Ji YH. et al., 2025: High-activity placenta-derived mesenchymal stem cells combined with low-intensity extracorporeal shock wave therapy for diabetic erectile dysfunction: a prospective randomized controlled trial.

Friday, 24 October 2025

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Yun-Hua Ji # 1, Yi-Fan Zhang # 2, Xiao Tan # 1, Hao-Zhong Hou 1, Zhen Yao 3, Bo Zhang 4
1Department of Urology, The Second Affiliated Hospital, Air Force Military Medical University, Xi'an, 710032, Shanxi, China.
2Department of Urology, The First Affiliated Hospital, Air Force Military Medical University, Xi'an, 710032, Shanxi, China.
3Department of Urology, The Second Affiliated Hospital, Air Force Military Medical University, Xi'an, 710032, Shanxi, China.
4Department of Urology, The Second Affiliated Hospital, Air Force Military Medical University, Xi'an, 710032, Shanxi, China. z
#Contributed equally.

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.

Stem Cell Res Ther. 2025 Jul 9;16(1):359. doi: 10.1186/s13287-025-04499-9. PMID: 40629484; PMCID: PMC12239383

Comments 1

Jens Rassweiler on Friday, 24 October 2025 11:00

The paper explores a novel approach to treating diabetic erectile dysfunction (ED) using a combination of high-activity placenta-derived mesenchymal stem cells (hPMSCs) and low-intensity extracorporeal shock wave therapy (LI-ESWT).

Background
Diabetic erectile dysfunction is a common complication in diabetic patients and can significantly affect their quality of life. Traditional treatments, such as phosphodiesterase type 5 inhibitors, may not be effective for all patients, particularly those with refractory ED. The study seeks to investigate the potential benefits of combining hPMSCs, known for their regenerative qualities, with LI-ESWT, which promotes tissue repair and improves blood flow to the penis.

Study Design
Participants: The study enrolled 33 men with refractory diabetic ED. Participants were randomized into three groups (hPMSCs, LI-ESWT, and combined therapy), with a 1:1:1 ratio.

Intervention Protocol: Participants temporarily discontinued ED medications for at least two weeks prior to interventions. The study aimed to assess various efficacy endpoints using validated questionnaires and assessments over a follow-up period that included baseline measurements and 1, 3, and 6 months post-treatment using the International Index of Erectile Function (IIEF-EF), the Erection Hardness Score (EHS), Sexual Encounter Profile (SEP-2 and SEP-3), and Rigiscan parameters. Safety outcomes were also monitored throughout the study.

Results
Efficacy Measurements: The combined therapy group exhibited significantly greater improvements in total erection time compared to the individual treatment groups: At 6 months, the median total erection time was 18.20 min (IQR: 13.35–20.55) in the hPMSCs group, 11.00 min (IQR: 11.00–12.00) in the LI-ESWT group, and LI-ESWT 22.20 min (IQR: 15.20–30.25) in the H+L group ( p = 0.001). However, the effective erection time, which was 0.00 min (IQR: 0.00–0.00) H+L at baseline across all groups, improved significantly by 6 months to 11.40 min (IQR: 10.75–12.00) in the hPMSCs group, 10.70 min (IQR: 10.33–11.28) in the LI-ESWTgroup, and 11.90 min (IQR: 11.55–12.35) in the H+L group, which does not represent a real „clinically“ favorable result for the combination therapy.

Erection Hardness Score (EHS) showed substantial improvement, with 70% (vs. 45 and 40 %) of patients in the combined group achieving an EHS score greater than 2 at 6 months, indicating clinically significant enhancement in erectile function. This is alos reflected by the values of the IIEF-EF-scores (Fig. 2)

Safety Outcomes: The combinations of hPMSCs and LI-ESWT were well-tolerated, with no severe adverse events reported. Mild local pain was noted but resolved quickly within a week.

Discussion
The results indicate a promising strategy for treating diabetic ED by implementing a dual approach that leverages both regenerative medicine (through the use of stem cells) and a physical therapy modality (LI-ESWT). This combination may address the underlying causes of ED more effectively than either treatment alone. The study’s findings contribute valuable insights into the potential for innovative therapies in urology, particularly for hard-to-treat conditions like diabetic ED.

