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Clinical study on treatment of erectile dysfunction with mesenchymal stem cells combined with microenergy

Clinical study of high activity mesenchymal stem cells combined with microenergy in the treatment of diabetic erectile dysfunction

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059271
Enrollment
Unknown
Registered
2022-04-27
Start date
2022-06-01
Completion date
Unknown
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

erectile dysfunction

Interventions

1:Stem cell injection
2:Low energy shock wave
3:Stem cell injection combine with low energy shock wave

Sponsors

Tangdu Hospital, Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed diabetes patients aged 20-60 years; 2. Generally healthy, with stable heterosexual partner>3 months; 3. ED course = 3 months, but<10 years; 4. Moderate to severe ED, the special score of erectile function (IIEF-EF) is 5-11 points; 5. No PDE5 inhibitor or other ED treatment methods were used within 2 weeks before grouping; 6. Voluntarily agree to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Severe endocrine or neurological ED; 2. Vascular ED caused by penile artery and cavernous lesions; 3. Serious mental illness, spinal cord injury, abnormal penis anatomy, or penis hemangioma; 4. Serious chronic blood system disease, or serious respiratory, digestive and neurological diseases; 5. Previous history of radical prostatectomy, urethra or penis surgery, and lumbar pelvic urethra and penis injury; In the past year, he is recovering from cancer or has received radiotherapy in the pelvic region; 6. Poor blood pressure control (systolic blood pressure = 160mmHg or diastolic blood pressure = 100mmHg); 7. Poor blood glucose control (fasting blood glucose>7.0 mmol/L); 8. Use antiandrogen and androgen drugs, coagulation dysfunction and anticoagulant within 4 weeks; 9. Have participated in any other clinical research of medical devices or drugs in the past 3 months; 10. Other researchers think it is not suitable to participate in this experiment.

Design outcomes

Primary

MeasureTime frame
IIEF - 5 scale;

Secondary

MeasureTime frame
Rigiscan test results;EHS hardness scale;

Countries

China

Contacts

Public ContactZhang Bo

Air Force Medical University

zhangbo@fmmu.edu.cn+86 13892868973

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026