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HTA of cardiopoietic stem cells therapy for secondary heart failure due to myocardial ischemia in Spain
The device upon which the report was based is developed by Celyad (S.A., Mont-Saint-Guibert, Belgium) (former Cardio3 Biosciences), with the marketed name C3BS-CQR-1 (C-Cure®). This system of cardiopoietic regenerative cell therapy is the second generation of stem cell therapy from a product prepared from the culture and replication of autologous bone marrow cells, derived from mesenchymal stem cells differentiated later into cardiopoietic stem cells. The approach is percutaneous endoventricular. Through femoral access, the resulting cells are administered through an endoventricular injection catheter with approximately 600 x 10 cells in about 20 injections to regenerate damaged heart tissue, to achieve both increase viability and improve function ventricular and re-modelling, in those patients with cardiac dysfunction as a consequence of myocardial ischemia.
The authors have performed a systematic search of the literature on the following websites: Medline, Embase and Web of science. They have also considered the clinical trial registries: Cochrane Library and EuroScan, accompanied by a manual search of the web. Many publications were found, but the authors revealed that they were all based on two clinical trials: C-CURE (n=47) and CHART-1 (n=315).
The C-CURE trial did not demonstrate any significant differences between the treated and the control group, with all patients generally well accepted by all patients. Only one patient’s treatment was accompanied by ventricular tachycardia that resolved with cardioversion. At 24 months of follow-up, no adverse events were recorded with a probable or definite relationship with cell therapy. In the CHART-1 trial, 51.6% of the treated patients demonstrated adverse effects (71% of which were considered severe), compared to 53% of the patients from the control group patients (70% of which were considered severe). Out of the patients who had adverse effects, 12% and 18% have died, respectively. One part of the treated-group patients suffered from adverse events related to the percutaneous procedure: ventricular tachycardia, dissection of ascending aorta that required surgery, transient ischemic stroke, femoral artery stenosis and pericardial effusion.
Regarding the efficiency, both studies didn’t show substantial differences between the two group of patients regarding the mortality. End-systolic volume and end-diastolic volume were reduced substantially in the treated-patient group (compared to the control group) in both studies. The treated-group patients also demonstrated a more drastic improvement in the distance covered in a 6-minute walk.
The authors conclude that this procedure could increase the regenerative capacity of autologous mesenchymal stem cells to restore damaged tissue with little or no expectation of curing, opening a new method within regenerative medicine. No societal, ethical, legal, political or cultural impact would happen with the use of this technology. However, hospitals need to prepare well and establish proper procedures in order to use this technology well and ensure positive outcomes.
You can find the full article in Spanish here.
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