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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ignacio Galicia, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
ClinicalTrials.gov Identifier:
NCT00999115
First received: October 20, 2009
Last updated: January 25, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Rectovaginal Fistula
Crohn Disease
Drug: Expanded allogenic adipose-derived adult stem cells
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: 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

Resource links provided by NLM:


Further study details as provided by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz:

Primary Outcome Measures:
  • Percentage of subjects in whom the external openings of the treated rectovaginal fistula have closed [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life assessment using the SF-36 questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 1, 4, 8,12, 24, 54 weeks ] [ Designated as safety issue: Yes ]
  • Clinically relevant variations in laboratory test [ Time Frame: 1, 4 8, 12, 24, 54 weeks ] [ Designated as safety issue: Yes ]
  • Quality of life assessment using the SF-36 questionnaire [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: September 2009
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00999115

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

Publications:
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
Study First Received: October 20, 2009
Last Updated: January 25, 2012
Health Authority: Spain: Spanish Agency of Medicines

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

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

ClinicalTrials.gov processed this record on April 17, 2014