Overview

This trial is active, not recruiting.

Condition delayed graft function
Treatment adipose derived stem cells
Phase phase 1
Sponsor Martha Haahr M.D
Collaborator Odense University Hospital
Start date April 2014
End date October 2015
Trial size 30 participants
Trial identifier NCT02240823, 2013-Afd-L

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
adipose derived stem cells

Primary Outcomes

Measure
Safety and Tolerability
time frame: 1 month after surgery

Secondary Outcomes

Measure
Improvement in erectile function, measured i IIEF-5 score
time frame: 1,3,6,9 and 12 months

Eligibility Criteria

Male participants at least 18 years old.

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.

Additional Information

Official title Phase 1 Study. Can Fat Derived Stem Cells (SVF) be Used in the Treatment of Erectile Dysfunction After Prostatectomy
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Odense University Hospital.