Delayed Graft FunctionPhase 1NCT02240823
Can Fat Derived Stem Cells (SVF) be Used in the Treatment of Erectile Dysfunction After Prostatectomy
A Phase 1 study testing adipose derived stem cells in people with Delayed Graft Function, run by Martha Haahr M.D at 1 site in Denmark.
Trial summary
Prostate cancer is the most common cancer among Danish men, and the incidence is increasing. Studies have shown a high number needed to treat for each saved prostate cancer related death. Since the treatments incur many complications, there is a need to address these. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Delayed Graft Function
- What is being tested?
- adipose derived stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2014to Sep 2016
- Phase
- Phase 1
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men who have had prostate removed due to prostate cancer regardless bilateral nerve-sparing, unilateral nerve-sparing or non-nerve-sparing surgical technique.
- Erectile dysfunction
- Sexually active/ have sexual interest
- We make no distinction for the patients are operated with
Who cannot join
- Absence of sexual interest.
- Patients with impaired health condition where anesthesia would be a risk of complications.
- BMI below 20.
- Small amount of abdominal fat assessed by. Ct abdomen.
- Patients on anticoagulant treatment.
- Men with suspicion of residual tumor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study. Can Fat Derived Stem Cells (SVF) be Used in the Treatment of Erectile Dysfunction After Prostatectomy
Prostate cancer is the most common cancer among Danish men, and the incidence is increasing. Studies have shown a high number needed to treat for each saved prostate cancer related death. Since the treatments incur many complications, there is a need to address these. After prostatectomy, 80% experience erectile dysfunction. Sexual life is a central part of people's identity, self-esteem and quality of life. Stem cells have generated a large amount of promising data suggesting that stem cells can alleviate erectile dysfunction, by regenerating nerves as well as endothelial and smooth muscle cells in the corpus cavernous.
Read the detailed description
Prostate cancer is the most common cancer among Danish men, and the incidence is increasing. Studies have shown a high number needed to treat for each saved prostate cancer related death.
After prostatectomy, 80% experience erectile dysfunction. Sexual life is a central part of people's identity, self-esteem and quality of life. Stem cells have generated a large amount of promising data suggesting that stem cells can alleviate erectile dysfunction, by regenerating nerves as well as endothelial and smooth muscle cells in the corpus cavernous.
Animal studies have used stem cell therapy to improve erectile dysfunction in rats after cavernous nerve damage, with invariable high success rate.
In this pilot study will include 30 patient's with erectile dysfunction 3-9 mdr after prostatectomy. The men have no spontaneous erectile function and no response to drug treatment.
Liposuction is carried out in general anesthesia. Isolation of stem cells will be done simultaneously and the stem cells injected into the corpus cavernous directly after the isolation is carried out.
This is a clinical study evaluating an innovative cell therapy procedure.The objective of this study was to evaluate the effects of injection of stem cell of adipose origin.
The project will run over a period of twelve months. Patients will be followed for a period of six months. Treatment efficacy will be assessed from validated questionnaires.
- Conditions
- Delayed Graft Function
- Being tested
- adipose derived stem cells
- Keywords
- Erectile Function, Mesenchymal Stromal Cells, Stem Cell
- Medical subject headings
- Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adipose derived stem cellsOther
| Study group | Role | What they receive |
|---|---|---|
| adipose derived stem cells | Experimental | Not described Receives: Other: adipose derived stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Adverse Events
Measured: 1 month after surgery
Secondary outcomes (1)
Improvement in erectile function, measured i IIEF-5 score
Assessed by interview and questionnaires
Measured: 1,3,6,9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startApr 2014
- Primary completionOct 2015
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Delayed Graft FunctionStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martha Haahr M.D
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Sponsor-investigator, Martha Haahr M.D, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240823
- Sponsor's protocol ID
- 2013-Afd-L
- Status last verified
- Oct 2015
- First submitted
- 3 Jun 2014
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Haahr MK, Jensen CH, Toyserkani NM, Andersen DC, Damkier P, Sorensen JA, Lund L, Sheikh SP. Safety and Potential Effect of a Single Intracavernous Injection of Autologous Adipose-Derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy: An Open-Label Phase I Clinical Trial. EBioMedicine. 2016 Jan 19;5:204-10. doi: 10.1016/j.ebiom.2016.01.024. eCollection 2016 Mar.