Limitations
While the study provides encouraging results, it is important to recognize limitations such as the small sample size (n= 33) and short follow-up duration. Larger clinical trials with longer follow-up periods may be necessary to establish the long-term efficacy and safety of this combined therapy approach, particularly the effective erection time needs to be further evaluated.
Conclusion
In summary, the prospective randomized controlled trial suggests that combining high-activity placenta-derived mesenchymal stem cells with low-intensity extracorporeal shock wave therapy is a safe and effective option for improving erectile function in patients suffering from diabetic erectile dysfunction. The study highlights the potential for combining different therapeutic modalities to enhance treatment outcomes in patients with complex medical conditions. This approach is currently used more and more in centers of sexual medicine.

Jens Rassweiler

Background
Diabetic erectile dysfunction is a common complication in diabetic patients and can significantly affect their quality of life. Traditional treatments, such as phosphodiesterase type 5 inhibitors, may not be effective for all patients, particularly those with refractory ED. The study seeks to investigate the potential benefits of combining hPMSCs, known for their regenerative qualities, with LI-ESWT, which promotes tissue repair and improves blood flow to the penis.

Study Design
Participants: The study enrolled 33 men with refractory diabetic ED. Participants were randomized into three groups (hPMSCs, LI-ESWT, and combined therapy), with a 1:1:1 ratio.

Intervention Protocol: Participants temporarily discontinued ED medications for at least two weeks prior to interventions. The study aimed to assess various efficacy endpoints using validated questionnaires and assessments over a follow-up period that included baseline measurements and 1, 3, and 6 months post-treatment using the International Index of Erectile Function (IIEF-EF), the Erection Hardness Score (EHS),  Sexual Encounter Profile (SEP-2 and SEP-3), and Rigiscan parameters. Safety outcomes were also monitored throughout the study.

Results
Efficacy Measurements: The combined therapy group exhibited significantly greater improvements in total erection time compared to the individual treatment groups: At 6 months, the median total erection time was 18.20 min (IQR: 13.35–20.55) in the hPMSCs group, 11.00 min (IQR: 11.00–12.00) in the LI-ESWT group, and LI-ESWT 22.20 min (IQR: 15.20–30.25) in the H+L group ( p = 0.001). However, the effective erection time, which was 0.00 min (IQR: 0.00–0.00) H+L at baseline across all groups, improved significantly by 6 months to 11.40 min (IQR: 10.75–12.00) in the hPMSCs group, 10.70 min (IQR: 10.33–11.28) in the LI-ESWTgroup, and 11.90 min (IQR: 11.55–12.35) in the H+L group, which does not represent a real „clinically“ favorable result for the combination therapy.

Erection Hardness Score (EHS) showed substantial improvement, with 70%  (vs. 45 and 40 %) of patients in the combined group achieving an EHS score greater than 2 at 6 months, indicating clinically significant enhancement in erectile function. This is alos reflected by the values of the IIEF-EF-scores (Fig. 2)
	[img]https://www.storzmedical.com/images/blog/Ji.png[/img]
Safety Outcomes: The combinations of hPMSCs and LI-ESWT were well-tolerated, with no severe adverse events reported. Mild local pain was noted but resolved quickly within a week.

Discussion
The results indicate a promising strategy for treating diabetic ED by implementing a dual approach that leverages both regenerative medicine (through the use of stem cells) and a physical therapy modality (LI-ESWT). This combination may address the underlying causes of ED more effectively than either treatment alone. The study’s findings contribute valuable insights into the potential for innovative therapies in urology, particularly for hard-to-treat conditions like diabetic ED.

Limitations
While the study provides encouraging results, it is important to recognize limitations such as the small sample size  (n= 33) and short follow-up duration. Larger clinical trials with longer follow-up periods may be necessary to establish the long-term efficacy and safety of this combined therapy approach, particularly the effective erection time needs to be further evaluated.
Conclusion
In summary, the prospective randomized controlled trial suggests that combining high-activity placenta-derived mesenchymal stem cells with low-intensity extracorporeal shock wave therapy is a safe and effective option for improving erectile function in patients suffering from diabetic erectile dysfunction. The study highlights the potential for combining different therapeutic modalities to enhance treatment outcomes in patients with complex medical conditions. This approach is currently used more and more in centers of sexual medicine.

