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Recto-vaginal FistulaPhase 1/2HULPCIRNCT01548092

Stromal Vascular Fraction (SVF) for Treatment of Recto-vaginal Fistula

A Phase 1/2 study testing Adipose-derived stem cells without expanded in people with Recto-vaginal Fistula, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study is to determine safety of Stromal Vascular Fraction (SVF) for the treatment of recto-vaginal fistula. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recto-vaginal Fistula
What is being tested?
Adipose-derived stem cells without expanded
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSpain
Study dates
Dec 2011to Dec 2013
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Recto-vaginal fistula
  • Men and women over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
  • Crohn's disease diagnosed at least 3 months before accepting the clinical criteria

Who cannot join

  • Presence of severe proctitis or dominant active luminal disease requiring immediately therapy
  • Patients with an abscess unless a complete toilet of the area with drainage of the collections and the absence of abscess and other collections is confirmed prior to treatment start
  • Patients with a history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion
  • Patients with malignant tumor, except for basal cell or cutaneous squamous cell carcinoma, or patients with a prior history of malignant tumors, unless the neoplastic disease has been in remission for the previous 5 years
  • Patients with cardiopulmonary disease which, in opinion of the investigator, in unstable or sufficiently serious to exclude the patient from the study.
  • Patients with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from study
Show all 11Show fewer
  • Patients with congenital or acquired immunodeficiencies. HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) or treponema infection, whether active or latent
  • Patients who have suffering major surgery or severe trauma in the prior 6 months
  • Pregnant or breastfeeding women
  • Patients currently receiving, or having received within 1 month prior to enrollment into this clinical trial, any investigational drug.
  • Crohns Disease Activity Index (CDAI) Index above 200

Trial locations and contacts

1 site in 1 country.

Mariano Garcia Arranz contact

+34912071022

mgarciaa.hulp@salud.madrid.org

Maria Dolores Herreos contact

+34912071022

loles.herreros@gmail.com

Spain1 site, 1 recruiting

  • Hospital Universitario La Paz

    Madrid, Madrid, 28039

    Mariano García Arranz, +34912071022, mgarciaa.hulp@salud.madrid.org

    Maria Dolores Herreros

    Recruiting

Other trials in Spain

About this study

Official title: A Phase II Clinical Trial to Study the Feasibility and Safety of Stromal Vascular Derived From Adipose Tissue for the Treatment of Recto-vaginal Fistula

The purpose of this study is to determine safety of Stromal Vascular Fraction (SVF) for the treatment of recto-vaginal fistula.

Read the detailed description

SF-12 Test

Being tested
Adipose-derived stem cells without expanded
Keywords
Recto-vaginal fistula, Adipose Derived Stem Cells
Medical subject headings
Rectovaginal Fistula

What participants receive

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

  • Adipose-derived stem cells without expandedDrug

    Also called Adipose-Derived Mesenchymal Stem Cells

    Administration will be intralesional injection of cells suspension. They will be placed into fistula walls

Study groups in NCT01548092
Study groupRoleWhat they receive
Autologous SVFExperimentalIntralesional application
Receives: Drug: Adipose-derived stem cells without expanded

What is being measured

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

  1. Safety of treatment of treated recto-vaginal fistulae. Percentage of treated enterocutaneous fistulae and percentage of subjects with closed fistulae

    Safety by control the adverse effects associated with treatment Fistula close by 3D ultrasound

    Measured: 16 weeks

Secondary outcomes (2)

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

    Test SF-12 of quality of life

    Measured: 1, 4, 16, 24 weeks

  2. Adverse events

    Control by investigation team of CRD (data collections)

    Measured: 1, 4, 12, 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 posted8 Mar 2012 (estimated)
  2. Study startDec 2011
  3. Primary completionJul 2012 (estimated)
  4. Study completionDec 2013 (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
NCT01548092
Sponsor's protocol ID
EC10-343
Other IDs
2010-024330-35
Acronym
HULPCIR
Status last verified
Mar 2012
First submitted
26 Feb 2012
Last updated
8 Mar 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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

  • Garcia-Olmo D, Garcia-Arranz M, Herreros D, Pascual I, Peiro C, Rodriguez-Montes JA. A phase I clinical trial of the treatment of Crohn's fistula by adipose mesenchymal stem cell transplantation. Dis Colon Rectum. 2005 Jul;48(7):1416-23. doi: 10.1007/s10350-005-0052-6.

