A Single Patient Treatment Plan with Autologous Mesenchymal Stromal Cell Coated Fistula Plug in a Single Patient with Persistent Pouch-Vaginal Fistula
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 16-005665
Sponsor Protocol Number: 16-005665
About this study
The purpose of this treatment plan is to use a treatment option only being used within a phase 1 research trial using an autologous mesenchymal stromal cell (MSC) coated fistula plug.
Autologous means these cells to coat the plug come from you.
This treatment plan is still experimental and isn’t approved by the U.S. Food and Drug Administration (FDA). However, the FDA has allowed the use of this drug for a current ongoing research study. We don’t know all the ways that the MSC coated fistula plug may affect people.
The plan is to have 1 patient take part in this treatment plan at Mayo Clinic.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- A Single female patient treatment plan with autologous mesenchymal stromal cell coated fistula plug in patient with persistent pouch-vaginal fistula
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
William Faubion, M.D.
Closed for enrollment
Publications are currently not available