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PD35-07 USE OF STROMAL VASCULAR FRACTION OF ADIPOSE TISSUE IN PATIENTS WITH VASCULOGENIC ERECTILE DYSFUNCTION: EVALUATION OF CLINICAL EFFECTIVENESS AND SAFETY (PRELIMINARY RESULTS: PHASES 1-2, 6 MONTHS OF FOLLOW-UP) NCT02472431статья
Статья опубликована в высокорейтинговом журнале
Информация о цитировании статьи получена из
Web of Science
Статья опубликована в журнале из списка Web of Science и/или Scopus
Дата последнего поиска статьи во внешних источниках: 11 сентября 2018 г.
- Авторы: Chalyy Michael, Epifanova Maya, Krasnov Alexander
- Журнал: Journal of Urology
- Том: 195
- Номер: 4
- Год издания: 2016
- Издательство: Elsevier BV
- Местоположение издательства: Netherlands
- Первая страница: 846
- DOI: 10.1016/j.juro.2016.02.1079
- Аннотация: According to preclinical studies, intracavernous injections of autologous Stromal Vascular Fraction (SVF) improve erectile function. SVF is a pool of various adipose-derived cells, among which there are regenerative stem cells whose clinical use seems promising. Our main objective is to evaluate the clinical effectiveness and safety of SVF in the treatment of erectile dysfunction.The study included 6 men with vasculogenic erectile dysfunction (mean age 47±19 years; IIEF score 13±5; SEP 1.6±0.4; Erection Hardness Score 2±1.4; peak systolic velocity (as measured by penile color Doppler ultrasound) < 30 cm/sec; resistance index > 0.8; impaired endothelial function; absence of morning erections). SVF was extracted using Cytori’s Celution 800/CRS System via anterior abdominal wall and flank liposuction (liposuction volume 15-200 ml). The mean SVF cell count after preparation was 190 million cells/ml. The obtained SVF was injected intracavernously. Effectiveness and safety were evaluated at 1, 3, and 6 months after injection.At 6 months after injection, all patients showed significant improvement in erectile function. The mean IIEF scores were 14.6±7, 15±7, and 17.1±5 at 1, 3, and 6 months of follow-up, respectively. The SEP scores were 3.5±1.8 and 4±1 at 1 and 6 months, respectively. The Erection Hardness Scores were 3.5±0.4 and 4±0.5 at 1 and 6 months, respectively. In 5 patients, the peak systolic velocity exceeded 30 cm/sec and the resistance index exceeded 0.8 at 1 month of follow-up and remained the same during the whole follow-up period. All patients experienced spontaneous morning erections after treatment. No adverse effects were observed. The PSA levels remained the same.The preliminary results of our study (stages 1-2) look promising. However, to increase the validity of the study, larger clinical trials are warranted. Our study showed (1) that erectile function improvement is associated with improved arterial blood flow and improved endothelial function, and (2) that SVF administration is an effective procedure to treat erectile dysfunction.
- Добавил в систему: Краснов Александр Олегович