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Stem Cell Fistula Plug in Perianal Crohn's Disease (MSC-AFP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
William A. Faubion, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01915927
First received: July 31, 2013
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (the Gore® Bio-A®; Fistula Plug) in a Phase I study using a single dose of 20 million cells. Twenty adult patients (age 18 years or older) with refractory, complicated perianal fistulizing Crohn's disease will be enrolled. Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton with continuation of pre-existing anti-Crohn's therapy. Six weeks post placement of the draining seton, the seton will be replaced with the MSC loaded Gore® Bio-A® fistula plug as per current clinical practice. The subjects will be subsequently followed for fistula response and closure for 24 months. This is an autologous product derived from the patient and used only for the same patient.


Condition Intervention Phase
Perianal Crohn's Disease
Drug: MSC-AFP
Phase 1

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 1 Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohn's Disease.

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • To determine the safety and toxicity of using autologous MSC coated fistula plug in patients with fistulizing Crohn's Disease. [ Time Frame: 2-24 months ] [ Designated as safety issue: Yes ]
    The primary endpoint of this study is to determine the safety and feasibility of using adipose derived, autologous mesenchymal stromal cells (MSC) bound to the Gore® Bio-A® Fistula Plug for treatment of refractory CD perianal fistulae.


Secondary Outcome Measures:
  • To assess in preliminary fashion the response of fistula healing induced by the GORE plug containing MSC [ Time Frame: 2-24 months ] [ Designated as safety issue: No ]
    To assess in preliminary fashion the response of fistula healing induced by the GORE plug containing MSC i) Clinically by drainage assessment and ii) Radiographically by MRI, the gold standard test for assessment of healing.


Estimated Enrollment: 20
Study Start Date: July 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Males and females 18-65 years of age.
  • Residents of the United States.
  • Crohn's disease with single or multiple draining complex perianal fistulae (definition as below) for at least three months despite standard therapy (definition below).
  • Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, and anti-TNF therapy are permitted.
  • All patients should have undergone a colonoscopy in last 12 months to rule out malignant or premalignant condition
  • Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia
  • Ability to comply with protocol
  • Competent and able to provide written informed consent
  • Must have failed standard medical therapy including anti-TNF agents

Exclusion Criteria

  • Inability to give informed consent.
  • Clinically significant medical conditions within the six months before administration of MSCs: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
  • Specific exclusions: Evidence of hepatitis B, C, or HIV
  • History of cancer including melanoma (with the exception of localized skin cancers)
  • Investigational drug within thirty (30) days of baseline
  • A resident outside the United States
  • Pregnant or breast feeding.
  • History of clinically significant auto-immunity (other than Crohn's disease) or any previous example of fat-directed autoimmunity
  • Previous allergic reaction to a perianal fistula plug.
  • If liposuction is not technically feasible
  • Allergic to local anesthetics
  • Pregnant patients or trying to become pregnant.
  • Non-enterocutaneous tracts (ie recto-vaginal, entero-vesicular)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01915927

Contacts
Contact: Gwen M Boe, RN 507-266-9917 boe.gwen@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Gwen M Boe, RN    507-266-9917    boe.gwen@mayo.edu   
Principal Investigator: William A Faubion, MD         
Sponsors and Collaborators
William A. Faubion, M.D.
Investigators
Principal Investigator: William Faubion, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: William A. Faubion, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01915927     History of Changes
Other Study ID Numbers: 12-009716
Study First Received: July 31, 2013
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on October 23, 2014