Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO)

Urinary Incontinence Clinical Trial

— HULPURO  

Official title:

Phase II Clinical Trial to Study the Feasibility and Safety of the Expanded Autologous Mesenchymal Stem Cells Use Derived From Adipose Tissue (ASC) for the Local Feminine Stress Urinary Incontinence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01804153
• Other study ID #: HULPURO-2010-01
• Secondary ID: 2010-024331-16
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: September 4, 2012
• Last updated: March 1, 2013
• Start date: September 2012
• Est. completion date: April 2014

Study information

• Verified date: March 2013
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: Mariano García-Arranz, PhD
• Phone: 0034 912071022
• Email: mgarciaa.hulp[@]salud.madrid.org
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

Evaluate the feasability and security of the autologous ASC for the femenine stress urinary incontinence

Description:

Evaluate safety of adipose derived stem cells to femenine urinary incontinence with local application

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. -Signed informed consen

2. -Good general state of health according to the findings of ythe clinical history and the physical examination

3. -Postmenopausal or over 18 years old women taking highly effective contraceptives following the ICH (M3) EMA guide

4. -Women having rejected de rehabilitation treatment or in which the treatment had failed

5. -Genuine or combined stress urinary incontinence diagnosed with at least 1 year of evolution

Exclusion Criteria:

1. -Pregnant or lactating women

2. -Active urine infection

3. -Presenting an infravesical obstruction

4. -Alcohol or other addictive substances abuse antecedents in the previous 6 months to the inclusion

5. -Presenting any other malignant neoplasia unless it is a basocellar or a skin epidermoide carcinoma or presents antecedents of malignant tumours, unless they are in a remission phase for the previous 5 years

6. -Cardiopulmonar 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 aquired inmunodeficiencies, B and/or C Hepatitis, Tuberculose or Treponema diagnosed at the moment of inclusion

9. -Anesthesic allergy

10. -Major surgery or severe trauma in the previous 6 months

11. -Administration of any drug under experimentation in the present or 3 months before recruitement

Study Design

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

Related Conditions & MeSH terms

• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Drug:
• Adipose-derived expanded stem cells
Intralesional application ASC

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 (19)

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

Buckley BS, Lapitan MC; Epidemiology Committee of the Fourth International Consultation on Incontinence, Paris, 2008. Prevalence of urinary incontinence in men, women, and children--current evidence: findings of the Fourth International Consultation on Incontinence. Urology. 2010 Aug;76(2):265-70. doi: 10.1016/j.urology.2009.11.078. Epub 2010 Jun 11. — 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

Fu Q, Song XF, Liao GL, Deng CL, Cui L. Myoblasts differentiated from adipose-derived stem cells to treat stress urinary incontinence. Urology. 2010 Mar;75(3):718-23. doi: 10.1016/j.urology.2009.10.003. Epub 2009 Dec 6. — View Citation

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

Lin G, Wang G, Banie L, Ning H, Shindel AW, Fandel TM, Lue TF, Lin CS. Treatment of stress urinary incontinence with adipose tissue-derived stem cells. Cytotherapy. 2010;12(1):88-95. doi: 10.3109/14653240903350265. — View Citation

Mitterberger M, Marksteiner R, Margreiter E, Pinggera GM, Colleselli D, Frauscher F, Ulmer H, Fussenegger M, Bartsch G, Strasser H. Autologous myoblasts and fibroblasts for female stress incontinence: a 1-year follow-up in 123 patients. BJU Int. 2007 Nov;100(5):1081-5. Epub 2007 Aug 30. — 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

Roche R, Festy F, Fritel X. Stem cells for stress urinary incontinence: the adipose promise. J Cell Mol Med. 2010 Jan;14(1-2):135-42. doi: 10.1111/j.1582-4934.2009.00915.x. Epub 2009 Oct 3. Review. — 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

Zhao W, Zhang C, Jin C, Zhang Z, Kong D, Xu W, Xiu Y. Periurethral injection of autologous adipose-derived stem cells with controlled-release nerve growth factor for the treatment of stress urinary incontinence in a rat model. Eur Urol. 2011 Jan;59(1):155-63. doi: 10.1016/j.eururo.2010.10.038. Epub 2010 Oct 26. — 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 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the feasability and security of the autologous ASC for the feminine stress urinary incontinence	compress test (number dthe changes daily) urethrocystoscopy (morphology of urethra)	16 weeks	No
Secondary	Quality of life assessment using the SF-12 Questionnaire	SF-12 questionnaire	1, 4, 16, 24 weeks	Yes
Secondary	Adverse events	Data collection	1, 4, 16, 24 weeks	Yes