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| Study name | Trial | Phase | Results | Trial identifier | Citation |
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Comparison of allogeneic vs autologous bone marrow-derived mesenchymal stem cells delivered by transendocardial injection in patients with ischemic cardiomyopathy: the POSEIDON randomized trial
(POSEIDON) | To test whether allogeneic MSCs are as safe and effective as autologous
MSCs in patients with left ventricular (LV) dysfunction due to ICM | Phase 1/2 randomized | Patients with ICM that received transendocardial injection of allogeneic and autologous MSCs demonstrated favorable outcomes on patient functional capacity, quality of life, and ventricular remodeling without adverse effects | NCT01087996 | [32] |
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Cardiopoietic stem cell therapy in heart failure: the C-CURE (cardiopoietic stem cell therapy in heart failure) multicenter randomized trial with lineage-specified biologics
(C-CURE) | To evaluate the feasibility and safety of autologous bone marrow-derived and cardiogenically oriented mesenchymal stem cell therapy and to probe for signs of efficacy in patients with chronic heart failure | Prospective, multicenter, randomized trial | Cardiopoietic stem cell therapy was found feasible and safe with signs of benefit in chronic heart failure, meriting definitive clinical evaluation | NCT00810238 | [67] |
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Transendocardial mesenchymal stem cells and mononuclear bone marrow cells for ischemic cardiomyopathy: the TAC-HFT randomized trial
(TAC-HFT) | To demonstrate the safety of transendocardial stem cell injection with autologous mesenchymal stem cells (MSCs) and bone marrow mononuclear cells in patients with ischemic cardiomyopathy | Phase 1 and 2 randomized, blinded, placebo-controlledstudy | Transendocardial stem cell injection with MSCs or bone marrow mononuclear cells appeared to be safe for patients with chronic ischemic cardiomyopathy and LV dysfunction | NCT00768066 | [73] |
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Rationale and design of the first randomized, double-blind, placebo-controlled trial of intramyocardial injection of autologous bone-marrow derived mesenchymal stromal cells in chronic ischemic heart failure (MSC-HF Trial)
(MSC-HF) | To investigate the role of MSCs in patients with chronic ischemia utilizing intramyocardial injections in an ischemic viable region of the myocardium using the electromechanical NOGA-XP system | Phase 2, single-center, double-blind, randomized, placebo-controlledtrial | Intramyocardial injection of bone marrow-derived MSCs decreased LVEV, improved LV EF, increased stroke volume, and increased myocardial mass significantly compared to placebo | NCT00644410 | [76] |
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A randomized study of transendocardial injection of autologous bone marrow mononuclear cells and cell function analysis in ischemic heart failure (FOCUS-HF)
(FOCUS-HF) | To evaluate the safety and efficacy of the transendocardial delivery of autologous bone marrow mononuclear cells in patients with chronic HF | Phase 1, single-blind trial | Autologous bone marrow mononuclear cell therapy is safe and improves symptoms, quality of life, and possibly perfusion in patients with chronic HF | NCT00203203 | [69] |
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| RIMECARD | To assess the safety and efficacy of umbilical cord-derived MSCs in compensated dilated CM | Phase 1/2 | Completed | NCT01739777 | |
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TEVA CEP-41750
(DREAM-HF) | To evaluate efficacy and safety of allogeneic mesenchymal precursor cells (CEP-41750) for the treatment of chronic HF | Phase 3 | Ongoing | NCT02032004 | |
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Combination of mesenchymal and C-kit+ cardiac stem cells as regenerative therapy for heart failure
(CONCERT-HF) | To evaluate the feasibility, safety, and effect of MSCs CSCs, and combination in heart failure of ischemic etiology, administered by transendocardial injection in ischemic cardiomyopathy | Phase 2 randomized, placebo-controlledclinical trial | Ongoing | NCT02501811 | |
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| Intravenous administration of allogeneic bone marrow-derived multipotent mesenchymal stromal cells (MSCs) in patients with recent onset anthracycline-associated cardiomyopathy | To learn if adding mesenchymal stem cells (MSCs) to standard-of-care drugs can help control heart failure that may have been caused by anthracyclines | Phase 1 | Ongoing | NCT02408432 | |
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| Intravenous allogeneic mesenchymal stem cells for nonischemic cardiomyopathy: safety and efficacy results of a phase II-A randomized trial | To assess the safety and preliminary efficacy of intravenously administered ischemia-tolerant MSCs (itMSCs) in patients with nonischemic cardiomyopathy | Phase 2 single-blind, placebo-controlled, crossover, randomized | In patients with nonischemic cardiomyopathy, ischemia-tolerant MSC therapy was safe, caused immunomodulatory effects, and was associated with improvements in health status and functional capacity | NCT02467387 | [72] |
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A randomized clinical trial of adipose-derived stem & regenerative cells in the treatment of patients with non revascularizable ischemic myocardium – the PRECISE trial
(PRECISE) | To establish safety and feasibility of utilizing adipose derived stem & regenerative cells (ADRCs) in patients who have areas of myocardium that are not revascularizable and have demonstrated reversible ischemia | Phase 1, randomized, double-blind trial | Isolation and transendocardial injection of autologous ADRCs in no-option patients were safe and feasible | NCT00426868 | |
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| Allogeneic adipose tissue-derived stromal/stem cell therapy in patients with ischemic heart disease and heart failure - a safety study | To perform a small clinical safety trial in heart failure patients with allogeneic adipose tissue-derived mesenchymal stem cells | Phase 1 | Ongoing | NCT02387723
2015-001560-19 | |
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Stem cell therapy in ischemic non-treatable cardiac disease - SCIENCE A European Multi-Centre Trial
(SCIENCE) | To investigate the efficacy of direct intramyocardial injection allogeneic adipose-derived stem cells in patients with reduced left ventricular ejection fraction (EF) (≤45%) and heart failure | Phase 2, double-blind, placebo-controlledtrial | Ongoing | NCT02673164
2015-002929-19 | |
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Efficacy and safety of bone marrow-derived mesenchymal cardiopoietic cells (C3BS-CQR-1) for the treatment of chronic advanced ischemic heart failure
(CHART-1) | To evaluate the safety and efficacy of C3BS-CQR-1 by comparing the overall response to standard of care and C3BS-CQR-1 relative to standard of care and a sham procedure | Phase 3, randomized, double-blind trial | Ongoing | NCT01768702 | |
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