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

Urinary Incontinence Clinical Trial

— FLPURO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01799694
• Other study ID #: FLPURO-2009-01
• Secondary ID: 2009-016298-14
• Status: Completed
• Phase: Phase 2
• First received: September 4, 2012
• Last updated: March 7, 2013
• Start date: July 2011
• Est. completion date: February 2013

Study information

• Verified date: September 2012
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Urinary Incontinence

Intervention

Drug:
• Inject of Autologous Adipose-derived stem cells
Inject in muscle of autologous adipose derived stem cells

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

References & Publications (16)

Andriole GL, Grubb III LB, Buys SS et als. for the PLCO Project Team

Becker C, Jakse G. Stem cells for regeneration of urological structures. Eur Urol. 2007 May;51(5):1217-28. Epub 2007 Jan 18. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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]. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the feasibility and security of the autologous e-ASC for the urinary incontinence after a radical prostate cancer surgery	Possibility of inject ASc by cystoscope	16 weeks	No
Secondary	Quality of life assessment using the SF-12 Questionnaire	SF-12 questionnaire	1, 4, 16, 24 weeks	No
Secondary	Adverse events	Data collected	1, 4, 16, 24 weeks	Yes