A Phase 2 interventional study of Adipose-Derived Regenerative Cells and Placebo in ED and Adipose Derived Stem Cells, sponsored by Odense University Hospital. Completed at 1 site in Denmark. Open to male participants. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Odense University Hospital · Phase 2, Interventional, and Treatment
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.
Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
One injection of Ringer Lactate
Other: Placebo
Injection of adipose derived regnerative cells
Drug: Adipose-Derived Regenerative Cells
Adipose-derived regenerative cells was injected into the corpus cavernosum.
Injection of ringer lactate
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.
Time frame: 12 months
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 1. Enlarged but not firm 2. Firm, but not hard enough for penetration 3. Hard enough for penetration, but not fully rigid 4. fully rigid and completely hard. A higher score after 6 month means that the erection is better than before intervention.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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 %
Time frame: 6 months
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Odense University Hospital