High-activity placenta-derived mesenchymal stem cells combined with low-intensity extracorporeal shock wave therapy for diabetic erectile dysfunction: a prospective randomized controlled trial
Abstract Objective To evaluate the efficacy and safety of high-activity placenta-derived mesenchymal stem cells (hPMSCs) in combination with low-intensity extracorporeal shock wave therapy (LI-ESWT) for the treatment of diabetic erectile dysfunction (ED). Methods This prospective, randomized, contro...
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BMC
2025-07-01
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| Series: | Stem Cell Research & Therapy |
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| Online Access: | https://doi.org/10.1186/s13287-025-04499-9 |
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| author | Yun-Hua Ji Yi-Fan Zhang Xiao Tan Hao-Zhong Hou Zhen Yao Bo Zhang |
| author_facet | Yun-Hua Ji Yi-Fan Zhang Xiao Tan Hao-Zhong Hou Zhen Yao Bo Zhang |
| author_sort | Yun-Hua Ji |
| collection | DOAJ |
| description | Abstract Objective To evaluate the efficacy and safety of high-activity placenta-derived mesenchymal stem cells (hPMSCs) in combination with low-intensity extracorporeal shock wave therapy (LI-ESWT) for the treatment of diabetic erectile dysfunction (ED). Methods This prospective, randomized, controlled clinical trial enrolled 33 patients with refractory diabetic ED. Participants were randomly assigned in a 1:1:1 ratio to one of three groups: the hPMSCs group, the LI-ESWT group, or the combined therapy group (H + L). All subjects discontinued ED medications for at least two weeks prior to receiving the intervention. Treatment efficacy was assessed at baseline and at 1,3 and 6 months post-intervention using the International Index of Erectile Function – Erectile Function (IIEF-EF), Erection Hardness Score (EHS), Sexual Encounter Profile (SEP-2/SEP-3), and Rigiscan parameters, with safety outcomes monitored concurrently. Results At the 6-month follow-up, the combined therapy group demonstrated significantly superior outcomes compared to the individual hPMSCs and LI-ESWT groups. Specifically, total erection time reached 22.20 (15.20, 30.25) minutes (p = 0.001) and full erection time reached 11.90 (11.55, 12.35) minutes (p = 0.004) in the combined group. Moreover, EHS scores improved markedly, with 70% of patients in the combined group achieving an EHS > 2 at 6 months (p = 0.045). No severe adverse events were observed in any group; any local mild pain resolved within one week. Conclusion The combination of high-activity hPMSCs and LI-ESWT appears to be a safe and effective strategy for improving erectile function in patients with diabetic ED, demonstrating a synergistic effect in prolonging erection duration and enhancing penile hardness. This combined therapeutic approach represents a promising new option for the clinical management of diabetic ED, warranting further validation in larger, multi-center studies to confirm its long-term efficacy and safety. |
| format | Article |
| id | doaj-art-ed0ed5125d4b48fb89a80a3cc4f265e6 |
| institution | Kabale University |
| issn | 1757-6512 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Stem Cell Research & Therapy |
| spelling | doaj-art-ed0ed5125d4b48fb89a80a3cc4f265e62025-08-20T04:01:53ZengBMCStem Cell Research & Therapy1757-65122025-07-0116111010.1186/s13287-025-04499-9High-activity placenta-derived mesenchymal stem cells combined with low-intensity extracorporeal shock wave therapy for diabetic erectile dysfunction: a prospective randomized controlled trialYun-Hua Ji0Yi-Fan Zhang1Xiao Tan2Hao-Zhong Hou3Zhen Yao4Bo Zhang5Department of Urology, The Second Affiliated Hospital, Air Force Military Medical UniversityDepartment of Urology, The First Affiliated Hospital, Air Force Military Medical UniversityDepartment of Urology, The Second Affiliated Hospital, Air Force Military Medical UniversityDepartment of Urology, The Second Affiliated Hospital, Air Force Military Medical UniversityDepartment of Urology, The Second