To our knowledge, this is the first report of a clinical trial of cell therapy using autologous stem cells obtained from a lipoaspirate. Our results indicate that our protocol is feasible and safe for the treatment of fistulas in Crohn's disease. The number of patients included and the uncontrolled nature of Phase I clinical trials do not allow demonstration of the effectiveness of the treatment. However, the results of the present study encourage to perform further studies in Phase II.
Locally injected eASCs appear to be a simple, safe, and beneficial therapy for perianal fistula in Crohn's disease patients. Additional studies are needed to further confirm the efficacy of the eASCs.
Background: Identification of effective treatments in severe cases of COVID-19 requiring mechanical ventilation represents an unmet medical need. Our aim was to determine whether the administration of adiposetissue derived mesenchymal stromal cells (AT-MSC) is safe and potentially useful in these patients. Methods: Thirteen COVID-19 adult patients under invasive mechanical ventilation who had received previous antiviral and/or anti-inflammatory treatments (including steroids, lopinavir/ritonavir, hydroxychloroquine and/or tocilizumab, among others) were treated with allogeneic AT-MSC. Ten patients received two doses, with the second dose administered a median of 3 days (interquartile range-IQR-1 day) after the first one. Two patients received a single dose and another patient received 3 doses. Median number of cells per dose was 0.98 £ 10 6 (IQR 0.50 £ 10 6 ) AT-MSC/kg of recipient's body weight. Potential adverse effects related to cell infusion and clinical outcome were assessed. Additional parameters analyzed included changes in imaging, analytical and inflammatory parameters.
Cell transplantation to overcome healing problems is a new surgical tool, and careful evaluation of this new modality may provide an opportunity to define a new era in the treatment of surgical challenges associated with healing disorders. Ethical and safety items do not seem to be critical problems using autologous stem cells.
This study attempts to determine the actual incidence of fistula-in-ano in the European Community, which was previously uncertain despite its major negative effects on quality of life and the high cost of treatment. Our findings indicate that the incidence of fistula-in-ano in the four countries of the EU studied is significantly higher than that in the only previously published report of the incidence of fistula-in-ano in Europe. Nevertheless, our findings confirm the general perception that fistula-in-ano is a relatively uncommon disease.
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