Can Fat Stem Cells (SVF) be Used in the Treatment of Erectile Dysfunction After Prostatectomy- randomized, placebo-controlled, double-blind clinical trial.

Phase 1

• Conditions: Erectile DysfunctionImpotence of origanic origin; MedDRA version: 18.1Level: LLTClassification code 10021550Term: ImpotenceSystem Organ Class: 100000004872; MedDRA version: 18.1Level: LLTClassification code 10021551Term: Impotence of organic originSystem Organ Class: 100000004872; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2015-005140-33-DK
• Lead Sponsor: Odense Universitets Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-20
• Last Update Posted: 17 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

• prostatectomy men, no matter what surgical technique that has been used.
• Age of 18
• Organic erectile dysfunction (ED), lasting at least 6 months.
• patients with a preoperative IIEF-5 score greater than 22, and a 5-IIEF score between 5 and 20 (with or without drug potency) / EHS 1 or greater
• Involved in a monogamous, heterosexual relationship (when the questionnaires are validated for these) at least 3 months in which both parties are motivated to have or attempt intercourse
• Not interested or not able to use standard medical treatment for erectile dysfunction
• Do not have sufficient power of standard medical treatment for erectile dysfunction
• Subcutaneous fat suitable for liposuction at least 120ml
• Interested to forgo participation in any other study throughout the study, unless prior approval from the sponsor
• Skills in Danish reading and writing, so that they can answer the questionnaires.
• The ability to give informed consent.
• perfomance status 0
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

• Men who have had problems with before (general discomfort, intolerance for anesthetizing substances, venous blood clots after prostatectomy) anesthesia during the removal of the prostate.
• Significant incontinence after prostatectomy. Defined as more than two volumes DGL.
• Men where pathology study suspect of not free resektionsrande.
• Men who are in preventive anticoagulant treatment and does not tolerate interruption or replacement therapy fragmin / heparin.
• Men indicating not having pleasure in sexual intercourse with a partner or themselves.
• Previous pelvic radiation or surgery beyond prostatectomy.
• systemic autoimmune disorder
• Alcohol abuse or other substance abuse.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Erectile function<br>Tolerability;Secondary Objective: Cell characterization;Primary end point(s): IIEF5 score at 6 months compared to baseline;Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): EHS (erective hardness score) score at 6, 12 and 24 months. IIEF score after 12 and 24 months. Adverse reactions. Explorative we will examine the relationships between age, cell dose, stem cell phenotype and effect. ;Timepoint(s) of evaluation of this end point: 12 and 24 months