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Urinary IncontinencePhase 2FLPURONCT01799694

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

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Urinary Incontinence
What is being tested?
Inject of Autologous Adipose-derived stem cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSpain
Study dates
Jul 2011to Feb 2013
Phase
Phase 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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Men over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
  • Prostate cancer diagnosed subjects via a biopsy and having had a radical surgery with a healing purpose in the previous 18 months
  • Having urinary incontinence after the surgery
  • Failure in any previous conservative treatment

Who cannot join

  • Having had an adjuvant treatment
  • Having a PSA ≥ 0,2 after surgery
  • Having any sign or symptom that suggest the investigator the non-healing of the adenocarcinoma
  • Active urine infection
  • Alcohol or other addictive substances abuse antecedents in the previous 6 months to the inclusion
  • Cardiopulmonary 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 acquired immunodeficiencies, B and/or C Hepatitis, Tuberculose or Treponema diagnosed at the moment of inclusion
  • Anesthetic allergy
  • Major surgery or severe trauma in the previous 6 months
  • Administration of any drug under experimentation in the present or in the previous 3 months before recruitment

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046

Other trials in Spain

About this study

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

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

Being tested
Inject of Autologous Adipose-derived stem cells
Keywords
Urinary incontinence, Autologous expanded stem cells, Radical prostate cancer surgery
Medical subject headings
Urinary Incontinence

What participants receive

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

  • Inject of Autologous Adipose-derived stem cellsDrug

    Also called Autologuos eASC

    Inject in muscle of autologous adipose derived stem cells

Study groups in NCT01799694
Study groupRoleWhat they receive
Autologous Expanded Stem CellsExperimentalInject of Autologous Adipose-derived expanded stem cells
Receives: Drug: Inject of Autologous Adipose-derived stem cells

What is being measured

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

  1. 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

    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 collected

    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 posted27 Feb 2013 (estimated)
  2. Study startJul 2011
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01799694
Sponsor's protocol ID
FLPURO-2009-01
Other IDs
2009-016298-14, 2009
Acronym
FLPURO
Status last verified
Sep 2012
First submitted
4 Sep 2012
Last updated
8 Mar 2013
Results posted
No
Data monitoring committee
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

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

  • Schroder 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, Maattanen 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.

    PubMed 19297566

  • 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

  • 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

  • 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, 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.

    PubMed 18001790

  • 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

  • García Olmo D, García-Verdugo JM, Alemany J, Gonzalez M, Gutierrez-Fuentes JA. CELL THERAPHY . Ed. Mac Graw Hill. Madrid 2007

  • 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.

    PubMed 12756590

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Inject of Autologous Adipose-derived 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: finished, as of the sponsor's last update on 8 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 phase mean?

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the feasibility and security of the autologous e-ASC for the urinary incontinence after a radical prostate cancer surgery (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 NCT01799694, which also lists 16 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 8 Mar 2013.

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