Clinical trial NCT01804153: Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Urinary Incontinence
Keywords: Feminine stress urinary incontinence
Autologous expanded stem cells
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2013-03-05
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the feasability and security of the autologous ASC for the feminine stress urinary incontinence
timeFrame: 16 weeks
Secondary outcomes:
measure: Quality of life assessment using the SF-12 Questionnaire
timeFrame: 1, 4, 16, 24 weeks
measure: Adverse events
timeFrame: 1, 4, 16, 24 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Hospital Universitario La Paz
name: Sergio Alonso Gregorio, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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. doi: 10.1016/j.eururo.2007.05.007. Epub 2007 May 22.
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. doi: 10.1016/j.urology.2006.03.040.
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. doi: 10.1016/s0090-4295(03)00679-4.
citation: Praud 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.
citation: Becker C, Jakse G. Stem cells for regeneration of urological structures. Eur Urol. 2007 May;51(5):1217-28. doi: 10.1016/j.eururo.2007.01.029. Epub 2007 Jan 18.
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. doi: 10.1089/107632701300062859.
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.
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.
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.
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.
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.
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. doi: 10.1016/j.eururo.2007.07.026. Epub 2007 Jul 23.
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. doi: 10.1111/j.1464-410X.2007.07119.x. Epub 2007 Aug 30.
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. doi: 10.1016/j.juro.2007.08.154. Epub 2007 Nov 14.
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.
citation: Garcia-Olmo D, Garcia-Arranz M, Garcia LG, Cuellar ES, Blanco IF, Prianes LA, Montes JA, Pinto FL, Marcos DH, Garcia-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. doi: 10.1007/s00384-003-0490-3. Epub 2003 May 20.
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.