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.
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- 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.