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

Phase 1

Completed

• Conditions: Cryptoglandular Perianal Fistula; Perianal Fistula
• Interventions: Drug: MSC-AFP

• Registration Number: NCT02589119
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2015-10-21
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-28
• Study Start: 2016-01
• Primary Completion: 2019-09
• Study Completion: 2019-09
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-03
• Last Update Posted: 2019-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MSC-AFP	MSC-AFP	Single Treatment Group

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events (safety and toxicity).	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

Name	Time	Method
Number of participants with response to the treatment regarding potential cessation of drainage from their fistula.	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States