Department of Urology, Dalhousie University, Halifax, NS, Canada; Department of Urology, Miller School of Medicine, University of Miami, Miami, FL, USA.
Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL, USA.
J Sex Med. 2020 Apr;17(4):695-701. doi: 10.1016/j.jsxm.2020.01.003. Epub 2020 Feb 12.
Despite limited human data, there is a growing interest in the use of stem cell therapy (SCT) for erectile dysfunction (ED).
To determine the effect of transendocardial stem cell injection on erectile function on men with cardiomyopathy and ED.
We used International Index of Erectile Function (IIEF) scores collected from men enrolled in 3 separate randomized controlled trials: Comparison of Allogeneic vs Autologous Bone Marrow-Derived Mesenchymal Stem Cells Delivered by Transendocardial Injection in Patients With Ischemic Cardiomyopathy (POSEIDON), Transendocardial Mesenchymal Stem Cells and Mononuclear Bone Marrow Cells for Ischemic Cardiomyopathy (TAC-HFT), and Dose Comparison Study of Allogeneic Mesenchymal Stem Cells in Patients With Ischemic Cardiomyopathy (TRIDENT). These trials recruited patients with ischemic cardiomyopathy and ejection fraction less than 50%. Inclusion and exclusion criteria were identical in all 3 trials. The primary intervention in these trials included transendocardial stem cell injection of stem cells or placebo via cardiac catheterization. The follow-up period was 1 year. IIEF data were collected at baseline and at multiple time points in each trial.
We investigated erectile function over time based on cell dose, cell source (autologous vs allogenic), cell type (mesenchymal stem cells vs bone marrow mononuclear cells), and comparing men who received SCT with those who received placebo.
A total of 36 men were identified with complete IIEF data. 8 men received placebo injection, and 28 received SCT. The median age was 66.5 years. Comorbidities were similar among all men. Analysis was performed on men with ED, defined by an IIEF-EF score of 24 or less. In the placebo and all-comer SCT group, the median IIEF-EF score was 5 [1-8] and 5 [1-15] at baseline and was 3.5 [3-5.8] and 7 [1-18] at 12 months (P > .05). When analyzed by cell dose, the IIEF-EF score in men who received 200 million cells increased significantly over 12 months (14 [4-23] to 20 [15-24.5], P = .014.) Similarly, an autologous cell source resulted in a similar increase from baseline to 12 months (14 [3.8-23.3] to 20 [12-22], P = .030).
Erectile function may improve after systemic delivery of SCT in men with ischemic cardiomyopathy and at least mild ED.
STRENGTHS & LIMITATIONS: This post hoc analysis is the first to investigate the effect of SCT on erectile function using randomized, placebo-controlled data. Weaknesses include that ED was not a primary end point, and men were not originally recruited based on erectile function.
Future trials on systemic delivery of SCT for ED should focus on high cell dose and autologous cell source, as these seem to provide the best response in men with at least mild ED. Ory J, Saltzman RG, Blachman-Braun R, et al. The Effect of Transendocardial Stem Cell Injection on Erectile Function in Men With Cardiomyopathy: Results From the TRIDENT, POSEIDON, and TAC-HFT Trials. J Sex Med 2020;17:695-701.
尽管人类数据有限，但人们对使用干细胞疗法（SCT）治疗勃起功能障碍（ED）越来越感兴趣。
确定经心内膜干细胞注射对患有心肌病和 ED 的男性勃起功能的影响。
我们使用了来自 3 项单独的随机对照试验的男性国际勃起功能指数（IIEF）评分：同种异体与自体骨髓衍生间充质干细胞经心内膜注射治疗缺血性心肌病患者的比较（POSEIDON）、经心内膜间充质干细胞和单核骨髓细胞治疗缺血性心肌病（TAC-HFT）以及同种异体间充质干细胞在缺血性心肌病患者中的剂量比较研究（TRIDENT）。这些试验招募了缺血性心肌病和射血分数小于 50%的患者。所有 3 项试验的纳入和排除标准均相同。这些试验中的主要干预措施包括通过心导管术进行经心内膜干细胞注射干细胞或安慰剂。随访时间为 1 年。在基线和每个试验的多个时间点收集 IIEF 数据。
共确定了 36 名具有完整 IIEF 数据的男性。8 名男性接受安慰剂注射，28 名男性接受 SCT。中位年龄为 66.5 岁。所有男性的合并症相似。对勃起功能障碍（定义为 IIEF-EF 评分 24 或更低）的男性进行了分析。在安慰剂和所有接受 SCT 的男性中，IIEF-EF 评分在基线时分别为 5 [1-8] 和 5 [1-15]，在 12 个月时分别为 3.5 [3-5.8] 和 7 [1-18]（P>.05）。按细胞剂量分析时，接受 2 亿个细胞的男性 12 个月后 IIEF-EF 评分显著增加（14 [4-23] 至 20 [15-24.5]，P=0.014）。同样，自体细胞来源也导致从基线到 12 个月时的类似增加（14 [3.8-23.3] 至 20 [12-22]，P=0.030）。
在缺血性心肌病和至少轻度 ED 的男性中，全身性 SCT 后勃起功能可能会改善。
这是首次使用随机、安慰剂对照数据研究 SCT 对勃起功能的影响的事后分析。其局限性包括 ED 不是主要终点，且男性并非最初根据勃起功能招募。
未来关于 ED 的全身性 SCT 治疗的试验应重点关注高细胞剂量和自体细胞来源，因为这些似乎为至少轻度 ED 的男性提供了最佳反应。
