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Allogenic Stem Cells Derived From Lipoaspirates for the Treatment of Recto-vaginal Fistulas Associated to Crohn`s Disease (ALOREVA) (ALOREVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00999115
Recruitment Status : Completed
First Posted : October 21, 2009
Last Update Posted : January 26, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine safety and efficacy of allogenic eASCs (expanded adult stem cells) for the treatment of recto-vaginal fistula in patients with Crohn´s disease.

Condition or disease Intervention/treatment Phase
Rectovaginal Fistula Crohn Disease Drug: Expanded allogenic adipose-derived adult stem cells Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial in Phase I-IIa to Study the Feasibility and Security of the Allogenic Use of Adipose-derived Stem Cells for the Local Treatment of Recto-vaginal Fistula in Crohn´s Disease
Study Start Date : September 2009
Primary Completion Date : December 2010
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Allogenic ASCs
Intralesional dose of 20 million cells at baseline with a possible second administration of 40 million in case of incomplete fistula closure following week 12 assessment.
Drug: Expanded allogenic adipose-derived adult stem cells
Administration will be preceded by localization and closure of the internal opening. Cell treatment injection will be performed following Major Ambulatory Surgery standards. Patients will receive an intralesional dose of 20 million cells at baseline. 50% of the cell suspension will be placed into fistula walls of the internal opening, with the remaining 50% being injected across the wall tracts of the target fistula. Patients without healing (complete fistula closure)at week 12 will receive a second dose of 40 million cells, using the same treatment approach.
Other Name: CX601 (company code)

Outcome Measures

Primary Outcome Measures :
  1. Percentage of subjects in whom the external openings of the treated rectovaginal fistula have closed [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Quality of life assessment using the SF-36 questionnaire [ Time Frame: 12 weeks ]
  2. Adverse events [ Time Frame: 1, 4, 8,12, 24, 54 weeks ]
  3. Clinically relevant variations in laboratory test [ Time Frame: 1, 4 8, 12, 24, 54 weeks ]
  4. Quality of life assessment using the SF-36 questionnaire [ Time Frame: 24 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed informed consent.
  • Patients with Crohn´s disease diagnosed at least 12 months earlier in accordance with accepted clinical, endoscopic, anatomopathological and/or radiologic criteria.
  • Fulfilling one of the following criteria:

    • At least, one previous surgery for fistulous disease.
    • Physical status which discourage liposuction.
  • Rectovaginal fistula.
  • Women of a childbearing age. Good general state of health according to the findings of the clinical history and the physical examination.

Exclusion Criteria:

  • Presence of severe proctitis (prominent friability, spontaneous bleeding, multiple erosions, deep ulcers) or dominant active luminal disease requiring immediate therapy, assessed by rectosigmoidoscopy
  • Patients with CDAI≥201
  • 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 who have received infliximab or any other anti TNF agent in the 8 weeks before the cell treatment administration
  • Patients who have received tacrolimus or cyclosporine in the 4 weeks before the cell treatment administration
  • 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, HBV, HCV or treponema infection, whether active or latent.
  • Patients allergic to local anesthetics or gadolinium (MRI contrast) MRI is unfeasible (e.g. due to the presence of pacemakers, hip replacements or severe claustrophobia)
  • 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 enrolment into this clinical trial, any investigational drug.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00999115

Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Principal Investigator: Damián García Olmo, MD General Surgery Department, Hospital Universitario La Paz
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ignacio Galicia, Professor, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
ClinicalTrials.gov Identifier: NCT00999115     History of Changes
Other Study ID Numbers: EC08/00153
EudraCT: 2009-010225-39
First Posted: October 21, 2009    Key Record Dates
Last Update Posted: January 26, 2012
Last Verified: January 2012

Keywords provided by Ignacio Galicia, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz:
Rectovaginal Fistula
Crohn Disease
Adipose-Derived Stem Cells

Additional relevant MeSH terms:
Crohn Disease
Vaginal Fistula
Rectovaginal Fistula
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Vaginal Diseases
Genital Diseases, Female
Rectal Fistula
Intestinal Fistula
Digestive System Fistula
Rectal Diseases