Clinical trial · Interventional
Stem Cells Treatment for the Local Urinary Incontinence After a Radical Prostate Cancer Surgery (HULPURO)
Phase II Clinical Trial to Study the Feasibility and Safety of the Expanded Autologous Stem Cells Use Derived From Adipose Tissue (e-ASC) for the Local Urinary Incontinence After a Radical Prostate Cancer Surgery
NCT01799694CI-TRIAL-00009674FLPUROcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to evaluate the feasibility and security of the autologous e-ASC for the urinary incontinence after a radical prostate cancer surgery
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urinary Incontinence | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inject of Autologous Adipose-derived stem cells | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autologous Expanded Stem Cells
- description
- Inject of Autologous Adipose-derived expanded stem cells
- interventionNames
- Drug: Inject of Autologous Adipose-derived stem cells
Primary outcomes (1)
- measure
- Evaluate the feasibility and security of the autologous e-ASC for the urinary incontinence after a radical prostate cancer surgery
- timeFrame
- 16 weeks
- description
- Possibility of inject ASc by cystoscope
Secondary outcomes (2)
- measure
- Quality of life assessment using the SF-12 Questionnaire
- timeFrame
- 1, 4, 16, 24 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed informed consent 2. Men over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination 3. Prostate cancer diagnosed subjects via a biopsy and having had a radical surgery with a healing purpose in the previous 18 months 4. Having urinary incontinence after the surgery 5. Failure in any previous conservative treatment Exclusion Criteria: 1. Having had an adjuvant treatment 2. Having a PSA ≥ 0,2 after surgery 3. Having any sign or symptom that suggest the investigator the non-healing of the adenocarcinoma 4. Active urine infection 5. Alcohol or other addictive substances abuse antecedents in the previous 6 months to the inclusion 6. Cardiopulmonary illness that, in the investigator opinion, could be unstable or could be serious enough to drop the patient from the study 7. Any kind of medical or psychiatric illness that, in the investigator opinion, could be a reason to exclude the patient from the study 8. Subjects with congenital or acquired immunodeficiencies, B and/or C Hepatitis, Tuberculose or Treponema diagnosed at the moment of inclusion 9. Anesthetic allergy 10. Major surgery or severe trauma in the previous 6 months 11. Administration of any drug under experimentation in the present or in the previous 3 months before recruitment
References
Publications (16)
- BACKGROUNDStrasser H, Tiefenthaler M, Steinlechner M, Eder I, Bartsch G, Konwalinka G. Age dependent apoptosis and loss of rhabdosphincter cells. J Urol. 2000 Nov;164(5):1781-5. PMID 11025769
- BACKGROUNDAndriole GL, Grubb III LB, Buys SS et als. for the PLCO Project Team
- BACKGROUNDSchroder FH, Hugosson J, Roobol MJ, Tammela TL, Ciatto S, Nelen V, Kwiatkowski M, Lujan M, Lilja H, Zappa M, Denis LJ, Recker F, Berenguer A, Maattanen L, Bangma CH, Aus G, Villers A, Rebillard X, van der Kwast T, Blijenberg BG, Moss SM, de Koning HJ, Auvinen A; ERSPC Investigators. Screening and prostate-cancer mortality in a randomized European study. N Engl J Med. 2009 Mar 26;360(13):1320-8. doi: 10.1056/NEJMoa0810084. Epub 2009 Mar 18. PMID 19297566
- BACKGROUNDMitterberger M, Pinggera GM, Marksteiner R, Margreiter E, Plattner R, Klima G, Strasser H. Functional and histological changes after myoblast injections in the porcine rhabdosphincter. Eur Urol. 2007 Dec;52(6):1736-43. doi: 10.1016/j.eururo.2007.05.007. Epub 2007 May 22. PMID 17532554
- BACKGROUNDKwon D, Kim Y, Pruchnic R, Jankowski R, Usiene I, de Miguel F, Huard J, Chancellor MB. Periurethral cellular injection: comparison of muscle-derived progenitor cells and fibroblasts with regard to efficacy and tissue contractility in an animal model of stress urinary incontinence. Urology. 2006 Aug;68(2):449-54. doi: 10.1016/j.urology.2006.03.040. PMID 16904482
- BACKGROUNDCannon TW, Lee JY, Somogyi G, Pruchnic R, Smith CP, Huard J, Chancellor MB. Improved sphincter contractility after allogenic muscle-derived progenitor cell injection into the denervated rat urethra. Urology. 2003 Nov;62(5):958-63. doi: 10.1016/s0090-4295(03)00679-4. PMID 14624934
- BACKGROUNDPraud C, Sebe P, Bierinx AS, Sebille A. Improvement of urethral sphincter deficiency in female rats following autologous skeletal muscle myoblasts grafting. Cell Transplant. 2007;16(7):741-9. doi: 10.3727/000000007783465118.