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Urinary IncontinencePhase 1/2HULPURONCT01804153

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

A Phase 1/2 study testing Adipose-derived expanded stem cells in people with Urinary Incontinence, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Evaluate the feasability and security of the autologous ASC for the femenine stress urinary incontinence Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Urinary Incontinence
What is being tested?
Adipose-derived expanded stem cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSpain
Study dates
Sep 2012to Apr 2014
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -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

Who cannot join

  • -Pregnant or lactating women
  • -Active urine infection
  • -Presenting an infravesical obstruction
  • -Alcohol or other addictive substances abuse antecedents in the previous 6 months to the inclusion
  • -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
Show all 11Show fewer
  • -Any kind of medical or psychiatric illness that, in the investigator opinion, could be a reason to exclude the patient from the study
  • -Subjects with congenital or aquired inmunodeficiencies, B and/or C Hepatitis, Tuberculose or Treponema diagnosed at the moment of inclusion
  • -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

Trial locations and contacts

1 site in 1 country.

Mariano García-Arranz, PhD contact

0034 912071022

mgarciaa.hulp@salud.madrid.org

Sergio Alonso Gregorio, MD contact

0034 912071022

garavelos@terra.es

Spain1 site, 1 recruiting

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046

    Mariano García-Arranz, PhD, 0034 912071022, mgarciaa.hulp@salud.madrid.org

    Sergio Alonso Gregorio, MD

    Recruiting

Other trials in Spain

About this study

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

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

Read the detailed description

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

Being tested
Adipose-derived expanded stem cells
Keywords
Feminine stress urinary incontinence, Autologous expanded stem cells
Medical subject headings
Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adipose-derived expanded stem cellsDrug

    Intralesional application ASC

Study groups in NCT01804153
Study groupRoleWhat they receive
Autologous expanded stem cellsExperimentalAdipose-derived expanded stem cells
Receives: Drug: Adipose-derived expanded stem cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 16 weeks

Secondary outcomes (2)

  1. Quality of life assessment using the SF-12 Questionnaire

    SF-12 questionnaire

    Measured: 1, 4, 16, 24 weeks

  2. Adverse events

    Data collection

    Measured: 1, 4, 16, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2013 (estimated)
  2. Study startSep 2012
  3. Primary completionOct 2013 (estimated)
  4. Study completionApr 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01804153
Sponsor's protocol ID
HULPURO-2010-01
Other IDs
2010-024331-16
Acronym
HULPURO
Status last verified
Mar 2013
First submitted
4 Sep 2012
Last updated
5 Mar 2013
Results posted
No

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.

    PubMed 11025769

  • 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.

    PubMed 20541241

  • 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.

    PubMed 17532554

  • 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.

    PubMed 16904482

  • 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.

    PubMed 14624934

  • 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.

    PubMed 18019363

  • 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.

    PubMed 17254699

  • 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.

    PubMed 11304456

  • 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.

    PubMed 21050657

  • 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.

    PubMed 18639289

  • 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.

    PubMed 19969332

  • 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.

    PubMed 19878076

  • 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.

    PubMed 18204978

  • 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.

    PubMed 17683852

  • 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.

    PubMed 17760890

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Adipose-derived expanded stem cells in people with Urinary Incontinence, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mariano García-Arranz, PhD (0034 912071022, mgarciaa.hulp@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the feasability and security of the autologous ASC for the feminine stress urinary incontinence (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01804153, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2013.

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