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

NCT07355530 | Completed Phase 2 DMC

• 1 other identifier: 2015-005140-33
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

ED; Adipose Derived Stem Cells

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Changes in Erectile Hardness Scale (EHS) six months after intervention

  6 months

• RigiScan

  6 months

• RigiScan data

  6 months

• RigiScan data

  6 months

• RigiScan data

  6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

One injection of Ringer Lactate

Other: Placebo

Active treatment

EXPERIMENTAL

Injection of adipose derived regnerative cells

Drug: Adipose-Derived Regenerative Cells

Interventions

Placebo OTHER

Injection of ringer lactate

Placebo

Adipose-Derived Regenerative Cells DRUG

Adipose-derived regenerative cells was injected into the corpus cavernosum.

Active treatment

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Southern Denmark: collaborator

Study Sites (1)

Odense Universityhospital

Odense, 5000, Denmark

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: performed as a randomized, double-blind, placebo-controlled trial

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: January 21, 2026
• Study Start: January 20, 2018
• Primary Completion: March 3, 2021
• Study Completion: March 3, 2021
• Last Updated: January 21, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 1 of January 2018 til 31 of December 2028
• 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.

Locations

DK (1)