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)
MYSTAR study compared timing of delivery for combined intramyocardial and intracoronary routes
Both types of catheters were used in this study, with their respective imaging modality for navigation