Can Fat Derived Stem Cells (SVF) be Used in the Treatment of Erectile Dysfunction After Prostatectomy

Delayed Graft Function Clinical Trial

Official title:

Phase 1 Study. Can Fat Derived Stem Cells (SVF) be Used in the Treatment of Erectile Dysfunction After Prostatectomy

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02240823
• Other study ID #: 2013-Afd-L
• Status: Unknown status
• Phase: Phase 1
• First received: June 3, 2014
• Last updated: October 15, 2015
• Start date: April 2014
• Est. completion date: September 2016

Study information

• Verified date: October 2015
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prostate cancer is the most common cancer among Danish men, and the incidence is increasing. Studies have shown a high number needed to treat for each saved prostate cancer related death. Since the treatments incur many complications, there is a need to address these. After prostatectomy, 80% experience erectile dysfunction. Sexual life is a central part of people's identity, self-esteem and quality of life. Stem cells have generated a large amount of promising data suggesting that stem cells can alleviate erectile dysfunction, by regenerating nerves as well as endothelial and smooth muscle cells in the corpus cavernous.

Description:

Prostate cancer is the most common cancer among Danish men, and the incidence is increasing. Studies have shown a high number needed to treat for each saved prostate cancer related death.

After prostatectomy, 80% experience erectile dysfunction. Sexual life is a central part of people's identity, self-esteem and quality of life. Stem cells have generated a large amount of promising data suggesting that stem cells can alleviate erectile dysfunction, by regenerating nerves as well as endothelial and smooth muscle cells in the corpus cavernous.

Animal studies have used stem cell therapy to improve erectile dysfunction in rats after cavernous nerve damage, with invariable high success rate.

In this pilot study will include 30 patient's with erectile dysfunction 3-9 mdr after prostatectomy. The men have no spontaneous erectile function and no response to drug treatment.

Liposuction is carried out in general anesthesia. Isolation of stem cells will be done simultaneously and the stem cells injected into the corpus cavernous directly after the isolation is carried out.

This is a clinical study evaluating an innovative cell therapy procedure.The objective of this study was to evaluate the effects of injection of stem cell of adipose origin.

The project will run over a period of twelve months. Patients will be followed for a period of six months. Treatment efficacy will be assessed from validated questionnaires.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 30
• Est. completion date: September 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men who have had prostate removed due to prostate cancer regardless bilateral nerve-sparing, unilateral nerve-sparing or non-nerve-sparing surgical technique.

• Erectile dysfunction

• Sexually active/ have sexual interest

• We make no distinction for the patients are operated with

Exclusion Criteria:

• Absence of sexual interest.

• Patients with impaired health condition where anesthesia would be a risk of complications.

• BMI below 20.

• Small amount of abdominal fat assessed by. Ct abdomen.

• Patients on anticoagulant treatment.

• Men with suspicion of residual tumor.

Related Conditions & MeSH terms

• Delayed Graft Function
• Erectile Dysfunction

Intervention

Other:
• adipose derived stem cells

Locations

Country	Name	City	State
Denmark	Odense Universitet Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Martha Haahr M.D	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability	Adverse Events	1 month after surgery
Secondary	Improvement in erectile function, measured i IIEF-5 score	Assessed by interview and questionnaires	1,3,6,9 and 12 months