Saddam Al Demour1, Hanan Jafar2,3, Sofia Adwan2, Abedallatif AlSharif4, Hussam Alhawari5, Adel Alrabadi1, Ayman Zayed5, Ahmad Jaradat1, Abdalla Awidi2,5. 1. Department of Special Surgery/Division of Urology, The University of Jordan, School of Medicine, Amman, Jordan. 2. Cell Therapy Center, The University of Jordan, Amman, Jordan. 3. Department of Anatomy and Histology, The University of Jordan, School of Medicine, Amman, Jordan. 4. Department of Diagnostic Radiology and Nuclear Medicine, The University of Jordan, School of Medicine, Amman, Jordan. 5. Department of Medicine, The University of Jordan, School of Medicine, Amman, Jordan.
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.
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 diabeticpatients 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 diabeticpatients 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 diabeticpatients with ED.
Authors: Russell G Saltzman; Roei Golan; Thomas A Masterson; Aditya Sathe; Ranjith Ramasamy Journal: Int J Impot Res Date: 2022-09-06 Impact factor: 2.408
Authors: Joseph M Israeli; Soum D Lokeshwar; Iakov V Efimenko; Thomas A Masterson; Ranjith Ramasamy Journal: Int J Impot Res Date: 2021-11-06 Impact factor: 2.408
Authors: James L Liu; Kevin Y Chu; Andrew T Gabrielson; Run Wang; Landon Trost; Gregory Broderick; Kelvin Davies; Gerald Brock; John Mulhall; Ranjith Ramasamy; Trinity J Bivalacqua Journal: Sex Med Date: 2021-05-14 Impact factor: 2.491