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Re-treatment From a Phase I Study of MSC-AFP in Patients With Perianal Fistulas

NCT03209700 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2020-01-03

No results posted yet for this study

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).

Conditions

  • Perianal Fistula
  • Cryptoglandular Perianal Fistula
  • Crohn's Perianal Fistula

Interventions

DRUG

MSC-AFP

Eligible patients will be treated with a fistula plug that has been coated with autologous mesenchymal stromal cells.

Sponsors & Collaborators

  • William A. Faubion, M.D.

    lead OTHER

Principal Investigators

  • William A Faubion, M.D. · Mayo Clinic

  • Eric J Dozois, M.D. · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-20
Primary Completion
2019-12-10
Completion
2019-12-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03209700 on ClinicalTrials.gov