In:
Urologia Internationalis, S. Karger AG, Vol. 101, No. 3 ( 2018), p. 358-365
Abstract:
〈 b 〉 〈 i 〉 Objectives: 〈 /i 〉 〈 /b 〉 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. 〈 b 〉 〈 i 〉 Patients and Methods: 〈 /i 〉 〈 /b 〉 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. 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 procedure was well tolerated and no patients reported significant adverse effects. There was significant improvement of IIEF-15 and EHS; IIEF-15 ( 〈 i 〉 p 〈 /i 〉 = 0.04), Erectile Function ( 〈 i 〉 p 〈 /i 〉 = 0.03), Sexual Desire ( 〈 i 〉 p 〈 /i 〉 = 0.04), Intercourse Satisfaction ( 〈 i 〉 p 〈 /i 〉 = 0.04), and Overall Satisfaction ( 〈 i 〉 p 〈 /i 〉 = 0.04). 〈 b 〉 〈 i 〉 Conclusion: 〈 /i 〉 〈 /b 〉 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.
Type of Medium:
Online Resource
ISSN:
0042-1138
,
1423-0399
Language:
English
Publisher:
S. Karger AG
Publication Date:
2018
detail.hit.zdb_id:
1464417-4
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