Clinical trial · Interventional
Intracavernous Bone Marrow Stem-cell Injection for Post Prostatectomy Erectile Dysfunction
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Erectile Dysfunction | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| injection of bone marrow mononucleated cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- injection of bone marrow cells
- interventionNames
- Biological: injection of bone marrow mononucleated cells
Primary outcomes (1)
- measure
- Absence of serious adverse event (general or local)
- timeFrame
- 6 months
- description
- Side effects envisaged: priapism, local inflammation after cell injection
Secondary outcomes (1)
- measure
- Recovery of natural erection, improvement of penile doppler parameters
- timeFrame
- 6 month
- description
- Evaluation of erectile recovery using validated quesitonnaires (IIEF15, EHS, UCLA-PCI)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Non localized prostate cancer.
References
Publications (3)
- RESULTYiou 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. PMID 28753830
- RESULTYiou 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. PMID 26439886
- DERIVEDKhera 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. PMID 25974235