A Single Patient Treatment Plan with Autologous Mesenchymal Stromal Cell Coated Fistula Plug in a Single Patient with Persistent Pouch-Vaginal Fistula
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 ...