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Re-treatment From a Phase I Study of MSC-AFP in Patients With 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: NCT03209700
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
William A. Faubion, M.D., Mayo Clinic

Brief Summary:
This study is an extension to re-treat partial and non-responders from the previously approved Phase 1 MCS-AFP protocols IRB #12-009716 (Crohn's Disease perianal fistulas) and 15-003200 (cryptoglandular perianal fistulas).

Condition or disease Intervention/treatment Phase
Perianal Fistula Cryptoglandular Perianal Fistula Crohn's Perianal Fistula Drug: MSC-AFP Phase 1

Detailed Description:

This study is an extension to re-treat partial and non-responders from the previously approved Phase 1 MCS-AFP protocols IRB #12-009716 (Crohn's Disease perianal fistulas) and 15-003200 (cryptoglandular perianal fistulas). This study will enroll patients that have persistent symptomatic perianal disease despite being treated with an MSC coated fistula plug, and also treat patients that have had recurrence of their perianal fistula.

As per the previously approval treatment under IND 15356, patients will have a single affected fistula treated, which is the same fistula that was treated in the original protocol. The matrix for delivering the cells is a Gore Bio-A Fistula Plug.

Subjects will be screened at outpatient clinic visits and interested qualified subjects will be offered participation in the trial and consented. At the first study visit (Visit 1; Screening visit), the patient will be evaluated and assessment will be made if an EUA is clinically necessary to assess the fistula. As this is a re-treatment trial, patients with incomplete response to initial plug placement typically have close follow up, recent MRI imaging, and may have a seton in place. If an EUA is clinically indicated, this would be by a colorectal surgeon for drainage of sepsis and placement of a seton as part of the standard clinical care for perianal fistula.

Patients will return on: Day 1, Week 4, Week 12, and Week 24.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Re-treatment for Partial or Non-responders for a Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Perianal Fistulas
Actual Study Start Date : July 20, 2017
Actual Primary Completion Date : December 10, 2019
Actual Study Completion Date : December 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: MSC-AFP Single Treatment Group
Eligible patients will be treated, single treatment group, no placebo arm
Drug: MSC-AFP
Eligible patients will be treated with a fistula plug that has been coated with autologous mesenchymal stromal cells.
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: 6-12 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 perinal 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: 6 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.



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 draining perianal fistula for at least three months despite standard therapy
  4. Concurrent therapies are permitted (such as antibiotics, corticosteroids, thiopurines).
  5. Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia
  6. Ability to comply with protocol
  7. Competent and able to provide written informed consent
  8. Patients that were treated with an MSC-coated fistula plug in the study IRB#12-009716 or IRB#15-003200

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. Previous allergic reaction to a perianal fistula plug.
  8. Allergic to local anesthetics
  9. Pregnant patients or trying to become pregnant or breast feeding.
  10. Non-enterocutaneous tracts (i.e. recto-vaginal, entero-vesicular)

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): NCT03209700


Locations
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United States, Minnesota
Mayo Clinic in Minnesota
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
William A. Faubion, M.D.
Investigators
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Principal Investigator: William A Faubion, M.D. Mayo Clinic
Principal Investigator: Eric J Dozois, M.D. Mayo Clinic
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Responsible Party: William A. Faubion, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT03209700    
Other Study ID Numbers: 17-004503
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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