Skip to main content
. 2022 Jan 26;14(1):1–40. doi: 10.4252/wjsc.v14.i1.1

Table 2.

Completed clinical trials reporting on the use of cardiac derived stem cells in cardiovascular disorders

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.