Treatment of Fistulous Crohn's Disease by Implant of Autologous Mesenchymal Stem Cells Derived From Adipose Tissue

November 7, 2016 updated by: Clinica Universidad de Navarra, Universidad de Navarra

Primary outcome measure:

Evaluation of viability, security and tolerance of the adipose-derived mesenchymal stem cells implant (ASCs) in fistulizing Crohn's disease patients, collecting the reactions and adverse events occurred during the study.

Secondary outcome measures:

  1. Evaluating the Adipose-derived mesenchymal stem cells therapeutic effect, in particular:

    • Fistulas healing efficiency
    • Changes in quality of life in patients treated
    • Changes of systemic Crohn's disease after implant
    • Relapse rate monitored among patients who achieved Adipose-derived mesenchymal Stem Cells treatment success.

  2. Achieving the biological characterization of the cell product used and its correlation with the therapeutic effect measured with:

    • Phenotype study
    • Suppressor capacity study.
    • Citoquines production analysis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to evaluate the role of Autologous Mesechymal Stem Cells derived from adipose tissue in the treatment of fistulous Crohn disease.

15 Crohn's disease patients with one or more enterocutaneous, recto-vaginal or complex perianal fistula, will be included.

The trial is divided in three phases:

I. - Selection: Patients evaluation for study eligibility will take place within two weeks after Informed Consent signature.

Fistulous disease will be evaluated by MRI for perianal and rectovaginal fistulas, and by CT scan in the case of enterocutaneous fistula.

Previous laboratory test and radiological studies are valid for evaluation if they were obtained within two and six months, respectively, prior to this evaluation, and in the absence of clinical changes.

II.- Treatment phase includes:

  1. Liposuction procedure to obtain adipose tissue.
  2. Processing and production of Autologous Mesenchymal Stem Cells from adipose tissue (ASCs)
  3. ASCs implant

III.- Follow up: Study visits post-implant will take place at the 1st week (+/- 3 days), 4th week (+/- 3 days), 8th week (+/- 7 days), 12nd week (+/- 7 days), 24th week (+/- 7 days), and 1 year (+/- 7 days) after implant.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Pamplona, Spain, 31008
        • Clinica Universitaria de Navarra
      • Pamplona, Spain, 31008
        • Hospital Virgen del Camino
      • Pamplona, Spain, 31008
        • Hospital Provincial de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Fistulizing Crohn´s disease patients with 1 or more enterocutaneous fistulas, recto-vaginal fistula or complex perianal fistula. The complex perianal fistula is defined as a fistula presenting one of these conditions:

    • Trans-sphincteric, supra-sphincteric or extra-sphincteric tract, determined with:
    • Clinical criteria: No palpation of the tract and surgical exploration
    • Radiological criteria: Nucleal Magnetic Resonance (NMR)or Echoendoscopy
    • Multiple fistulas
    • "Horseshoe" fistula
    • Any fistula with fecal incontinence associated
    • Any fistula with a risk of fecal incontinence as a result of:
    • previous anal fistula surgery or other perianal pathology (hemorrhoids, fissures), that involves lesions or muscular complications.
    • Obstetric or iatrogenic sphincter lesions
  2. Patients with Crohn Disease (CD) at screening and been diagnosed within 12 months before acceptance of clinical, endoscopical, anatomopathological and/or radiological criteria and have a non-active CD.(Crohn´s Disease Activity Index (CDAI)≤ 200)
  3. > 18 Years and both genders eligible.
  4. Negative pregnancy test In female fertile subjects
  5. Patient must voluntary sign the informed consent before performance of any study-related procedure not part of normal medical care.
  6. Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements

Exclusion Criteria:

  1. Patients with a highly active CD, i.e., if they meet any of the following criteria:

    • Presence of severe proctitis (prominent friability, spontaneous bleeding, multiple erosions, deep ulcers) or dominant active luminal disease that requires immediate treatment, revealed by rectosigmoidoscopy
    • CDAI ≥201
  2. Presence of abscess or other collections not drained (revealed by basal radiologic study).
  3. Presence of setons drainage, unless they are removed before treatment beginning.
  4. Rectal and/ or anal stenosis revealed with rectoscopy or EBA.
  5. Patients needs surgery in the perianal region for other reasons than fistulas at inclusion or within 26 weeks after treatment administration.
  6. Patients who have received infliximab or any other anti-TNF agent within 8 weeks before the cell treatment administration.
  7. Patients who have received tacrolimus or cyclosporine within 4 weeks before cell treatment.
  8. Patients with a history of alcohol or other addictive substances abuse within 6 months before inclusion.
  9. Severe uncontrolled diseases (chronic renal failure, cardio, pulmonary,…).
  10. Any type of medical or psychiatric disease which are considered as exclusion criteria, in the investigator's opinion.
  11. Patients with diagnosis of malignant neoplasia, except basal cell or epidermoid carcinoma of the skin or previous history of malignant tumours, except those that have no evidence of relapse for at least 5 years.
  12. Subjects with congenital or acquired immunodeficiency.
  13. Positive serology for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV).
  14. Patient had major surgery or serious traumatism within 6 weeks before enrolment.
  15. Pregnant or breast-feeding women.
  16. Physical or psychical impossibility of following the protocol requirements
  17. Patients who are receiving or received other investigational drugs within 30 days prior to basal visit.
  18. Impossibility of doing an radiological exploration (reaction to contrast material, pacemakers, claustrophobia,…)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autologous mesenchymal stem cells
Fistulizing Crohn's disease
Other: Autologous mesenchymal stem cells

The trial is divided in three phases:

I. - Selection: Patients evaluation for study eligibility will take place within two weeks after Informed Consent signature.

II.- Treatment phase includes:

  1. Liposuction procedure to obtain adipose tissue.
  2. Processing and production of Autologous Mesenchymal Stem Cells from adipose tissue (ASCs)
  3. ASCs implant

III.- Follow up: Study visits post-implant will take place at the 1st week (+/- 3 days), 4th week (+/- 3 days), 8th week (+/- 7 days), 12nd week (+/- 7 days), 24th week (+/- 7 days), and 1 year (+/- 7 days) after implant.

Other Names:
  • Implant of ASCs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Security and tolerance
Time Frame: 3 years
Evaluation of viability, security and tolerance of the adipose-derived mesenchymal stem cells implant (ASCs) in fistulizing Chron's disease patients, collecting the reactions and adverse events occurred during the study
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
therapeutic effect
Time Frame: 3 years

  1. Evaluting the ASCs therapeutic effect, in particular:

    • Fistulas healing efficiency
    • Changes in quality of life in patients treated
    • Changes of systemic Crohn's disease after implant
    • Relapse rate monitored among patients who achieved ASCs treatment success.

  2. Achieving the biological characterization of the cell product used and its correlation with the therapeutic effect measured with:

    • Phenotype study
    • Suppressor capacity study.
    • Citoquines production analysis
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Investigators

  • Study Director: Felipe Prosper, MD, PhD, Clinica Universidad de Navarra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

July 5, 2010

First Submitted That Met QC Criteria

July 6, 2010

First Posted (Estimate)

July 7, 2010

Study Record Updates

Last Update Posted (Estimate)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSM/CROH
  • 2009-009880-71 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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