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

NCT02240823 | Unknown Phase 1 DMC

• 1 other identifier: 2013-Afd-L
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Delayed Graft Function

Keywords

Erectile Function; Mesenchymal Stromal Cells; Stem Cell

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  Adverse Events

  1 month after surgery

Secondary Outcomes (1)

• Improvement in erectile function, measured i IIEF-5 score

  1,3,6,9 and 12 months

Study Arms (1)

adipose derived stem cells

EXPERIMENTAL

Other: adipose derived stem cells

Interventions

adipose derived stem cells OTHER

adipose derived stem cells

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Martha Haahr M.D: lead
• Odense University Hospital: collaborator

Study Sites (1)

Odense Universitet Hospital

Odense, 5000, Denmark

Location

Related Publications (2)

• Haahr MK, Jensen CH, Toyserkani NM, Andersen DC, Damkier P, Sorensen 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.

  PMID: 27077129 DERIVED

• 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. No abstract available.

  PMID: 25974235 DERIVED

MeSH Terms

Conditions

Delayed Graft Function

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: June 3, 2014
• First Posted: September 16, 2014
• Study Start: April 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: September 1, 2016
• Last Updated: October 16, 2015

Record last verified: 2015-10

Locations

DK (1)