Table 2.
Study name, NCT Number
|
Start year
|
Study phase
|
Cardio-vascular disease
|
Patients number
|
Type of cardiac stem cells/origin
|
Route of delivery /count of cells
|
Timing of cell delivery
|
Follow up times
|
Imagingtechniques
|
Outcomes
|
Ref.
|
CADUCEUS, 00893360 | 2009 | 1 | IHD | 17 | Autologous CDCs/endomyocardial biopsies | IC/12.5-25 × 106 | 1.5-3 m post STEMI | 6 mo | MRI | Significant reduction in infarct size | [221] |
Significant growth in viable mass global LVEF remains unchanged LVEF and volumes. | |||||||||||
ALLSTAR, 01458405 | 2017 | I/II | IHD | 90 | Allogenic CDCs/endomyocardial biopsies | IC/25 × 106 | < 5 d post MI | 12 mo | MRI | No effect on scar sizeAttenuation of post infarct cardiac remodeling | [222] |
Improvement in LV end diastolic volume | |||||||||||
ALCADIA, 00981006 | 2010 | I | CHFIHDVD | 6 | Autologous hCSCs/endomyocardial biopsies + bFGF on gelatin hydrogel sheet | IM/0.5 × 106 /kg and 200 µg of bFGF | At CABG | 12 mo | Not mentioned | Decreased scar size | [229] |
ESCORT, 020579000 | 2013 | I | IHD | 6 | ESCs-derived ISL1+ CSCs | Epicardial patch 5-10 × 106 CSCs embedded in a fibrin patch | At CABG | 18 mo | CT | Symptomatically improved patients with an increased systolic motion of the cell- treated segments. | [223] |
PET scan | |||||||||||
The protocol generated a highly purified population of cardiovascular progenitors. | |||||||||||
Echo | |||||||||||
One patient died of heart failure after 22 mo | |||||||||||
CAREMI, 02439398. | 2014 | I/II | AMI | 55 | Allogeneic hCSCs/right atrial appendage | IC/35 × 106 cells | 5 to 7 d after successful reperfusion of AMI by PCI or 8 d from symptoms onset | 1 wk, 1, 2, 3, 4, 5, 6, 9 and 12 mo | MRI | Allogeneic CSCs intracoronary infusion early after AMI is safe and anticipates reasonable efficacy outcomes | [227] |
ECG | |||||||||||
CONSERT-HF, 02501811. | 2015 | II | HF | 125 | Autologous c-KIT+ CPCs + MSCs/right ventricular endocardial biopsy + Bone marrow aspiration | Trans endocardial/150 × 106 MSCs and 5 × 106 CPCs | 14 wk after cell harvest | 6 and 12 mo | MRI | Increased LVEF | [230] |
Treadmill | |||||||||||
Decrease in infarct size with LV end systolic volume reduction. | |||||||||||
Questionnaire | |||||||||||
Strong safety profile | |||||||||||
HOPE, 02485938 | 2015 | I\II | CM secondary to DMD | 25 | Allogeneic CDCs | IC/75 × 106 | Not specified | 12 mo | MRI | Significant scar reduction improvement in inferior wall systolic thickening compared to the usual care group. | [228] |
Questionnaire | |||||||||||
CDCs are generally safe and well-tolerated | |||||||||||
DYNAMIC, 02293603 | 2014 | I | Idiopathic dilated CM | 42 | Allogeneic CDC/not specified | IC/Stepwise dose escalation | Not specified | 6, 12 mo | ECG | Not published | _ |
Cardiac enzymes | |||||||||||
TICAP, 01273857 | 2011 | I | HLHS | 7 | Autologous CDCs/right atrial appendage | IC/0.3 × 106 cells/kg | 1 m after cardiac surgery | 36 mo | Echo | Safety of the procedure | [233] |
Increased right ventricle ejection fraction | |||||||||||
Improved somatic growth | |||||||||||
Reduced heart failure status | |||||||||||
Perseus, 01829750 | 2013 | II | HLHS | 34 | Autologous CDCs/not specified | IC/0.3 × 106 cells/kg | 4 to 9 wk after surgery | 3 and 12 mo follow-up | EchoMRIQuestionnaire | Significant improve of ventricular function | [231] |
Improved somatic growth, and quality of life | |||||||||||
Reduced heart failure status and cardiac fibrosis compared with baseline |
AMI: Acute myocardial infarction; bFGF: Basic fibroblast growth factor; CABG: Coronary artery by bass graft; CHF: Congestive heart failure; CM: Cardiomyopathy; CSC: Cardiac stem cell; DMD: Duchenne muscle dystrophy; hCSC: Human-derived cardiac stem cell; HLHS: Hypoplastic left heart syndrome; IC: Intracoronary; IHD: Ischemic heart disease; IHF: Ischemic heart failure; IM: Intramyocardial; MRI: Magnetic resonance imaging; NCT: National clinical trial; PCI: Percutaneous infusion; STEMI: ST segment elevation after MI; VD: Ventricular dysfunction.