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
|Condition or disease||Intervention/treatment||Phase|
|Perianal Fistula Cryptoglandular Perianal Fistula||Drug: MSC-AFP||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Single Treatment Group
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
- 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
- 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.
- 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.
- 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.
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
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Eric J Dozois, MD||Mayo Clinic|