Jens Rassweiler

The paper explores a novel approach to treating diabetic erectile dysfunction (ED) using a combination of high-activity placenta-derived mesenchymal stem cells (hPMSCs) and low-intensity extracorporeal shock wave therapy (LI-ESWT). Background Diabetic erectile dysfunction is a common complication in diabetic patients and can significantly affect their quality of life. Traditional treatments, such as phosphodiesterase type 5 inhibitors, may not be effective for all patients, particularly those with refractory ED. The study seeks to investigate the potential benefits of combining hPMSCs, known for their regenerative qualities, with LI-ESWT, which promotes tissue repair and improves blood flow to the penis. Study Design Participants: The study enrolled 33 men with refractory diabetic ED. Participants were randomized into three groups (hPMSCs, LI-ESWT, and combined therapy), with a 1:1:1 ratio. Intervention Protocol: Participants temporarily discontinued ED medications for at least two weeks prior to interventions. The study aimed to assess various efficacy endpoints using validated questionnaires and assessments over a follow-up period that included baseline measurements and 1, 3, and 6 months post-treatment using the International Index of Erectile Function (IIEF-EF), the Erection Hardness Score (EHS), Sexual Encounter Profile (SEP-2 and SEP-3), and Rigiscan parameters. Safety outcomes were also monitored throughout the study. Results Efficacy Measurements: The combined therapy group exhibited significantly greater improvements in total erection time compared to the individual treatment groups: At 6 months, the median total erection time was 18.20 min (IQR: 13.35–20.55) in the hPMSCs group, 11.00 min (IQR: 11.00–12.00) in the LI-ESWT group, and LI-ESWT 22.20 min (IQR: 15.20–30.25) in the H+L group ( p = 0.001). However, the effective erection time, which was 0.00 min (IQR: 0.00–0.00) H+L at baseline across all groups, improved significantly by 6 months to 11.40 min (IQR: 10.75–12.00) in the hPMSCs group, 10.70 min (IQR: 10.33–11.28) in the LI-ESWTgroup, and 11.90 min (IQR: 11.55–12.35) in the H+L group, which does not represent a real „clinically“ favorable result for the combination therapy. Erection Hardness Score (EHS) showed substantial improvement, with 70% (vs. 45 and 40 %) of patients in the combined group achieving an EHS score greater than 2 at 6 months, indicating clinically significant enhancement in erectile function. This is alos reflected by the values of the IIEF-EF-scores (Fig. 2) [img]https://www.storzmedical.com/images/blog/Ji.png[/img] Safety Outcomes: The combinations of hPMSCs and LI-ESWT were well-tolerated, with no severe adverse events reported. Mild local pain was noted but resolved quickly within a week. Discussion The results indicate a promising strategy for treating diabetic ED by implementing a dual approach that leverages both regenerative medicine (through the use of stem cells) and a physical therapy modality (LI-ESWT). This combination may address the underlying causes of ED more effectively than either treatment alone. The study’s findings contribute valuable insights into the potential for innovative therapies in urology, particularly for hard-to-treat conditions like diabetic ED. Limitations While the study provides encouraging results, it is important to recognize limitations such as the small sample size (n= 33) and short follow-up duration. Larger clinical trials with longer follow-up periods may be necessary to establish the long-term efficacy and safety of this combined therapy approach, particularly the effective erection time needs to be further evaluated. Conclusion In summary, the prospective randomized controlled trial suggests that combining high-activity placenta-derived mesenchymal stem cells with low-intensity extracorporeal shock wave therapy is a safe and effective option for improving erectile function in patients suffering from diabetic erectile dysfunction. The study highlights the potential for combining different therapeutic modalities to enhance treatment outcomes in patients with complex medical conditions. This approach is currently used more and more in centers of sexual medicine. Jens Rassweiler

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