干细胞疗法治疗糖尿病男性勃起功能障碍:对两次海绵体内注射自体骨髓间充质干细胞的安全性和有效性进行为期24个月的随访,这是一项开放标签的二期临床试验。

IF 2.4 3区 医学 Q2 ANDROLOGY
Saddam Al Demour, Sofia Adwan, Hanan Jafar, Hussam Alhawari, Abdalla Awidi
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引用次数: 0

摘要

背景:最近,我们首次报道了连续两次阴茎海绵体内注射自体骨髓间充质干细胞(BM-MSCs)治疗糖尿病勃起功能障碍(DM-ED)患者的一期临床试验结果。在该研究的第二阶段,我们的目标是评估对另外8名糖尿病勃起功能障碍患者进行骨髓间充质干细胞IC注射的长期安全性和有效性:结果:每名患者连续接受 2 次骨髓间充质干细胞 IC 注射,并在 1、3、6、12 和 24 个月的时间点进行评估。主要结果是干细胞疗法(SCT)的耐受性和安全性,次要结果是勃起功能(EF)的改善,采用国际勃起功能指数-5(IIEF-5)、勃起硬度评分(EHS)问卷和彩色双相多普勒超声(CDDU)进行评估。IC 注射 BM-MSCs 安全且耐受性良好。与骨髓抽取和IC注射相关的轻微局部和短期不良反应均得到了观察和保守治疗。与基线相比,所有随访时间点的平均 IIEF-5、EHS 均有明显改善。在 24 个月的随访中,IIEF-5 和 EHS 平均值与基线相比均有明显下降。与基线相比,IC 注射后 3 个月的平均基础收缩速度和 20 分钟峰值收缩速度明显提高:这项 2 期临床试验证实,IC 注射间充质干细胞是安全的,并能改善 EF。结论:这项二期临床试验证实了 IC 注射 BM-MSC 是安全的,并能改善 EF,但随着时间的推移,EF 有所下降,这表明有必要对重复注射进行评估:临床试验注册:NCT02945462。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Stem cell therapy in diabetic men with erectile dysfunction: a 24-month follow-up of safety and efficacy of two intracavernous autologous bone marrow derived mesenchymal stem cells injections, an open label phase 2 clinical trial.

Background: Recently we reported results of phase 1 pilot clinical trial of 2 consecutive intracavernous (IC) injection of autologous bone marrow-derived mesenchymal stem cells (BM-MSCs) for the first time in the treatment of diabetic patients with erectile dysfunction (DM-ED). In phase 2 of this study our aim is to evaluate long term safety and efficacy of IC injections of BM-MSC on additional eight patients with DM-ED.

Results: Each patient received 2 consecutive IC injections of BM-MSC and evaluated at 1, 3, 6, 12, and 24-month time points. Primary outcome was the tolerability and safety of stem cells therapy (SCT), while the secondary outcome was improvement of erectile function (EF) as assessed using the International Index of Erectile Function-5 (IIEF-5), Erection Hardness Score (EHS) questionnaires, and Color Duplex Doppler Ultrasound (CDDU). IC injections of BM-MSCs was safe and well-tolerated. Minor local and short-term adverse events related to the bone marrow aspiration and IC injections were observed and treated conservatively. There were significant improvement in mean IIEF-5, EHS, all over the follow-up time points in comparison to the baseline. At 24-month follow up there were significant decline in the mean IIEF-5, and EHS compared to the baseline. The mean basal and 20-min peak systolic velocity was significantly higher at 3-month after the IC injections compared to baseline.

Conclusions: This phase 2 clinical trial confirmed that IC injections of BM-MSC are safe and improve EF. The decline in EF over time suggests a need for assessing repeated injections.

Clinical trial registration: NCT02945462.

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来源期刊
Basic and Clinical Andrology
Basic and Clinical Andrology Medicine-Urology
CiteScore
3.50
自引率
0.00%
发文量
21
审稿时长
22 weeks
期刊介绍: Basic and Clinical Andrology is an open access journal in the domain of andrology covering all aspects of male reproductive and sexual health in both human and animal models. The journal aims to bring to light the various clinical advancements and research developments in andrology from the international community.
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