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Phase I and registry study of autologous bone marrow concentrate evaluated in PDE5 inhibitor refractory erectile dysfunction.
Journal of Translational Medicine ( IF 7.4 ) Pub Date : 2020-01-14 , DOI: 10.1186/s12967-019-02195-w
Mark Bieri 1 , Elias Said 1 , Gabrielle Antonini 2 , Donald Dickerson 3 , Jorge Tuma 4 , Courtney E Bartlett 5 , Amit N Patel 6 , Alexander Gershman 7
Affiliation  

BACKGROUND Bone marrow mononuclear cells have been successfully utilized for numerous regenerative purposes. In the current study, patients suffering from erectile dysfunction (ED) unresponsive to phosphodiesterase 5 inhibitors were administered autologous bone marrow concentrate delivered intracavernously utilizing a point of care FDA cleared medical device. METHODS A total of 40 patients were treated in the primary trial and 100 in the clinical registry, with the longest follow up of 12 months. RESULTS Minimal treatment associated adverse effects where observed related to short term bruising at the site of harvest or injection. No long-term adverse events were noted related to the intervention. Mean improvements in IIEF-5 score were 2 in the Caverstem 1.0 low dose group, 3 in the high dose Caverstem 1.0 group and 9 in the Caverstem 2.0 group. Furthermore, improvements peaked by 3 months and maintained at 6 months follow-up. CONCLUSION These data support the safety and efficacy of point of care, minimally to non-manipulated, non-expanded bone marrow concentrate for the treatment of ED. Trial registration Funded by Creative Medical Health, Inc.; Clinicaltrials.gov number: NCT03699943; https://clinicaltrials.gov/ct2/show/NCT03699943?term=caverstem&rank=1; initially registered December 12, 2015.

中文翻译:

在PDE5抑制剂难治性勃起功能障碍中评估了自体骨髓浓缩液的I期和注册表研究。

背景技术骨髓单核细胞已被成功地用于许多再生目的。在当前的研究中,对患有对磷酸二酯酶5抑制剂无反应的勃起功能障碍(ED)的患者,采用FDA批准的医疗点,经海绵体腔内递送自体骨髓浓缩液。方法在主要试验中共治疗40例患者,在临床注册中治疗100例,最长随访时间为12个月。结果观察到与收获或注射部位短期青肿相关的不良影响,而与最低限度的治疗相关。没有发现与干预有关的长期不良事件。在Caverstem 1.0低剂量组中IIEF-5评分的平均改善为Caverstem 1.0低组2个,在高剂量Caverstem 1.0组中3个,在Caverstem 2.0组中为9个。此外,改善在3个月达到顶峰,并在6个月的随访中得以维持。结论这些数据支持了护理点的安全性和有效性,最低限度地用于非手法,非扩张性骨髓浓缩液治疗ED。试用注册由Creative Medical Health,Inc.资助;Clinicaltrials.gov编号:NCT03699943;https://clinicaltrials.gov/ct2/show/NCT03699943?term=caverstem&rank=1; 最初于2015年12月12日注册。gov / ct2 / show / NCT03699943?term = caverstem&rank = 1; 最初于2015年12月12日注册。gov / ct2 / show / NCT03699943?term = caverstem&rank = 1; 最初于2015年12月12日注册。
更新日期:2020-01-14
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