Abstract：
BACKGROUND: Clinical trials of cell therapy for erectile dysfunction (ED) and Peyronie\'s disease (PD) were recently conducted after preclinical studies.
OBJECTIVE: The aims of this study are to give an update on biotherapy for ED and PD and to describe the regulatory framework for these therapies.
METHODS: A literature review was performed through PubMed and Clinical.trials.gov addressing cell therapy for ED and PD and using following keywords \"erectile dysfunction\", \"Peyronie\'s disease\", \"stem cell\", and \"platelet-rich plasma\".
RESULTS: Preclinical studies in rodent models have shown the potential benefit of cell therapy for ED after radical prostatectomy or caused by metabolic diseases, and PD. The tissues used to obtain the therapeutic product were bone marrow, adipose tissue and blood (PRP, platelet-rich plasma). Mechanism of action was shown to be temporary and mainly paracrine. Four clinical trials were published concerning ED after radical prostatectomy and in diabetic patients and one for PD. Eleven clinical trials including three randomized trials are currently going on. Preclinical and preliminary clinical results suggested the possibility to improve spontaneous erectile function and response to pharmaceutical treatment in initially non-responder patients. This effect is mediated by an improvement of penile vascularization. A reduction of penile curvature without side effect was noted after injections into the plaque of PD patients. Most of these therapeutic strategies using autologous cells were considered as \"Advanced Therapy Medicinal Products\" with strict regulatory frameworks imposing heavy constraints, in particular in case of \"substantial\" modification of the cells. The regulatory framework remains unclear and more permissive for PRP and cell therapy processes with extemporaneous preparation/injection and no \"substantial\" modifications.
CONCLUSIONS: First results on cell therapy for ED and PD are promising. The regulatory framework can significantly change according to cell preparations and origins leading to various constraints. This regulatory framework is crucial to consider for the choice of the procedure.
OBJECTIVE: The aims of this study are to give an update on biotherapy for ED and PD and to describe the regulatory framework for these therapies.
METHODS: A literature review was performed through PubMed and Clinical.trials.gov addressing cell therapy for ED and PD and using following keywords \"erectile dysfunction\", \"Peyronie\'s disease\", \"stem cell\", and \"platelet-rich plasma\".
RESULTS: Preclinical studies in rodent models have shown the potential benefit of cell therapy for ED after radical prostatectomy or caused by metabolic diseases, and PD. The tissues used to obtain the therapeutic product were bone marrow, adipose tissue and blood (PRP, platelet-rich plasma). Mechanism of action was shown to be temporary and mainly paracrine. Four clinical trials were published concerning ED after radical prostatectomy and in diabetic patients and one for PD. Eleven clinical trials including three randomized trials are currently going on. Preclinical and preliminary clinical results suggested the possibility to improve spontaneous erectile function and response to pharmaceutical treatment in initially non-responder patients. This effect is mediated by an improvement of penile vascularization. A reduction of penile curvature without side effect was noted after injections into the plaque of PD patients. Most of these therapeutic strategies using autologous cells were considered as \"Advanced Therapy Medicinal Products\" with strict regulatory frameworks imposing heavy constraints, in particular in case of \"substantial\" modification of the cells. The regulatory framework remains unclear and more permissive for PRP and cell therapy processes with extemporaneous preparation/injection and no \"substantial\" modifications.
CONCLUSIONS: First results on cell therapy for ED and PD are promising. The regulatory framework can significantly change according to cell preparations and origins leading to various constraints. This regulatory framework is crucial to consider for the choice of the procedure.
摘要：
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