Can Adipose Derived Regenrative Cells be Used for Treating Erectile Dysfunction After Radical Prostatectomy

Odense University Hospital

Status and phase: Completed; Phase 2

Conditions: ED; Adipose Derived Stem Cells

Treatments: Drug: Adipose-Derived Regenerative Cells; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07355530

2015-005140-33

Details and patient eligibility

About

The goal of this study was to investigate if adipose derived regenerative cells can be used as a treatment for erectile dysfunction following radical prostatectomy.

70 participants were enrolled in the study and was performed as a double- blinded study. 35 participants in the active study arm recieved an injection into the penis of adipose derived regenerative cells, while the participants of the placebo arm recieved a placebo injection.

All 70 participants undervent liposuccion of the abdomen to harvest the adipose derived regenerative cells, and the 35 participants in the active study arm recieved their own regenerative cells.

All participants answered the questionnaires International-Index-of- Erectile function 5 and Erection Hardness Scale before treatment and after 1,3,6 and 12 months. These data was used to evaluate the effect of one injection of adipose derived regenerative cells.

Enrollment: 70 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Nervesparing robot assisted RP
• Erectile dysfunction for more than a year after RP
• Normal erectile function before RP (IIEF-5 > 22) and postoperative IIEF-5 score 5-20 or EHS 1
• Involved in a monogamous, heterosexual relationship (since questionnaires are only valid for heterosexual relationsships), where both parts are interested in sexual activities
• Insufficient effect of standard medical treatment for ED
• Subcutaneous adipose deposits on the abdomen > 120 mL
• Performance status 0
• Ability to give informed consent
• Proficiency in the Danish language to understand the questionnaires IIEF-5 and EHS

Exclusion criteria

• Problems with general anesthesia
• Incontinence after RP
• Anti-thrombotic treatment that cannot be discontinued or substituted with heparin
• No interest in sexual interaction with a partner
• Previous pelvic surgery or radiation
• Systemic autoimmune disease
• Alcohol or drug abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

One injection of Ringer Lactate

Treatment:

Other: Placebo

Active treatment

Experimental group

Description:

Injection of adipose derived regnerative cells

Treatment:

Drug: Adipose-Derived Regenerative Cells