    PubMed 15933795

  • Herreros Marcos D, Garcia-Arranz M,Pascual Miguelañez I, Garcia-Olmo D. THE ROLE OF STEM CELLS IN SUPPURATIVE ENVIROMENTS. Experimental Dermatology 2006, 15 (6): 482

  • Garcia-Olmo D, Herreros D, Pascual M, Pascual I, De-La-Quintana P, Trebol J, Garcia-Arranz M. Treatment of enterocutaneous fistula in Crohn's Disease with adipose-derived stem cells: a comparison of protocols with and without cell expansion. Int J Colorectal Dis. 2009 Jan;24(1):27-30. doi: 10.1007/s00384-008-0559-0. Epub 2008 Aug 12.

    PubMed 18696086

  • Alvarez PD, Garcia-Arranz M, Georgiev-Hristov T, Garcia-Olmo D. A new bronchoscopic treatment of tracheomediastinal fistula using autologous adipose-derived stem cells. Thorax. 2008 Apr;63(4):374-6. doi: 10.1136/thx.2007.083857.

    PubMed 18364447

  • Vilalta M, Degano IR, Bago J, Gould D, Santos M, Garcia-Arranz M, Ayats R, Fuster C, Chernajovsky Y, Garcia-Olmo D, Rubio N, Blanco J. Biodistribution, long-term survival, and safety of human adipose tissue-derived mesenchymal stem cells transplanted in nude mice by high sensitivity non-invasive bioluminescence imaging. Stem Cells Dev. 2008 Oct;17(5):993-1003. doi: 10.1089/scd.2007.0201.

    PubMed 18537463

  • 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.

    PubMed 19273960

  • Pascual I, de Miguel GF, Gomez-Pinedo UA, de Miguel F, Arranz MG, Garcia-Olmo D. Adipose-derived mesenchymal stem cells in biosutures do not improve healing of experimental colonic anastomoses. Br J Surg. 2008 Sep;95(9):1180-4. doi: 10.1002/bjs.6242.

    PubMed 18690635

  • García Olmo D, Trébol J, Herreros D, Garcia-Arranz M, Gonzalez M. TREATMENT OF FISTULAS USING ADIPOSE-DERIVED STEM CELLS. En: 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, Herreros D. Expanded adipose-derived stem cells for the treatment of complex perianal fistula including Crohn's disease. Expert Opin Biol Ther. 2008 Sep;8(9):1417-23. doi: 10.1517/14712598.8.9.1417.

    PubMed 18694359

  • Garcia-Olmo, D; Guadalajara, H; Trebol, J, García-Arranz M. Expanded Adipose-Derived Stem Cells for the Treatment of Complex Perianal Fistula. HUMAN GENE THERAPY 2009. 20 (9):1028-1028

  • Trebol, J; Garcia-Arranz, M; Georgiev-Hristov, T, et al. Cell Therapy for Enterocutaneous Fistula Associated with Crohn's Disease: A Clinical and Biological Comparison of Protocols With and Without Cell Expansion. HUMAN GENE THERAPY 2009. 20 (9): 1045-1045

  • Garcia-Gomez, I; Olmedillas, S; Garcia-Arranz, M, et al. Adipose-Derived Stem Cells Reduce Abdominal Adhesion Formation in a Rat Experimental Model. HUMAN GENE THERAPY 2009. 20 (9): 1047-1047

  • Georgiev-Hristov, T; Garcia-Olmo, D; Alvarez, PDA, et al. Use of Surgical Sutures Enriched with Adipose-Derived Stem Cells for Tracheal Anastomosis in Rats. HUMAN GENE THERAPY 2009. 20 (9): 1074-1075

  • Vicente, A; Vazquez, MN; Entrena, A, Gqarcía-Arranz M,et al. BMP-4 Regulates the Expansion and Survival of Human Adipose Mesenchymal Cells. HUMAN GENE THERAPY .2009. 20 (9):1080-1081

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Adipose-derived stem cells without expanded in people with Recto-vaginal Fistula, 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 4 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 8 Mar 2012. 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 Garcia Arranz (+34912071022, 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?

Safety of treatment of treated recto-vaginal fistulae. Percentage of treated enterocutaneous fistulae and percentage of subjects with closed fistulae (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 NCT01548092, which also lists 20 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 2012.

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