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

NCT01804153 | Unknown Phase 1

• 2 other identifiers: HULPURO-2010-012010-024331-16
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urinary Incontinence

Keywords

Feminine stress urinary incontinence; Autologous expanded stem cells

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Quality of life assessment using the SF-12 Questionnaire

  1, 4, 16, 24 weeks

• Adverse events

  1, 4, 16, 24 weeks

Study Arms (1)

Autologous expanded stem cells

EXPERIMENTAL

Adipose-derived expanded stem cells

Drug: Adipose-derived expanded stem cells

Interventions

Adipose-derived expanded stem cells DRUG

Intralesional application ASC

Autologous expanded stem cells

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consen
• Good general state of health according to the findings of ythe clinical history and the physical examination
• Postmenopausal or over 18 years old women taking highly effective contraceptives following the ICH (M3) EMA guide
• Women having rejected de rehabilitation treatment or in which the treatment had failed
• Genuine or combined stress urinary incontinence diagnosed with at least 1 year of evolution

You may not qualify if:

• Pregnant or lactating women
• Active urine infection
• Presenting an infravesical obstruction
• 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
• Cardiopulmonar illness that, in the investigator opinion, could be unstable or could be serious enough to drop the patient from the study
• Any kind of medical or psychiatric illness that, in the investigator opinion, could be a reason to exclude the patient from the study
• Anesthesic allergy
• Major surgery or severe trauma in the previous 6 months
• Administration of any drug under experimentation in the present or 3 months before recruitement

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

RECRUITING

Related Publications (19)

• 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.

  PMID: 11025769 BACKGROUND

• 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.

  PMID: 20541241 BACKGROUND

• 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.

  PMID: 17532554 BACKGROUND

• 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.

  PMID: 16904482 BACKGROUND

• 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.

  PMID: 14624934 BACKGROUND

• 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.

  PMID: 18019363 BACKGROUND

• 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.

  PMID: 17254699 BACKGROUND

• 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.

  PMID: 11304456 BACKGROUND

• 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.

  PMID: 21050657 BACKGROUND

• 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.

  PMID: 18639289 BACKGROUND

• 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.

  PMID: 19969332 BACKGROUND

• 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.

  PMID: 19878076 BACKGROUND

• 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.

  PMID: 18204978 BACKGROUND

• 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.

  PMID: 17683852 BACKGROUND

• 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.

  PMID: 17760890 BACKGROUND

• 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.

  PMID: 18001790 BACKGROUND

• 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.

  PMID: 19799652 BACKGROUND

• 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.

  PMID: 12756590 BACKGROUND

• 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.

  PMID: 19273960 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sergio Alonso Gregorio, MD

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariano García-Arranz, PhD

CONTACT

0034 912071022; mgarciaa.hulp@salud.madrid.org

Sergio Alonso Gregorio, MD

CONTACT

0034 912071022; garavelos@terra.es

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2012
• First Posted: March 5, 2013
• Study Start: September 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: April 1, 2014
• Last Updated: March 5, 2013

Record last verified: 2013-03

Locations

ES (1)