EDPhase 2NCT07355530
Can Adipose Derived Regenrative Cells be Used for Treating Erectile Dysfunction After Radical Prostatectomy
A Phase 2 study testing Adipose-Derived Regenerative Cells in people with ED and Adipose Derived Stem Cells, run by Odense University Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- ED, Adipose Derived Stem Cells
- What is being tested?
- Adipose-Derived Regenerative Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Jan 2018to 3 Mar 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Performance status 0
- Ability to give informed consent
- Proficiency in the Danish language to understand the questionnaires IIEF-5 and EHS
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- ED, Adipose Derived Stem Cells
- Being tested
- Adipose-Derived Regenerative Cells, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose-Derived Regenerative CellsDrug
Adipose-derived regenerative cells was injected into the corpus cavernosum.
PlaceboOther
Injection of ringer lactate
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | One injection of Ringer Lactate Receives: Other: Placebo |
| Active treatment | Experimental | Injection of adipose derived regnerative cells Receives: Drug: Adipose-Derived Regenerative Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (5)
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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 %
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start20 Jan 2018
- Primary completion3 Mar 2021
- Study completion3 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EDStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- performed as a randomized, double-blind, placebo-controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355530
- Sponsor's protocol ID
- 2015-005140-33
- Other IDs
- 2015
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind, Placebo-controlled Trial of Adipose-derived Regenerative Cells Injected Into Corpora Cavernosum Following Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT07355530
- Acronym / sponsor ID
- 2015-005140-33
- Conditions
- ED, Adipose Derived Stem Cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 3 Mar 2021 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- performed as a randomized, double-blind, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboOne injection of Ringer Lactate |
| Active treatment | Experimental | Drug: Adipose-Derived Regenerative CellsInjection of adipose derived regnerative cells |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adipose-Derived Regenerative CellsAdipose-derived regenerative cells was injected into the corpus cavernosum. | Drug | Active treatment |
| PlaceboInjection of ringer lactate | Other | Placebo |
Primary outcome
Changes in International-Index-of-Erectile-Function 5 12 months after intervention
Time frame: 12 months
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.
5 secondary outcomes
Changes in Erectile Hardness Scale (EHS) six months after intervention
Time frame: 6 months
RigiScan
Time frame: 6 months
RigiScan data
Time frame: 6 months
RigiScan data
Time frame: 6 months
RigiScan data
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adipose-Derived Regenerative Cells in people with ED and Adipose Derived Stem Cells, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in International-Index-of-Erectile-Function 5 12 months after intervention (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.