Affiliated Hospital, Air Force Military Medical UniversityDepartment of Urology, The Second Affiliated Hospital, Air Force Military Medical UniversityAbstract Objective To evaluate the efficacy and safety of high-activity placenta-derived mesenchymal stem cells (hPMSCs) in combination with low-intensity extracorporeal shock wave therapy (LI-ESWT) for the treatment of diabetic erectile dysfunction (ED). Methods This prospective, randomized, controlled clinical trial enrolled 33 patients with refractory diabetic ED. Participants were randomly assigned in a 1:1:1 ratio to one of three groups: the hPMSCs group, the LI-ESWT group, or the combined therapy group (H + L). All subjects discontinued ED medications for at least two weeks prior to receiving the intervention. Treatment efficacy was assessed at baseline and at 1,3 and 6 months post-intervention using the International Index of Erectile Function – Erectile Function (IIEF-EF), Erection Hardness Score (EHS), Sexual Encounter Profile (SEP-2/SEP-3), and Rigiscan parameters, with safety outcomes monitored concurrently. Results At the 6-month follow-up, the combined therapy group demonstrated significantly superior outcomes compared to the individual hPMSCs and LI-ESWT groups. Specifically, total erection time reached 22.20 (15.20, 30.25) minutes (p = 0.001) and full erection time reached 11.90 (11.55, 12.35) minutes (p = 0.004) in the combined group. Moreover, EHS scores improved markedly, with 70% of patients in the combined group achieving an EHS > 2 at 6 months (p = 0.045). No severe adverse events were observed in any group; any local mild pain resolved within one week. Conclusion The combination of high-activity hPMSCs and LI-ESWT appears to be a safe and effective strategy for improving erectile function in patients with diabetic ED, demonstrating a synergistic effect in prolonging erection duration and enhancing penile hardness. This combined therapeutic approach represents a promising new option for the clinical management of diabetic ED, warranting further validation in larger, multi-center studies to confirm its long-term efficacy and safety.https://doi.org/10.1186/s13287-025-04499-9Erectile dysfunctionLow-Intensity extracorporeal shock wavehPMSCs |
| spellingShingle | Yun-Hua Ji Yi-Fan Zhang Xiao Tan Hao-Zhong Hou Zhen Yao Bo Zhang High-activity placenta-derived mesenchymal stem cells combined with low-intensity extracorporeal shock wave therapy for diabetic erectile dysfunction: a prospective randomized controlled trial Stem Cell Research & Therapy Erectile dysfunction Low-Intensity extracorporeal shock wave hPMSCs |
| title | High-activity placenta-derived mesenchymal stem cells combined with low-intensity extracorporeal shock wave therapy for diabetic erectile dysfunction: a prospective randomized controlled trial |
| title_full | High-activity placenta-derived mesenchymal stem cells combined with low-intensity extracorporeal shock wave therapy for diabetic erectile dysfunction: a prospective randomized controlled trial |
| title_fullStr | High-activity placenta-derived mesenchymal stem cells combined with low-intensity extracorporeal shock wave therapy for diabetic erectile dysfunction: a prospective randomized controlled trial |
| title_full_unstemmed | High-activity placenta-derived mesenchymal stem cells combined with low-intensity extracorporeal shock wave therapy for diabetic erectile dysfunction: a prospective randomized controlled trial |
| title_short | High-activity placenta-derived mesenchymal stem cells combined with low-intensity extracorporeal shock wave therapy for diabetic erectile dysfunction: a prospective randomized controlled trial |
| title_sort | high activity placenta derived mesenchymal stem cells combined with low intensity extracorporeal shock wave therapy for diabetic erectile dysfunction a prospective randomized controlled trial |
| topic | Erectile dysfunction Low-Intensity extracorporeal shock wave hPMSCs |
| url | https://doi.org/10.1186/s13287-025-04499-9 |
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