[Efficacy and safety of local injections treatments for Peyronie's disease: Review of the literature]. / Efficacité et tolérance des traitements locaux en injections pour le traitement de la maladie de La Peyronie : revue de la littérature.

AIM: To assess the efficacy and safety of local injection used to reduce penile curvature in Peyronie's disease. METHODS: A review of the literature was carried out according to the PRISMA guidelines (Preferred Reporting Items for Systematic Reviews and Meta-Analyzes) on the Medline database in April 2020, with the research: "collagenase"[All Fields] OR "Interferon"[All Fields] OR "verapamil"[All Fields] OR "betamethasone"[All Fields] OR "hyaluronic acid"[All Fields] OR "Platelet-Rich Plasma"[All Fields] OR "Stem Cells"[All Fields] AND "peyronie's"[All Fields] AND Controlled Clinical Trial[ptyp]. Only controlled studies with placebo group were included in this review. RESULTS: Of the 35 articles identified, 6 placebo-controlled studies were finally included. Intra-plaque injections of verapamil did not show improvement in penile curvature. Injections of interferon α 2b and clostridium histolyticum collagenase allowed a statistically significant improvement in terms of curvature reduction: 13.5 versus 4.5 degrees P<0.01) and 17 versus 9.3 degrees P<0.0001 respectively. However, interferon α 2b is not available in France for Peyronie's disease and clostridium histolyticum collagenase is no longer authorized since March 1, 2020. No controlled studies are available on corticosteroids, hyaluronic acid, platelet-rich plasma or stem cells injections. CONCLUSION: To correct the deformity in Peyronie's disease in the chronic phase, there is no effective solution currently available in France based on controlled studies. Surgery retains its place for the correction of a curvature of at least 30° associated with a sexual handicap in the stable phase, however at the cost of potential adverse effects. Stem cell or Platelet-Rich Plasma injection might be an injectable therapeutic alternative but need controlled studies.

[Biotherapies for erectile dysfunction and Peyronie's disease: Where are we now?] / Biothérapies pour les troubles de l'érection et la maladie de la Peyronie : ou en est-on ?

INTRODUCTION: Clinical trials of cell therapy for erectile dysfunction (ED) and Peyronie's disease (PD) were recently conducted after preclinical studies. AIMS: 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. MATERIALS AND 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.