2021
DOI: 10.1159/000517364
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Safety and Efficacy of 2 Intracavernous Injections of Allogeneic Wharton’s Jelly-Derived Mesenchymal Stem Cells in Diabetic Patients with Erectile Dysfunction: Phase 1/2 Clinical Trial

Abstract: <b><i>Background and Objectives:</i></b> Stem cell therapy is a novel treatment with regenerative ability that can treat erectile dysfunction (ED). This phase 1/2 clinical trial (NCT02945449) using 2 consecutive intracavernous (IC) injections of allogeneic Wharton’s jelly-derived mesenchymal stem cells (WJ-MSCs) was studied for the first time in the treatment of diabetic patients with ED. The primary outcome was to assess the safety and tolerability, and the secondary outcome was to ass… Show more

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Cited by 19 publications
(5 citation statements)
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“…In the second, the use of two consecutive ICI of WJSC was explored for the first time in a total sample of 22 diabetic patients with ED. Positive results regarding tolerability, safety and efficacy measured via IIEF-15 and EHS questionnaires and duplex doppler penile ultrasound imaging (DPE) were observed at the 12-month follow-up [ 49 ].…”
Section: Resultsmentioning
confidence: 99%
“…In the second, the use of two consecutive ICI of WJSC was explored for the first time in a total sample of 22 diabetic patients with ED. Positive results regarding tolerability, safety and efficacy measured via IIEF-15 and EHS questionnaires and duplex doppler penile ultrasound imaging (DPE) were observed at the 12-month follow-up [ 49 ].…”
Section: Resultsmentioning
confidence: 99%
“…They all indicated that it improved EF while remaining well-tolerated and safe. Two tests found that peak systolic velocity (PSV) increased significantly [ 35 , 60 ], in the contrary, it was not apparent in these two [ 61 , 62 ]. Yiou R et al [ 35 ] demonstrated the %PNORT is improved, implying the recovery of vascular endothelial function.…”
Section: Discussionmentioning
confidence: 99%
“… Mirzaei et al [ 89 ] (2021) 20 DMED 63.8 ± 7.4 and 65.6 ± 5.1 MSCs ICI 1 month and 3 months 50–60 ×10 6 IIEF-5, CDDU, FBS, HbA1c, morning erections No serious adverse events were reported. Al Demour et al [ 90 ] (2021) 22 DMED 59.18 ± 8.45 Wharton’s jelly-derived mesenchymal stem cells ICI Immediately, 24 h, and 1, 3, 6, and 12 months 20 × 10 6 IIEF-5, EHS, CDDU No serious adverse events were reported. Koga et al [ 91 ] (2022) 38 CNIED and DMED 56 Dental pulp stem cells ICI 1 × 10 7 IIEF-5 No serious adverse events were reported.…”
Section: Stem Cell Applications In Human Clinical Trialsmentioning
confidence: 99%