor cell biology and kinetics for physiological postnatal vasculogenesis. Circ Res 2007;101:598-606.
8. Kalka C, Masuda H, Takahashi T et al. Transplantation of ex vivo expanded endothelial progenitor cells for therapeutic neovascularization. Proc Natl Acad Sci U S A 2000;97:3422-3427. (Pubitemid 30183318)
9. Kawamoto A, Gwon HC, Iwaguro H et al. Therapeutic potential of ex vivo expanded endothelial progenitor cells for myocardial ischemia. Circulation 2001;103:634-637. (Pubitemid 32144189)
10. + cells after stroke enhances neurogenesis via angiogenesis in a mouse model. J Clin Invest 2004;114:330-338.
11. Powell RJ, Simons M, Mendelsohn FO et al. Results of a double-blind, placebo-controlled study to assess the safety of intramuscular injection of hepatocyte growth factor plasmid to improve limb perfusion in patients with critical limb ischemia. Circulation 2008;118:58-65.
12. Baumgartner I, Pieczek A, Manor O et al. Constitutive expression of phVEGF165 after intramuscular gene transfer promotes collateral vessel development in patients with critical limb ischemia. Circulation 1998;97:1114-1123. (Pubitemid 28152883)
13. Tateishi-Yuyama E, Matsubara H, Murohara T 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. (Pubitemid 34884192)
14. Tateno K, Minamino T, Toko H et al. Critical roles of muscle-secreted angiogenic factors in therapeutic neovascularization. Circ Res 2006;98:1194-1202.
15. Kawamoto A, Murayama T, Kusano K et al. Synergistic effect of bone marrow mobilization and vascular endothelial growth factor-2 gene therapy in myocardial ischemia. Circulation 2004;110:1398-1405.
16. Zohlnhofer D, Ott I, Mehilli J et al. Stem cell mobilization by granulocyte colony-stimulating factor in patients with acute myocardial infarction: A randomized controlled trial. JAMA 2006;295:1003-1010.
17. Ripa RS, Jorgensen E, Wang Y et al. Stem cell mobilization induced by subcutaneous granulocyte-colony stimulating factor to improve cardiac regeneration after acute ST-elevation myocardial infarction: Result of the double-blind, randomized, placebo-controlled stem cells in myocardial infarction (STEMMI) trial. Circulation 2006;113:1983-1992.
18. Iwasaki H, Kawamoto A, Ishikawa M et al. Dose-dependent contribution of CD34-positive cell transplantation to concurrent vasculogenesis and cardiomyogenesis for functional regenerative recovery after myocardial infarction. Circulation 2006;113:1311-1325. (Pubitemid 43739453)
19. + stem cells for intractable angina: A phase I/IIa double-blind, randomized controlled trial. Circulation 2007;115:3165-3172.
20. Vasa M, Fichtlscherer S, Aicher A et al. Number and migratory activity of circulating endothelial progenitor cells inversely correlate with risk factors for coronary artery disease. Circ Res 2001;89:E1-E7.
21. Tepper OM, Galiano RD, Capla JM et al. Human endothelial progenitor cells from type II diabetics exhibit impaired proliferation, adhesion, and incorporation into vascular structures. Circulation 2002;106:2781-2786.
22. Miyamoto K, Nishigami K, Nagaya N et al. Unblinded pilot study of autologous transplantation of bone marrow mononuclear cells in patients with thromboangiitis obliterans. Circulation 2006;114:2679-2684. (Pubitemid 44967352)