Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia
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About
Mesenchymal stem cells from the bone marrow can be stimulated to differentiate into endothelial cells and participate in the development of new blood vessels in ischemic tissue.
The aim of the study is in a phase I/II safety and efficacy study to evaluate the clinical effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial ischemia.
Full description
Mesenchymal stem cells from the bone marrow can be stimulated to differentiate into endothelial cells and participate in the development of new blood vessels in ischemic tissue.
The aim of the study is in a phase I/II safety and efficacy study to evaluate the clinical effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial ischemia.
4o patients with reversible ischemia on a SPECT will be treated with direct intramyocardial injections of autologous isolated and expanded mesenchymal stem cells.Clinical and objective evaluations will be performed at baseline and during 12 months follow-up.
Enrollment
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Volunteers
Inclusion criteria
- Age 30 to 80 years Reversible ischemia on a stress SPECT Angina pectoris CCS class >_ 2 Reduced exercise time < 10 min No further revascularization options
Exclusion criteria
- Pregnant Present or history of cancer Proliferative retinopathy Systemic severe disease LVEF < 25 % NYHA > II
Trial design
Primary purpose
Allocation
Interventional model
Masking
31 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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