Erectile Dysfunction Impotence of origanic origin MedDRA version: 18.1 Level: LLT Classification code 10021550 Term: Impotence System Organ Class: 100000004872 MedDRA version: 18.1 Level: LLT Classification code 10021551 Term: Impotence of organic origin System Organ Class: 100000004872
Conditions
Interventions
Product Name: ATMP: fresh isolated stem cell
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Stromal Vascular Fraction
Other descriptive name: HUMAN AUTOLOGOUS MESENCHYMAL STEM CELL
Sponsors
Odense Universitets Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Erectile function 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Denmark
Contacts
Public ContactOUH
Odense Universitetshospital
Outcome results
None listed