Challenges enrolling patients with acute ischemic stroke into cell therapy trials

Stem Cells and Development

Volumn 22, Issue 1, 2013, Pages 27-30

  Vahidy, Farhaan S ^a   Alderman, Susan ^a   Savitz, Sean I ^a  

^a UNIVERSITY OF TEXAS MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HEPARIN; LOW MOLECULAR WEIGHT HEPARIN; TISSUE PLASMINOGEN ACTIVATOR; WARFARIN;

ANTICOAGULATION; ARTICLE; AUTOLOGOUS BONE MARROW DERIVED MONONUCLEAR CELL TRANSPLANTATION; AUTOLOGOUS STEM CELL TRANSPLANTATION; BLEEDING; BLOOD CLOT LYSIS; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; CELL THERAPY; CLINICAL TRIAL (TOPIC); CONSCIOUS SEDATION; CONVALESCENCE; CORONARY ARTERY RECANALIZATION; DEEP VEIN THROMBOSIS; DISEASE SEVERITY; FEASIBILITY STUDY; HUMAN; PATIENT SAFETY; PRIORITY JOURNAL; STROKE PATIENT; TREATMENT PLANNING;

ANTICOAGULANTS; BONE MARROW CELLS; CEREBRAL INFARCTION; CLINICAL TRIALS, PHASE I AS TOPIC; CONSCIOUS SEDATION; MONOCYTES; PATIENT SELECTION; PRACTICE GUIDELINES AS TOPIC; TISSUE PLASMINOGEN ACTIVATOR; TRANSPLANTATION, AUTOLOGOUS;

EID: 84871418175     PISSN: 15473287     EISSN: 15578534     Source Type: Journal    
DOI: 10.1089/scd.2012.0404     Document Type: Article

References (32)

