Stem Cells Treatment for the Local Urinary Incontinence After a Radical Prostate Cancer Surgery (HULPURO) (FLPURO)

• ClinicalTrials.gov Identifier: NCT01799694
• Recruitment Status: Completed
• First Posted: February 27, 2013
• Last Update Posted: March 8, 2013
• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Information provided by (Responsible Party): Instituto de Investigación Hospital Universitario La Paz

Tracking Information

• First Submitted Date: September 4, 2012
• First Posted Date: February 27, 2013
• Last Update Posted Date: March 8, 2013
• Study Start Date: July 2011
• Actual Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 7, 2013)

Evaluate the feasibility and security of the autologous e-ASC for the urinary incontinence after a radical prostate cancer surgery [ Time Frame: 16 weeks ]

Possibility of inject ASc by cystoscope

Original Primary Outcome Measures (submitted: February 24, 2013)

Evaluate the feasability and security of the autologous e-ASC for the urinary incontinence after a radical prostate cancer surgery [ Time Frame: 16 weeks ]

Possibility of inject ASc by cystoscope

Current Secondary Outcome Measures (submitted: March 7, 2013)

• Quality of life assessment using the SF-12 Questionnaire [ Time Frame: 1, 4, 16, 24 weeks ]
  SF-12 questionnaire
• Adverse events [ Time Frame: 1, 4, 16, 24 weeks ]
  Data collected

Original Secondary Outcome Measures (submitted: February 24, 2013)

• Quality of life assessment using the SF-12 Questionnaire [ Time Frame: 1, 4, 16, 24 weeks ]
  SF-12 questionnare
• Adverse events [ Time Frame: 1, 4, 16, 24 weeks ]
  Data collecte

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Stem Cells Treatment for the Local Urinary Incontinence After a Radical Prostate Cancer Surgery (HULPURO)
• Official Title: 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
• Brief Summary: 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
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Urinary Incontinence

Intervention

Drug: Inject of Autologous Adipose-derived stem cells

Inject in muscle of autologous adipose derived stem cells

Other Name: Autologuos eASC

Study Arms

Experimental: Autologous Expanded Stem Cells

Inject of Autologous Adipose-derived expanded stem cells

Intervention: Drug: Inject of Autologous Adipose-derived stem cells

Publications *

• Strasser 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.
• Andriole GL, Grubb III LB, Buys SS et als. for the PLCO Project Team
• Schröder 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, Määttänen 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.
• Mitterberger 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. Epub 2007 May 22. Erratum in: Eur Urol. 2008 Nov;54(5):1208. Bartsch, Georg [removed].
• Kwon 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.
• Cannon 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.
• Praud C, Sebe P, Biérinx AS, Sebille A. Improvement of urethral sphincter deficiency in female rats following autologous skeletal muscle myoblasts grafting. Cell Transplant. 2007;16(7):741-9.
• Becker C, Jakse G. Stem cells for regeneration of urological structures. Eur Urol. 2007 May;51(5):1217-28. Epub 2007 Jan 18. Review.
• Zuk PA, Zhu M, Mizuno H, Huang J, Futrell JW, Katz AJ, Benhaim P, Lorenz HP, Hedrick MH. Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng. 2001 Apr;7(2):211-28.
• Kajbafzadeh AM, Elmi A, Payabvash S, Salmasi AH, Saeedi P, Mohamadkhani A, Sadeghi Z, Nikfarjam L. Transurethral autologous myoblast injection for treatment of urinary incontinence in children with classic bladder exstrophy. J Urol. 2008 Sep;180(3):1098-105. doi: 10.1016/j.juro.2008.05.057. Epub 2008 Jul 18.
• Carr LK, Steele D, Steele S, Wagner D, Pruchnic R, Jankowski R, Erickson J, Huard J, Chancellor MB. 1-year follow-up of autologous muscle-derived stem cell injection pilot study to treat stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Jun;19(6):881-3. doi: 10.1007/s00192-007-0553-z.
• Mitterberger M, Marksteiner R, Margreiter E, Pinggera GM, Frauscher F, Ulmer H, Fussenegger M, Bartsch G, Strasser H. Myoblast and fibroblast therapy for post-prostatectomy urinary incontinence: 1-year followup of 63 patients. J Urol. 2008 Jan;179(1):226-31. Epub 2007 Nov 14.
• Mitterberger M, Pinggera GM, Marksteiner R, Margreiter E, Fussenegger M, Frauscher F, Ulmer H, Hering S, Bartsch G, Strasser H. Adult stem cell therapy of female stress urinary incontinence. Eur Urol. 2008 Jan;53(1):169-75. Epub 2007 Jul 23.
• García Olmo D, García-Verdugo JM, Alemany J, Gonzalez M, Gutierrez-Fuentes JA. CELL THERAPHY . Ed. Mac Graw Hill. Madrid 2007
• García-Olmo D, García-Arranz M, García LG, Cuellar ES, Blanco IF, Prianes LA, Montes JA, Pinto FL, Marcos DH, García-Sancho L. Autologous stem cell transplantation for treatment of rectovaginal fistula in perianal Crohn's disease: a new cell-based therapy. Int J Colorectal Dis. 2003 Sep;18(5):451-4. Epub 2003 May 20.
• Garcia-Olmo D, Herreros D, Pascual I, Pascual JA, Del-Valle E, Zorrilla J, De-La-Quintana P, Garcia-Arranz M, Pascual M. Expanded adipose-derived stem cells for the treatment of complex perianal fistula: a phase II clinical trial. Dis Colon Rectum. 2009 Jan;52(1):79-86. doi: 10.1007/DCR.0b013e3181973487.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 24, 2013): 10
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: February 2013
• Actual Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT01799694
• Other Study ID Numbers: FLPURO-2009-01; 2009-016298-14 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Instituto de Investigación Hospital Universitario La Paz
• Study Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sergio Alonso Gregorio, MD; Cell Therapy laboratory and general Surgery Department, Hospital Universitario La Paz

• PRS Account: Instituto de Investigación Hospital Universitario La Paz
• Verification Date: September 2012