Prostate CancerPhase 1/2INSTINNCT01089387
Intracavernous Bone Marrow Stem-cell Injection for Post Prostatectomy Erectile Dysfunction
A Phase 1/2 study testing injection of bone marrow mononucleated cells in people with Prostate Cancer and Erectile Dysfunction, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Erectile dysfunction is a frequent adverse event after radical prostatectomy for prostate cancer. It is the consequence of penile vascular damage, mainly arterial insufficiency and venous leakage associated with fibrosis of the corpus cavernous. Read more about this study
- Who is it for?
- Ages 45 to 70 years, men only
- Conditions the study is for
- Prostate Cancer, Erectile Dysfunction
- What is being tested?
- injection of bone marrow mononucleated cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- May 2010to Mar 2015
- Phase
- Phase 1/2
- 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 45 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Localized prostate cancer: PSA (Prostate Specific Antigen) prior to radical prostatectomy < 10 ng/ml, histopathologic analysis of the prostate showing a prostate cancer with Gleason score ≤ 7, negative margin, absence of effraction of the prostatic capsule, pT1 or pT2 N0 or NX.
- PSA=0 ng/ml 6 months after radical prostatectomy.
- Normal erectile function prior to radical prostatectomy.
- Penile arterial insufficiency and or venous leakage (doppler) at the time of inclusion: PSV <25 cm/sec, PSV >25 cm/sec, EDV>5cm/sec, RI<0,75.
Who cannot join
- Non localized prostate cancer.
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Henri Mondor-Albert Chenevier-Centre Intercommunal de Créteil
Créteil, 94101
About this study
Erectile dysfunction is a frequent adverse event after radical prostatectomy for prostate cancer.
It is the consequence of penile vascular damage, mainly arterial insufficiency and venous leakage associated with fibrosis of the corpus cavernous. Apoptosis of penile cells, including mesenchymal cells, smooth muscle cells and endothelial is believed to play an important role in the pathophysiology of post prostatectomy erectile dysfunction.
Read more
Bone marrow mononucleated cells (BMMNC) contain different cell types that may replace the damaged penile cells after radical prostatectomy. These are mainly: mesenchymal stem cells, endothelial progenitor cells and hematopoietic stem cell. Intracavernous injection of BMMNC may therefore find application in the treatment of post prostatectomy erectile dysfunction.
The aims of this phase I-II study is to test the safety of autologous intracavernous BMMNC injection and to evaluate benefit for the patient concerning recovery of natural erection. Patients with penile vascular abnormality (echo-doppler) and localized prostate cancer (considered as cured by radical prostatectomy) will be included in this study.
Four different doses of BMMNC will be tested.
Read the detailed description
We have shown in a rat model of post prostatectomy erectile dysfunction that BMMNC injection replace apoptotic cavernous cells and restore erectile function.
In the pig, the injection of high dose of BMMNC into the corpus cavernosus does not cause side effect. Moreover, the BMMNC remains at the injection site.
- Conditions
- Prostate Cancer, Erectile Dysfunction
- Being tested
- injection of bone marrow mononucleated cells
- Keywords
- radical prostatectomy
- Medical subject headings
- Prostatic Neoplasms, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of bone marrow mononucleated cellsBiological
Also called cell therapy
Four different concentration of BMMNC will be tested in four groups of 3 patients. In group 5 (n=19): one cell concentration corresponding to the best dose determined by analysis of the previous groups will be tested.
| Study group | Role | What they receive |
|---|---|---|
| injection of bone marrow cells | Experimental | Not described Receives: Biological: injection of bone marrow mononucleated cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of serious adverse event (general or local)
Side effects envisaged: priapism, local inflammation after cell injection
Measured: 6 months
Secondary outcomes (1)
Recovery of natural erection, improvement of penile doppler parameters
Evaluation of erectile recovery using validated quesitonnaires (IIEF15, EHS, UCLA-PCI)
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2012
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089387
- Sponsor's protocol ID
- BT06-07
- Other IDs
- 2008-A01248-47
- Acronym
- INSTIN
- Status last verified
- Apr 2011
- First submitted
- 17 Mar 2010
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yiou R, Hamidou L, Birebent B, Bitari D, Le Corvoisier P, Contremoulins I, Rodriguez AM, Augustin D, Roudot-Thoraval F, de la Taille A, Rouard H. Intracavernous Injections of Bone Marrow Mononucleated Cells for Postradical Prostatectomy Erectile Dysfunction: Final Results of the INSTIN Clinical Trial. Eur Urol Focus. 2017 Dec;3(6):643-645. doi: 10.1016/j.euf.2017.06.009. Epub 2017 Jun 24.