1. Bliss TM, RH Andres and GK Steinberg. (2010). Optimizing the success of cell transplantation therapy for stroke. Neurobiol Dis 37:275-283.
2. Savitz SI, V Misra, M Kasam, H Juneja, CS Cox, Jr., S Alderman, I Aisiku, S Kar, A Gee and JC Grotta. (2011). Intravenous autologous bone marrow mononuclear cells for ischemic stroke. Ann Neurol 70:59-69.
3. Baker AH, V Sica, LM Work, S Williams-Ignarro, F de Nigris, LO Lerman, A Casamassimi, A Lanza, C Schiano, et al. (2007). Brain protection using autologous bone marrow cell, metalloproteinase inhibitors, and metabolic treatment in cerebral ischemia. Proc Natl Acad Sci U S A 104:3597-3602. (Pubitemid 46364204)
4. Giraldi-Guimaraes A, M Rezende-Lima, FP Bruno and R Mendez-Otero. (2009). Treatment with bone marrow mononuclear cells induces functional recovery and decreases neurodegeneration after sensorimotor cortical ischemia in rats. Brain Res 1266:108-120.
5. Yang B, R Strong, S Sharma, M Brenneman, K Mallikarjunarao, X Xi, JC Grotta, J Aronowski and SI Savitz. (2011). Therapeutic time window and dose response of autologous bone marrow mononuclear cells for ischemic stroke. J Neurosci Res 89:833-839.
6. Iihoshi S, O Honmou, K Houkin, K Hashi and JD Kocsis. (2004). A therapeutic window for intravenous administration of autologous bone marrow after cerebral ischemia in adult rats. Brain Res 1007:1-9. (Pubitemid 38520167)
7. Moniche F, A Gonzalez, JR Gonzalez-Marcos, M Carmona, P Pinero, I Espigado, D Garcia-Solis, A Cayuela, J Montaner, et al. (2012). Intra-arterial bone marrow mononuclear cells in ischemic stroke: a pilot clinical trial. Stroke 43:2242-2244.
8. Friedrich MA, MP Martins, MD Araujo, C Klamt, L Vedolin, B Garicochea, EF Raupp, J Sartori El Ammar, DC Machado, et al. (2012). Intra-arterial infusion of autologous bone marrow mononuclear cells in patients with moderate to severe middle cerebral artery acute ischemic stroke. Cell Transplant 21 Suppl 1:S13-S21.
9. Thanvi B, S Treadwell and T Robinson. (2008). Early neurological deterioration in acute ischaemic stroke: predictors, mechanisms and management. Postgrad Med J 84: 412-417.
10. Roquer J, A Rodriguez-Campello, M Gomis, J Jimenez- Conde, E Cuadrado-Godia, R Vivanco, E Giralt, M Sepulveda, C Pont-Sunyer, G Cucurella and A Ois. (2008). Acute stroke unit care and early neurological deterioration in ischemic stroke. J Neurol 255:1012-1017.
11. Ben Assayag E, AD Korczyn, N Giladi, U Goldbourt, AS Berliner, S Shenhar-Tsarfaty, E Kliper, H Hallevi, L Shopin, et al. (2012). Predictors for poststroke outcomes: the Tel Aviv Brain Acute Stroke Cohort (TABASCO) study protocol. Int J Stroke 7:341-347.
12. Coutts SB, MD Hill, M Eliasziw, K Fischer and AM Demchuk. (2011). Final 2 year results of the vascular imaging of acute stroke for identifying predictors of clinical outcome and recurrent ischemic eveNts (VISION) study. BMC Cardiovasc Disord 11:18.
13. Hofmeijer J, LJ Kappelle, A Algra, GJ Amelink, J van Gijn and HB van der Worp. (2009). Surgical decompression for space-occupying cerebral infarction (the Hemicraniectomy After Middle Cerebral Artery infarction with Life-threatening Edema Trial [HAMLET]): a multicentre, open, randomized trial. Lancet Neurol 8:326-333.
14. Del Zoppo GJ, JL Saver, EC Jauch and HP Adams, Jr. (2009). Expansion of the time window for treatment of acute ischemic stroke with intravenous tissue plasminogen activator: a science advisory from the American Heart Association/American Stroke Association. Stroke 40:2945- 2948.
15. Wardlaw JM, V Murray, E Berge and GJ Del Zoppo. (2009). Thrombolysis for acute ischaemic stroke. Cochrane Database Syst Rev CD000213.
16. (1995). Tissue plasminogen activator for acute ischemic stroke. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. N Engl J Med 333:1581- 1587.
17. Hacke W, M Kaste, E Bluhmki, M Brozman, A Davalos, D Guidetti, V Larrue, KR Lees, Z Medeghri, et al. (2008). Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med 359:1317-1329.
18. Wahlgren N, N Ahmed, A Davalos, GA Ford, M Grond, W Hacke, MG Hennerici, M Kaste, S Kuelkens, et al. (2007). Thrombolysis with alteplase for acute ischaemic stroke in the Safe Implementation of Thrombolysis in Stroke- Monitoring Study (SITS-MOST): an observational study. Lancet 369:275-282. (Pubitemid 46138121)
19. Kirshner HS. (2012). Antiplatelet and anticoagulation strategies in the prevention and treatment of ischaemic stroke. Curr Pharm Des 18:5261-5272.
20. Sacco RL, R Adams, G Albers, MJ Alberts, O Benavente, K Furie, LB Goldstein, P Gorelick, J Halperin, et al. (2006). Guidelines for prevention of stroke in patients with ischemic stroke or transient ischemic attack: a statement for healthcare professionals from the American Heart Association/American Stroke Association Council on Stroke: co-sponsored by the Council on Cardiovascular Radiology and Intervention: the American Academy of Neurology affirms the value of this guideline. Stroke 37:577-617. (Pubitemid 43732031)
21. Furie KL, SE Kasner, RJ Adams, GW Albers, RL Bush, SC Fagan, JL Halperin, SC Johnston, I Katzan, et al. (2011). Guidelines for the prevention of stroke in patients with stroke or transient ischemic attack: a guideline for healthcare professionals from the american Heart Association/ American Stroke Association. Stroke 42:227-276.
22. Adams RJ, G Albers, MJ Alberts, O Benavente, K Furie, LB Goldstein, P Gorelick, J Halperin, R Harbaugh, et al. (2008). Update to the AHA/ASA recommendations for the prevention of stroke in patients with stroke and transient ischemic attack. Stroke 39:1647-1652.
23. Palomares SM and MJ Cipolla. (2011). Vascular protection following cerebral ischemia and reperfusion. J Neurol Neurophysiol 2011:S1-004.
24. Castilla-Guerra L and MD Fernandez-Moreno. (2012). Update on the management of hypertension for secondary stroke prevention. Eur Neurol 68:1-7.
25. Taylor DM, A Bell, A Holdgate, C MacBean, T Huynh, O Thom, M Augello, R Millar, R Day, et al. (2011). Risk factors for sedation-related events during procedural sedation in the emergency department. Emerg Med Australas 23:466-473.
26. Brott TG, RW Hobson, 2nd, G Howard, GS Roubin, WM Clark, W Brooks, A Mackey, MD Hill, PP Leimgruber, et al. (2010). Stenting versus endarterectomy for treatment of carotid-artery stenosis. N Engl J Med 363:11-23.
27. Ringleb PA, J Allenberg, H Bruckmann, HH Eckstein, G Fraedrich, M Hartmann, M Hennerici, O Jansen, G Klein, et al. (2006). 30 day results from the SPACE trial of stentprotected angioplasty versus carotid endarterectomy in symptomatic patients: a randomised non-inferiority trial. Lancet 368:1239-1247.
28. Mas JL, G Chatellier, B Beyssen, A Branchereau, T Moulin, JP Becquemin, V Larrue, M Lievre, D Leys, et al. (2006). Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med 355:1660-1671. (Pubitemid 44583956)
29. Ederle J, J Dobson, RL Featherstone, LH Bonati, HB van der Worp, GJ de Borst, TH Lo, P Gaines, PJ Dorman, et al. (2010). Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomized controlled trial. Lancet 375:985-997.
30. Lou M, A Safdar, M Mehdiratta, S Kumar, G Schlaug, L Caplan, D Searls and M Selim. (2008). The HAT Score: a simple grading scale for predicting hemorrhage after thrombolysis. Neurology 71:1417-1423.
31. Strbian D, S Engelter, P Michel, A Meretoja, L Sekoranja, FJ Ahlhelm, S Mustanoja, I Kuzmanovic, T Sairanen, et al. (2012). Symptomatic intracranial hemorrhage after stroke thrombolysis: the SEDAN score. Ann Neurol 71:634-641.
32. Furlani D, M Ugurlucan, L Ong, K Bieback, E Pittermann, I Westien, W Wang, C Yerebakan, W Li, et al. (2009). Is the intravascular administration of mesenchymal stem cells safe? Mesenchymal stem cells and intravital microscopy. Microvasc Res 77:370-376.