PubMed 27077129Khera M, Albersen M, Mulhall JP. Mesenchymal stem cell therapy for the treatment of erectile dysfunction. J Sex Med. 2015 May;12(5):1105-6. doi: 10.1111/jsm.12871. No abstract available.
PubMed 25974235
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study. Can Fat Derived Stem Cells (SVF) be Used in the Treatment of Erectile Dysfunction After Prostatectomy
- ClinicalTrials.gov ID
- NCT02240823
- Acronym / sponsor ID
- 2013-Afd-L
- Conditions
- Delayed Graft Function
- Keywords
- Erectile Function, Mesenchymal Stromal Cells, Stem Cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Martha Haahr M.DUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- Apr 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Sep 2016 (estimated)
- First posted
- 16 Sep 2014 (estimated)
- 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.
Prostate cancer is the most common cancer among Danish men, and the incidence is increasing. Studies have shown a high number needed to treat for each saved prostate cancer related death. Since the treatments incur many complications, there is a need to address these. After prostatectomy, 80% experience erectile dysfunction. Sexual life is a central part of people's identity, self-esteem and quality of life. Stem cells have generated a large amount of promising data suggesting that stem cells can alleviate erectile dysfunction, by regenerating nerves as well as endothelial and smooth muscle cells in the corpus cavernous.
Detailed description
Prostate cancer is the most common cancer among Danish men, and the incidence is increasing. Studies have shown a high number needed to treat for each saved prostate cancer related death.
After prostatectomy, 80% experience erectile dysfunction. Sexual life is a central part of people's identity, self-esteem and quality of life. Stem cells have generated a large amount of promising data suggesting that stem cells can alleviate erectile dysfunction, by regenerating nerves as well as endothelial and smooth muscle cells in the corpus cavernous.
Animal studies have used stem cell therapy to improve erectile dysfunction in rats after cavernous nerve damage, with invariable high success rate.
In this pilot study will include 30 patient's with erectile dysfunction 3-9 mdr after prostatectomy. The men have no spontaneous erectile function and no response to drug treatment.
Liposuction is carried out in general anesthesia. Isolation of stem cells will be done simultaneously and the stem cells injected into the corpus cavernous directly after the isolation is carried out.
This is a clinical study evaluating an innovative cell therapy procedure.The objective of this study was to evaluate the effects of injection of stem cell of adipose origin.
The project will run over a period of twelve months. Patients will be followed for a period of six months. Treatment efficacy will be assessed from validated questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adipose derived stem cells | Experimental | Other: adipose derived stem cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men who have had prostate removed due to prostate cancer regardless bilateral nerve-sparing, unilateral nerve-sparing or non-nerve-sparing surgical technique.
- Erectile dysfunction
- Sexually active/ have sexual interest
- We make no distinction for the patients are operated with
Key exclusion criteria (6 listed)
- Absence of sexual interest.
- Patients with impaired health condition where anesthesia would be a risk of complications.
- BMI below 20.
- Small amount of abdominal fat assessed by. Ct abdomen.
- Patients on anticoagulant treatment.
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 stem cells | Other | adipose derived stem cells |
Primary outcome
Safety and Tolerability
Time frame: 1 month after surgery
Adverse Events
1 secondary outcome
Improvement in erectile function, measured i IIEF-5 score
Time frame: 1,3,6,9 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
- Derived from this study: PubMed 27077129Haahr MK, Jensen CH, Toyserkani NM, Andersen DC, Damkier P, Sorensen JA, Lund L, Sheikh SP. Safety and Potential Effect of a Single Intracavernous Injection of Autologous Adipose-Derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy: An Open-Label Phase I Clinical Trial. EBioMedicine. 2016 Jan 19;5:204-10. doi: 10.1016/j.ebiom.2016.01.024. eCollection 2016 Mar.
- Derived from this study: PubMed 25974235Khera M, Albersen M, Mulhall JP. Mesenchymal stem cell therapy for the treatment of erectile dysfunction. J Sex Med. 2015 May;12(5):1105-6. doi: 10.1111/jsm.12871. No abstract available.
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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 1 study testing adipose derived stem cells in people with Delayed Graft Function, run by Martha Haahr M.D 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Oct 2015. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Safety and Tolerability (time frame: 1 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02240823, which also lists 2 linked publications.
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 16 Oct 2015.