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

A Randomized Double-blind, Placebo-controlled Trial of Adipose-derived Regenerative Cells Injected Into Corpora Cavernosum Following Radical Prostatectomy

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.

Study Overview

• Status: Completed
• Conditions: ED; Adipose Derived Stem Cells
• Intervention / Treatment: Other: Placebo; Drug: Adipose-Derived Regenerative Cells

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Odense Universityhospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; One injection of Ringer Lactate	Other: Placebo; Injection of ringer lactate
Experimental: Active treatment; Injection of adipose derived regnerative cells	Drug: Adipose-Derived Regenerative Cells; Adipose-derived regenerative cells was injected into the corpus cavernosum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in International-Index-of-Erectile-Function 5 12 months after intervention	All paticipants answered the questionnaire International-Index-of-Erectile-Function 5 at baseline and after 12 months. The questionnaire focus on confidence, erection hardness, maintaining erection and satisfaction during intercourse. The scale of the score is from 5 to 25. The higher the score is, the better is the erectile function. A score from 5-7 means severe erectile dysfunction A score from 8-11 is moderate erectile dysfunction A score from 12-16 is mild to moderate erectile dysfunction A score from 17-21 is mild erectile dysfunction A score from respresents no erectile dysfunction. A higher score after 12 months means that the erectile function is improved.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Erectile Hardness Scale (EHS) six months after intervention	Erectile Hardness Scale (EHS) was answered at baseline and 6 months after intervention. The scale are running from 0-4, it is used to rate erection firmness for penetration. 0: no enlargement at all; Enlarged but not firm; Firm, but not hard enough for penetration; Hard enough for penetration, but not fully rigid; fully rigid and completely hard. A higher score after 6 month means that the erection is better than before intervention.	6 months
RigiScan	Changes in RigiScan scores 6 months after intervention. RigiScan is a non- invasive diagnostic devise that are used to measure penile rigidity and circumference changes during sleep. The divice consist of two loops and a monitor, and the loops are able to monitor the erection quality over time, if the values of the data improve 6 months after intervention, is the erection improved. We monitored Frequency of erections during sleep (number of erections)	6 months
RigiScan data	Changes in RigiScan scores 6 months after intervention. RigiScan is a non- invasive diagnostic devise that are used to measure penile rigidity and circumference changes during sleep. The divice consist of two loops and a monitor, and the loops are able to monitor the erection quality over time, if the values of the data improve 6 months after intervention, is the erection improved. We monitored duration of erection during sleep in minutes.	6 months
RigiScan data	Changes in RigiScan scores 6 months after intervention. RigiScan is a non- invasive diagnostic devise that are used to measure penile rigidity and circumference changes during sleep. The divice consist of two loops and a monitor, and the loops are able to monitor the erection quality over time, if the values of the data improve 6 months after intervention, is the erection improved. We monitored tumescence of erection, the expansion of the circumference in cm.	6 months
RigiScan data	Changes in RigiScan scores 6 months after intervention. RigiScan is a non- invasive diagnostic devise that are used to measure penile rigidity and circumference changes during sleep. The divice consist of two loops and a monitor, and the loops are able to monitor the erection quality over time, if the values of the data improve 6 months after intervention, is the erection improved. We monitored hardness of erection in %	6 months

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: University of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2018
• Primary Completion (Actual): March 3, 2021
• Study Completion (Actual): March 3, 2021

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2015-005140-33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data are stored in 'REDCap' that is government approved for storage of personal data, and is used to keep track of the clinical trial data via the Odense Patient data Explorative Network 'OPEN'. The aforementioned questionnaires regarding the erectile function will be filed out by the patients themselves directly into the REDCap patient file via a link.
• IPD Sharing Time Frame: 1 of January 2018 til 31 of December 2028

IPD Sharing Access Criteria

Sponsor and primary investigator will be able to access the database. Primary investigator can make permission to access the database by creating a login.

The GCP (good clinical practice) Units investigators can also access the database.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No