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. Author manuscript; available in PMC: 2013 Jan 1.
Published in final edited form as: Eur J Nucl Med Mol Imaging. 2011 Sep 8;39(1):165–181. doi: 10.1007/s00259-011-1925-7

Table 1.

Clinical studies using image navigation for transendocardial cell delivery

Study authors
(study name)
Catheter Disease Design No. of patients Cell type
(A) Electromechanical mapping
  Krause et al. [39] MyoStar™ Acute MI Non-controlled 20 BM MNC
  Gyöngyösi et al. [155] (MYSTARa) MyoStar™ Acute and chronic MI Randomised time comparison 30 early, 30 late BM MNC
  Briguori et al. [156] MyoStar™ Chronic IHD Non-controlled 10 BM MNC
  Beeres et al. [157] MyoStar™ Chronic IHD Non-controlled 25 BM MNC
  Fuchs et al. [158] MyoStar™ Chronic IHD Non-controlled 27 BMC
  Losordo et al. [11] MyoStar™ Chronic IHD RDBPCT dose-escalation 18 Rx, 6 placebo G-CSF + CD34+ cells
  Tse et al. [159] (PROTECT-CAD) MyoStar™ Chronic IHD RBPCT dose-comparison 19 Rx, 9 placebo BM MNC
  van Ramshorst et al. [160] MyoStar™ Chronic IHD RDBPCT 25 Rx, 24 placebo BM MNC
  Perin et al. [38] MyoStar™ Ischaemic CMP NRCT 11 Rx, 9 control BM MNC
  Dib et al. [161] (CAuSMIC) MyoStar™ Chronic MI/ischaemic CMP RPCT dose-escalation 12 Rx, 11 placebo SkM
(B) X-ray fluoroscopy
  Ince et al. [29] MyoCath™ Chronic MI/ischaemic CMP Case-controlled 6 Rx, 6 control SkM
  Smits et al. [30]b MyoStar™/MyoCath™ Chronic MI/ischaemic CMP Non-controlled 15 SkM
  de la Fuente et al. [31] Helix™ Chronic MI/ischaemic CMP Non-controlled 10 BM MNC
  Duckers et al. [32] (SEISMIC) MyoCath™ Ischaemic CMP RCT 26 Rx, 14 control SkM

BM bone marrow, BMC bone marrow cells, CMP cardiomyopathy, G-CSF granulocyte colony-stimulating factor, IHD ischaemic heart disease, MI myocardial infarct, MNC mononuclear cells, (N)RCT (non-)randomised controlled trial, R(DB)PCT randomised (double-blinded) placebo-controlled trial, Rx cell treatment, SkM skeletal myoblasts

MyoCath™ (Bioheart Inc., Sunrise, FL, USA) and Helix™ (Biocardia, Inc., South San Francisco, CA, USA)

a

MYSTAR study compared timing of delivery for combined intramyocardial and intracoronary routes

b

Both types of catheters were used in this study, with their respective imaging modality for navigation