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Study on the safety and efficacy of autologous adipose-derived SVF injection into the corpus cavernosum for the treatment of male erectile dysfunction

Study on the safety and efficacy of autologous adipose-derived SVF injection into the corpus cavernosum for the treatment of male erectile dysfunction

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084213
Enrollment
Unknown
Registered
2024-05-13
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-05-21

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

Conditions

Erection dysfunction, ED

Interventions

Group A(post radical prostatectomy: sexual nerves reserved, Group 1):3 times injection of the autologous adipose-derived SVF into the penile corpus cavernosum
Group B(post radical prostatectomy: sexual nerves reserved, Group 2):6 times injection of the autologous adipose-derived SVF into the penile corpus cavernosum
Group C(post radical prostatectomy: sexual nerves unreserved, Group 1):3 times injection of the autologous adipose-derived SVF into the penile corpus cavernosum
Group D (post radical prostatectomy: sexual nerves unreserved, Group 2):6 times injection of the autologous adipose-derived SVF into the penile corpus cavernosum
Group E (non-surgical origin, Group 1):3 times injection of the autologous adipose-derived SVF into the penile corpus cavernosum
Group F (non-surgical origin, Group 2):6 times injection of the autologous adipose-derived SVF into the penile corpus cavernosum

Sponsors

Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: a. Subject must participate and sign an informed Consent form Voluntarily, age must be at the range of 18-65 years old; b. Subject with clinically diagnosed with erectile dysfunction either caused by non-surgical origin, or post radical prostatectomy without distant metastasis; c. Subject had sexual activity before treatment and expressed a desire to remain sexually active; d. Subject had traditional treatmentss for erectile dysfunction, but the treatment were inefficacious; e. ECOG score is 0-1; f. Subject is generally in good condition and laboratory tests include, but are not limited to the following requirements: 1) Neutrophil absolute count =1.5×10^9/L, platelets =100×10^9/L, hemoglobin =90g/L 2) International Normalized Ratio(INR) or Activated Partial Thromboplastin Time(APTT) =1.5× upper limit of normal range 3) Urine routine leukocyte (-) g. Subject must use effective contraception during the study period.

Exclusion criteria

Exclusion criteria: a. Poor physical condition and unable to tolerate the treatment; b. Anticoagulant therapy is being appied or there is a clotting disorder; c. No sexual activity; d. Poorly controlled diabetes or there is a local inflammation.

Design outcomes

Primary

MeasureTime frame
International Index of Erectile Function(IIEF);Erection Hardness Score (EHS);

Secondary

MeasureTime frame
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF);

Countries

China

Contacts

Public ContactBaoan Hong

Beijing Anzhen Hospital, Capital Medical University

hbaurology@bjmu.edu.cn+86 131 6752 5426

Outcome results

None listed

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