Re-treatment From a Phase I Study of MSC-AFP in Patients With Perianal Fistulas (MSC-AFP)
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|ClinicalTrials.gov Identifier: NCT03209700|
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : January 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Perianal Fistula Cryptoglandular Perianal Fistula Crohn's Perianal Fistula||Drug: MSC-AFP||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: MSC-AFP Single Treatment Group
Eligible patients will be treated, single treatment group, no placebo arm
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
- 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
- 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.
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
|United States, Minnesota|
|Mayo Clinic in Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||William A Faubion, M.D.||Mayo Clinic|
|Principal Investigator:||Eric J Dozois, M.D.||Mayo Clinic|