Bonanni Michela, Rehak Laura, Massaro Gianluca, Benedetto Daniela, Matteucci Andrea, Russo Giulio, Esperto Francesco, Federici Massimo, Mauriello Alessandro, Sangiorgi Giuseppe Massimo
Department of Biomedicine and Prevention, Institute of Cardiology, University of Rome Tor Vergata, 00133 Rome, Italy.
Athena Biomedical Innovations, 50126 Florence, Italy.
Biomedicines. 2022 May 8;10(5):1091. doi: 10.3390/biomedicines10051091.
About 35% of patients affected by erectile dysfunction (ED) do not respond to oral phosphodiesterase-5 inhibitors (PDE5i) and more severe vasculogenic refractory ED affects diabetic patients. Innovative approaches, such as regenerative therapies, including stem cell therapy (SCT) and platelet-rich plasma (PRP), are currently under investigation. Recent data point out that the regenerative capacity of stem cells is strongly influenced by local immune responses, with macrophages playing a pivotal role in the injury response and as a coordinator of tissue regeneration, suggesting that control of the immune response could be an appealing approach in regenerative medicine. A new generation of autologous cell therapy based on immune cells instead of stem cells, which could change regenerative medicine for good, is discussed. Increasing safety and efficacy data are coming from clinical trials using peripheral blood mononuclear cells to treat no-option critical limb ischemia and diabetic foot. In this review, ongoing phase 1/phase 2 stem cell clinical trials are discussed. In addition, we examine the mechanism of action and rationale, as well as propose a new generation of regenerative therapies, evolving from typical stem cell or growth factor to immune cell-based medicine, based on autologous peripheral blood mononuclear cells (PBMNC) concentrates for the treatment of ED.
约35%的勃起功能障碍（ED）患者对口服磷酸二酯酶-5抑制剂（PDE5i）无反应，而更严重的血管源性难治性ED则影响糖尿病患者。目前正在研究一些创新方法，如包括干细胞疗法（SCT）和富血小板血浆（PRP）在内的再生疗法。最近的数据指出，干细胞的再生能力受到局部免疫反应的强烈影响，巨噬细胞在损伤反应中起关键作用，并作为组织再生的协调者，这表明控制免疫反应可能是再生医学中一种有吸引力的方法。本文讨论了一种基于免疫细胞而非干细胞的新一代自体细胞疗法，这种疗法可能会彻底改变再生医学。越来越多关于安全性和有效性的数据来自使用外周血单个核细胞治疗无其他选择的严重肢体缺血和糖尿病足的临床试验。在这篇综述中，讨论了正在进行的1期/2期干细胞临床试验。此外，我们研究了其作用机制和原理，并基于自体外周血单个核细胞（PBMNC）浓缩物提出了新一代再生疗法，从典型的干细胞或生长因子疗法演变为基于免疫细胞的药物，用于治疗ED。
