Evidence map›Paper›PMID 40629484›Full record

Trial reportStem cell research & therapy2025

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

Yun-Hua Ji, Yi-Fan Zhang, Xiao Tan, Hao-Zhong Hou, Zhen Yao, Bo Zhang

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Stem cell research & therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Yun-Hua Ji *Department of Urology, The Second Affiliated Hospital, Air Force Military Medical University, Xi'an, 710032, Shanxi, China.
Yi-Fan Zhang *Department of Urology, The First Affiliated Hospital, Air Force Military Medical University, Xi'an, 710032, Shanxi, China.
Xiao Tan *Department of Urology, The Second Affiliated Hospital, Air Force Military Medical University, Xi'an, 710032, Shanxi, China.
Hao-Zhong HouDepartment of Urology, The Second Affiliated Hospital, Air Force Military Medical University, Xi'an, 710032, Shanxi, China.
Zhen YaoDepartment of Urology, The Second Affiliated Hospital, Air Force Military Medical University, Xi'an, 710032, Shanxi, China. yaozhen1001@163.com.
Bo ZhangDepartment of Urology, The Second Affiliated Hospital, Air Force Military Medical University, Xi'an, 710032, Shanxi, China. zhangbo_tduro@163.com.

Funding

Fourth Military Medical University 2021LC2110National Natural Science Foundation of China 81872077
6 · The paper itself

Abstract

objectiveTo 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).

methodsThis 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.

resultsAt 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.

conclusionThe 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.

Indexed as

Diabetes ComplicationsErectile DysfunctionExtracorporeal Shockwave TherapyMesenchymal Stem CellsMesenchymal Stem Cell TransplantationPlacentaAdultFemaleHumansMaleMiddle AgedPregnancyProspective StudiesTreatment OutcomeErectile dysfunctionhPMSCsLow-Intensity extracorporeal shock wave

Identifiers

PMID40629484
PMCPMC12239383

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.