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Stem Cell Fistula Plug in Cryptoglandular Perianal Fistulas (MSC-AFP)

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: NCT02589119
Recruitment Status : Completed
First Posted : October 28, 2015
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Eric J. Dozois, M.D., Mayo Clinic

Brief Summary:
The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (the Gore Fistula Plug) in a Phase I study using a single dose of 20 million cells. 15 adult patients, ages 18 years and older with cryptoglandular fistulas will be enrolled. Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton. Six weeks post placement of the draining seton, the seton will be replaced with the MSC loaded Gore Fistula Plug; 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 or disease Intervention/treatment Phase
Perianal Fistula Cryptoglandular Perianal Fistula Drug: MSC-AFP Phase 1

Detailed Description:
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. 15 adult patients (age > 18 years) with cryptoglandular fistulas will be enrolled. Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton. Six weeks post placement of the draining seton, the seton will be replaced with the MSC loaded Gore® fistula plug as per current clinical practice. The subjects will be subsequently followed for fistula response and closure for 24 months. Study visits are Day 1, Week 2, Week 4, Week 8, Week 12, Week 24, Week 52, and Week 104. This is an autologous product derived from the patient and used only for the same patient.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With High, Transsphincteric Cryptoglandular Perianal Fistulas
Study Start Date : January 2016
Actual Primary Completion Date : September 2019
Actual Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
MSC-AFP
Single Treatment Group
Drug: MSC-AFP
Eligible patients will be treated with a fistula plug that has been coated with autologous mesenchymal stromal cell.
Other Name: mesenchymal stromal cell coated fistula plug




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events (safety and toxicity). [ Time Frame: 2-24 months ]
    Participants will have a health assessment and blood work measured at each study visit to monitor for adverse events, such as worsening of the cryptoglandular fistulizing disease, abnormal laboratory values, or significant abnormalities in physical examination. The Outcome Measure will be the number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment


Secondary Outcome Measures :
  1. Number of participants with response to the treatment regarding potential cessation of drainage from their fistula. [ Time Frame: 2-24 months ]
    Participants will have a clinical assessment of fistula drainage. Participants will be assessed during an office examination if their fistula is draining or not. The Outcome Measure will be the presence or absence of fistula drainage.


Other Outcome Measures:
  1. Number of participants with response to the treatment regarding their score based on the Cleveland Clinic Florida (Wexner) fecal incontinence questionnaire. [ Time Frame: 6-12 months ]
    Participants will have an assessment with the Cleveland Clinic Florida (Wexner) fecal incontinence questionnaire. Participants have the questionnaire administered within one week before plug implantation and at the 6 month and 12 months follow up visits. The Outcome Measure will be the how the participants' score change over time.

  2. Number of participants with radiographic healing response to the treatment. [ Time Frame: 2-24 months ]
    Participants will have an assessment of healing radiographically by magnetic resonance imaging (MRI). Participants' fistula tracts will be assessed during a MRI if their fistula is healing. The Outcome Measure will be the closure or persistence of fistula tract.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Males and females 18-65 years of age.
  2. Residents of the United States.
  3. Single-tract, transsphincteric anal fistula of cryptoglandular origin. Primary fistulas (no previous surgical treatment) and those who have failed previous surgical repairs
  4. Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia
  5. Ability to comply with protocol
  6. Competent and able to provide written informed consent

Exclusion Criteria

  1. Inability to give informed consent.
  2. 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.
  3. Specific exclusions; Evidence of hepatitis B, C, or HIV
  4. History of cancer including melanoma (with the exception of localized skin cancers)
  5. Investigational drug within thirty (30) days of baseline
  6. A resident outside the United States
  7. Pregnant or breast feeding.
  8. History of clinically significant auto-immunity (e.g. Crohn's disease) or any previous example of fat-directed autoimmunity
  9. Previous allergic reaction to a perianal fistula plug.
  10. If liposuction is not technically feasible
  11. Allergic to local anesthetics
  12. Pregnant patients or trying to become pregnant.
  13. Non-enterocutaneous tracts (i.e. recto-vaginal, entero-vesicular)
  14. Multi-tract, suprasphincteric and extrasphincteric fistula tract extensions
  15. Active local infection associated with the fistula

Information from the National Library of Medicine

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): NCT02589119


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Eric J Dozois, MD Mayo Clinic
Additional Information:
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Responsible Party: Eric J. Dozois, M.D., MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02589119    
Other Study ID Numbers: 15-003200
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019
Keywords provided by Eric J. Dozois, M.D., Mayo Clinic:
cryptoglandular
perianal fistula
cryptoglandular perianal fistulas
Additional relevant MeSH terms:
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Rectal Fistula
Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases