Table of contents
- Trial overview
- Who is being studied
- Treatments being tested
- Study design and phase
- What the trial measures
- How to read the trial results
Trial overview
The available trial is an interventional study, which means researchers actively give a treatment and then measure the results.[1] It is studying Adrc in people with crypto-glandular perianal fistula, a condition that creates an abnormal tunnel near the anus.[1] The study is authorised and planned for 75 participants.[1]
Who is being studied
The trial focuses on patients with crypto-glandular perianal fistula.[1] The source data do not list more detailed age limits, lab tests, or other entry rules.[1] Based on the trial summary, the target group is people who need treatment for a complex perianal fistula that has not healed normally.[1]
Treatments being tested
Adrc is being studied as part of a treatment plan that also includes minimal surgical debridement, meaning only the damaged tissue needed for treatment is removed.[1] The intervention list names two Adrc-based products: Adrc/SVF and culture expanded Adipose Derived Regenerative Cells, ADRC001.[1] The study also lists oral antibiotics, metronidazole tablets and Zinnat tablets, as part of the trial treatment plan.[1]
Study design and phase
This trial is in Phase 1/2, which is an early stage of research.[1] Early phase studies usually look at both initial safety and early signs that a treatment may help.[1] Because this is a Phase 1/2 study, the main goal is not only to see whether the approach may work, but also to learn more about how patients respond in the study setting.[1]
What the trial measures
The main outcome is the healing rate after 6 and 12 months.[1] In this study, clinical healing means the external opening closes, discharge stops, and swelling is no longer felt when the area is touched.[1] These measures help researchers see whether the fistula has improved in a way that matters to patients.[1]
How to read the trial results
When reading this trial, the most important details are the condition being treated, the early phase of the study, and the healing outcome at 6 and 12 months.[1] The trial is small enough for early research, with 75 planned participants, so it is mainly meant to learn whether the approach is promising.[1] The study name, REP-PAF, describes its focus on repairing peri-anal fistulas with regenerative cell therapeutics.[1]
