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MP41-17: Safety and Potential Effect of a Single Intracavernous Injection of Autologous Adipose-Derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy: A 12-month follow-up

Saturday, May 13
3:30 PM - 5:30 PM
Location: BCEC: Room 156

Presentation Authors: Martha Haahr*, Charlotte Harken Jensen, Jens Ahm Sørensen, Søren Paludan Sheikh, Lars Lund, Odense, Denmark

Introduction: Cell- and tissue-based therapeutic approaches are progressively gaining ground in the clinics. Evidence from animal models replicating post radical prostatectomy (RP) erectile dysfunction (ED) suggests intracavernous injection of stem cells as a promising treatment approach for ED. We report result from a phase 1 trial with autologous adipose derived regenerative stem cells (ADRCs) used freshly isolated after liposuction.

Methods: 21 men with ED after RP, performed 6-17 months prior were enrolled in this prospective phase 1 open label and single-arm study. All men tried full pharmacological intervention (PDE-5 or PGE1 analog) with insufficient effect prior to inclusion. The primary objective was to assess the safety of ADRC and secondary recovery of erectile function. Each patient received one treatment and was seen 1,3,6 and 12 months after the intracavernosal ADRCs transplantation. Erectile function was assessed by IIEF and EHS scores. Adipose tissue collection was performed with water-jet-assisted liposuction during general anesthesia. Following immediate isolation of ADRCs, using an automated processing Celution 800/CRS system, these were injected into corpus cavernosum. The Danish Health and Medicines Authority and Ethical Committee approval has been obtained.

Results: Overall, 8 of 14 (57%) continent men recovered their erectile function, and could implement sexual intercourse after 6 months and the effect sustained 12 months after stem cell treatment. Post-hoc stratification according to content/incontinent status was performed. Efficacy was solely demonstrated in the patients that were continent at inclusion. Accordingly, in continent men IIEF-5 score was unchanged one month after the treatment 6 (4) (median (IQR) (mean 8.5 (95% CI 5.26-11.3)) RM one-way ANOVA with Sidaks' multiple comparisons test), but significantly increased after 6 months to 11 (17) (14.27 (9.834 to 18.70), p< 0.001) and at 12 months (9 (20) (13.2 (8.833-17.57), p< 0.05). In contrast, incontinent men did not regain erectile function (median IIEF-5 6 months= 5 (1) 5.33 (95% CI 4.791-5.875)). No serious adverse events but 8 minor events related to the liposuction were reported.


Conclusions: Freshly isolated autologous ADRCs statistically significantly improved erectile function in continent men. No serious adverse events were recorded after injection or during follow-up. We suggest that ADRCs represent a promising novel interventional therapy of ED following RP.

Source Of Funding: None

Lars Lund

Odense University Hosiptal and Clinical Institute, University of Southern Denmark

Lars Lund is appointed as consultant and Professor at the Department of Urology, Odense University Hospital and Clinical Institute, University of Southern Denmark the 1st October 1, 2012. Since 2016 he is also adjunct professor at Aalborg University Hospital. Lars Lund's research areas are cryocoagulations (freezing treatment) of cancer especially in the kidney and prostate. His teams do research in stem cell therapy for erectile dysfunction and low-intensity shockwave treatment for erectile dysfunction and deteriorated kidney function.
Lars Lund was born in Aalborg, and graduated from Aalborghus Amtsgymnasium in 1975. Then he went to Aarhus, where he studied medicine and received his degree in 1984. The surgical and urological education took place in Aalborg, Randers, Skejby Urological Division, and was completed after one year's stay at the Child Surgical Department, Prince of Wales University Hospital, Hong Kong. In 1994 he became a specialist in surgery and 1998 in urology. Lars Lund has been employed as a head of urology and surgery at Viborg Hospital since 1998, interrupted by one year's stay at Vanderbilt University, Nashville, Tennessee in 2006.
He defended his doctoral dissertation on varicocele testis in 2001.
Lars Lund has been a clinical lecturer since 1994 and postgraduate clinical lecturer in urology at CEPOME, Aarhus University in the period 2003 to 2012. Lars Lund has published over 130 scientific articles. Has been and is the main supervisor of several Ph-D students, elite students and research students at SDU. He is a member of several committees locally, vice president of the Danish Urological Society, censor of the surgical thesis, consultant in patient care urology, and is a member of the national multidisciplinary group for kidney cancer in Denmark (Darenca).

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MP41-17: Safety and Potential Effect of a Single Intracavernous Injection of Autologous Adipose-Derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy: A 12-month follow-up



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