PubMed 28753830Yiou R, Hamidou L, Birebent B, Bitari D, Lecorvoisier P, Contremoulins I, Khodari M, Rodriguez AM, Augustin D, Roudot-Thoraval F, de la Taille A, Rouard H. Safety of Intracavernous Bone Marrow-Mononuclear Cells for Postradical Prostatectomy Erectile Dysfunction: An Open Dose-Escalation Pilot Study. Eur Urol. 2016 Jun;69(6):988-91. doi: 10.1016/j.eururo.2015.09.026. Epub 2015 Oct 4.
PubMed 26439886Khera 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 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracavernous Bone Marrow Stem-cell Injection for Post Prostatectomy Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT01089387
- Acronym / sponsor ID
- INSTIN / BT06-07
- Conditions
- Prostate Cancer, Erectile Dysfunction
- Keywords
- radical prostatectomy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- May 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 18 Mar 2010 (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.
Erectile dysfunction is a frequent adverse event after radical prostatectomy for prostate cancer.
It is the consequence of penile vascular damage, mainly arterial insufficiency and venous leakage associated with fibrosis of the corpus cavernous. Apoptosis of penile cells, including mesenchymal cells, smooth muscle cells and endothelial is believed to play an important role in the pathophysiology of post prostatectomy erectile dysfunction.
Bone marrow mononucleated cells (BMMNC) contain different cell types that may replace the damaged penile cells after radical prostatectomy. These are mainly: mesenchymal stem cells, endothelial progenitor cells and hematopoietic stem cell. Intracavernous injection of BMMNC may therefore find application in the treatment of post prostatectomy erectile dysfunction.
The aims of this phase I-II study is to test the safety of autologous intracavernous BMMNC injection and to evaluate benefit for the patient concerning recovery of natural erection. Patients with penile vascular abnormality (echo-doppler) and localized prostate cancer (considered as cured by radical prostatectomy) will be included in this study.
Four different doses of BMMNC will be tested.
Detailed description
We have shown in a rat model of post prostatectomy erectile dysfunction that BMMNC injection replace apoptotic cavernous cells and restore erectile function.
In the pig, the injection of high dose of BMMNC into the corpus cavernosus does not cause side effect. Moreover, the BMMNC remains at the injection site.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| injection of bone marrow cells | Experimental | Biological: injection of bone marrow mononucleated cells |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Localized prostate cancer: PSA (Prostate Specific Antigen) prior to radical prostatectomy < 10 ng/ml, histopathologic analysis of the prostate showing a prostate cancer with Gleason score ≤ 7, negative margin, absence of effraction of the prostatic capsule, pT1 or pT2 N0 or NX.
- PSA=0 ng/ml 6 months after radical prostatectomy.
- Normal erectile function prior to radical prostatectomy.
- Penile arterial insufficiency and or venous leakage (doppler) at the time of inclusion: PSV <25 cm/sec, PSV >25 cm/sec, EDV>5cm/sec, RI<0,75.
Key exclusion criteria (1 listed)
- Non localized prostate cancer.
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 |
|---|---|---|
| injection of bone marrow mononucleated cellsAlso: cell therapyFour different concentration of BMMNC will be tested in four groups of 3 patients. In group 5 (n=19): one cell concentration corresponding to the best dose determined by analysis of the previous groups will be tested. | Biological | injection of bone marrow cells |
Primary outcome
Absence of serious adverse event (general or local)
Time frame: 6 months
Side effects envisaged: priapism, local inflammation after cell injection
1 secondary outcome
Recovery of natural erection, improvement of penile doppler parameters
Time frame: 6 month
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 4 Dec 2025.
- Results publication: PubMed 28753830Yiou R, Hamidou L, Birebent B, Bitari D, Le Corvoisier P, Contremoulins I, Rodriguez AM, Augustin D, Roudot-Thoraval F, de la Taille A, Rouard H. Intracavernous Injections of Bone Marrow Mononucleated Cells for Postradical Prostatectomy Erectile Dysfunction: Final Results of the INSTIN Clinical Trial. Eur Urol Focus. 2017 Dec;3(6):643-645. doi: 10.1016/j.euf.2017.06.009. Epub 2017 Jun 24.
- Results publication: PubMed 26439886Yiou R, Hamidou L, Birebent B, Bitari D, Lecorvoisier P, Contremoulins I, Khodari M, Rodriguez AM, Augustin D, Roudot-Thoraval F, de la Taille A, Rouard H. Safety of Intracavernous Bone Marrow-Mononuclear Cells for Postradical Prostatectomy Erectile Dysfunction: An Open Dose-Escalation Pilot Study. Eur Urol. 2016 Jun;69(6):988-91. doi: 10.1016/j.eururo.2015.09.026. Epub 2015 Oct 4.
- 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 1/2 study testing injection of bone marrow mononucleated cells in people with Prostate Cancer and Erectile Dysfunction, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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 1 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 4 Dec 2025. 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 France. 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 combined 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.
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?
Absence of serious adverse event (general or local) (time frame: 6 months). 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 NCT01089387, which also lists 3 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 4 Dec 2025.