Stromal Vascular Fraction (SVF) for Treatment of Recto-vaginal Fistula (HULPCIR)
This study is currently recruiting participants.
Verified March 2012 by Instituto de Investigación Hospital Universitario La Paz
Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier:
NCT01548092
First received: February 26, 2012
Last updated: March 5, 2012
Last verified: March 2012
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Purpose
The purpose of this study is to determine safety of Stromal Vascular Fraction (SVF) for the treatment of recto-vaginal fistula.
| Condition | Intervention | Phase |
|---|---|---|
|
Recto-vaginal Fistula |
Drug: Adipose-derived stem cells without expanded |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Instituto de Investigación Hospital Universitario La Paz:
Primary Outcome Measures:
- Safety of treatment of treated recto-vaginal fistulae. Percentage of treated enterocutaneous fistulae and percentage of subjects with closed fistulae [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]Safety by control the adverse effects associated with treatment Fistula close by 3D ultrasound
Secondary Outcome Measures:
- Quality of life assessment using the SF-12 Questionnaire [ Time Frame: 1, 4, 16, 24 weeks ] [ Designated as safety issue: No ]Test SF-12 of quality of life
- Adverse events [ Time Frame: 1, 4, 12, 24 weeks ] [ Designated as safety issue: Yes ]Control by investigation team of CRD (data collections)
| Estimated Enrollment: | 10 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Autologous SVF
Intralesional application
|
Drug: Adipose-derived stem cells without expanded
Administration will be intralesional injection of cells suspension. They will be placed into fistula walls
Other Name: Adipose-Derived Mesenchymal Stem Cells
|
Detailed Description:
SF-12 Test
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548092
Contacts
| Contact: Mariano Garcia Arranz | +34912071022 | mgarciaa.hulp@salud.madrid.org |
| Contact: Maria Dolores Herreos | +34912071022 | loles.herreros@gmail.com |
Locations
| Spain | |
| Hospital Universitario La Paz | Recruiting |
| Madrid, Spain, 28039 | |
| Contact: Mariano García Arranz +34912071022 mgarciaa.hulp@salud.madrid.org | |
| Principal Investigator: Maria Dolores Herreros | |
| Sub-Investigator: Damián García Olmo | |
| Sub-Investigator: Tihomir Hirstov | |
| Sub-Investigator: Héctor Guadalajara | |
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Investigators
| Principal Investigator: | Mariano García Arranz, PhD | Cell Therapy laboratory and general Surgery Department, Hospital Universitario La Paz |
More Information
Publications:
| Responsible Party: | Instituto de Investigación Hospital Universitario La Paz |
| ClinicalTrials.gov Identifier: | NCT01548092 History of Changes |
| Other Study ID Numbers: | EC10-343, 2010-024330-35 |
| Study First Received: | February 26, 2012 |
| Last Updated: | March 5, 2012 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Instituto de Investigación Hospital Universitario La Paz:
|
Recto-vaginal fistula Adipose Derived Stem Cells |
Additional relevant MeSH terms:
|
Fistula Rectovaginal Fistula Vaginal Fistula Pathological Conditions, Anatomical Rectal Fistula Intestinal Fistula Digestive System Fistula |
Digestive System Diseases Intestinal Diseases Gastrointestinal Diseases Rectal Diseases Vaginal Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 19, 2013