Safety and Potential Therapeutic Effect of Two Intracavernous Autologous Bone Marrow Derived Mesenchymal Stem Cells injections in Diabetic Patients with Erectile Dysfunction: An Open Label Phase I Clinical Trial

Abstract

Objectives: This open label, phase I clinical trial (NCT02945462) using 2 consecutive intracavernous autologous bone marrow-derived mesenchymal stem cells (BM-MSCs) for the first time in the treatment of diabetic patients with erectile dysfunction (ED). The primary outcome is to assess the safety and tolerability of intracavernous autologous BM-MSCs, the secondary outcome is to assess efficacy of the procedure. Patients and Methods: Four diabetic patients with refractory ED were included. Two consecutive intracavernous autologous BM-MSC injections were performed. Tolerability was assessed immediately and at 24 h, safety was evaluated for 2 years. Efficacy was assessed using International Index of Erectile Function-15 (IIEF-15) and Erection Hardness Score (EHS) for 12 months. Results: procedure was well tolerated and no patients reported significant adverse effects. There was significant improvement of IIEF-15 and EHS; IIEF-15 (p = 0.04), Erectile Function (p = 0.03), Sexual Desire (p = 0.04), Intercourse Satisfaction (p = 0.04), and Overall Satisfaction (p = 0.04). Conclusion: This is the first human study with proven tolerability, safety and efficacy of intracavernous autologous BM-MSC injections for treatment of diabetic patients with ED.

The Combined Use of Stem Cells and Platelet Lysate Plasma for the Treatment of Erectile Dysfunction: A Pilot Study–6 Months Results

“…Our results are in accordance with the other published studies [13][14][15][16][17][18][19][20], and although there are differences in the cells used, it seems that stem cell treatment has till now positive results in erectile function. It is also very important that patients treated in the published studies had different causes of ED including mainly diabetes and radical prostatectomy or other not-specified causes and the results are in all cases positive although not similar in improvement.…”

“…Six patients experienced an increase in penile hardness and two could achieve penetration with the use of PDE-5I [13]. Several other studies have been published with promising results and ED improvement was noted in all these studies [14][15][16][17][18][19][20].…”

“…ADSCs have gained ground due to their abundance and their simplicity to collect them. However, in the published studies, several types (umbilical, placental, bone marrow, adipose-derived) have been used with similar results and without being able to support one over the other [13][14][15][16][17][18][19][20]. Secondly, should we use stem cells from the same patient or can we choose a more healthy donor?…”

“…In an effort to establish their regenerative properties, they have been used in tissue engineering and regenerative medicine approaches [10][11][12]. Several clinical studies have been published so far presenting encouraging results in the treatment of ED with stem cells [13][14][15][16][17][18][19][20].…”

Erectile Dysfunction Treatment Using Focused Linear Low-Intensity Extracorporeal Shockwaves: Single-Blind, Sham-Controlled, Randomized Clinical Trial

“…A better therapeutic effect is achieved by intracavernous treatment by prostaglandin E1. The first human study with proven tolerability, safety, and efficacy of intracavernous autologous bone marrow derived mesenchymal stem cell injections was evaluated in diabetic patients [9]. Shockwave therapy also appears to be a good alternative treatment for the prevention of ED in diabetic men.…”