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

• ClinicalTrials.gov Identifier: NCT02240823
• Recruitment Status: Unknown
• First Posted: September 16, 2014
• Last Update Posted: October 16, 2015
• Sponsor: Martha Haahr M.D
• Collaborator: Odense University Hospital
• Information provided by (Responsible Party): Martha Haahr M.D, Odense University Hospital

Tracking Information

• First Submitted Date: June 3, 2014
• First Posted Date: September 16, 2014
• Last Update Posted Date: October 16, 2015
• Study Start Date: April 2014
• Actual Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 15, 2015)

Safety and Tolerability [ Time Frame: 1 month after surgery ]

Adverse Events

Original Primary Outcome Measures (submitted: September 12, 2014)

Improvement in erectile function, measured i IIEF-5 score [ Time Frame: 1,3,6,9 and 12 months ]

Assessed by interview and questionnaires

Current Secondary Outcome Measures (submitted: October 15, 2015)

Improvement in erectile function, measured i IIEF-5 score [ Time Frame: 1,3,6,9 and 12 months ]

Assessed by interview and questionnaires

Original Secondary Outcome Measures (submitted: September 12, 2014)

Safety and Tolerability [ Time Frame: 1 month after surgery ]

Adverse Events

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

Detailed 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.

• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Delayed Graft Function
• Intervention: Other: adipose derived stem cells

Study Arms

Experimental: adipose derived stem cells

Intervention: Other: adipose derived stem cells

Publications *

• Haahr MK, Jensen CH, Toyserkani NM, Andersen DC, Damkier P, Sørensen JA, Lund L, Sheikh SP. Safety and Potential Effect of a Single Intracavernous Injection of Autologous Adipose-Derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy: An Open-Label Phase I Clinical Trial. EBioMedicine. 2016 Jan 19;5:204-10. doi: 10.1016/j.ebiom.2016.01.024. eCollection 2016 Mar.
• Khera M, Albersen M, Mulhall JP. Mesenchymal stem cell therapy for the treatment of erectile dysfunction. J Sex Med. 2015 May;12(5):1105-6. doi: 10.1111/jsm.12871.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 12, 2014): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2016
• Actual Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT02240823
• Other Study ID Numbers: 2013-Afd-L
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Martha Haahr M.D, Odense University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Martha Haahr M.D
• Original Study Sponsor: Same as current
• Collaborators: Odense University Hospital
• Investigators: Not Provided
• PRS Account: Odense University Hospital
• Verification Date: October 2015