In short
Clinical trials are investigating Adrc in people with crypto-glandular perianal fistula. The studies aim to check whether Adrc-based regenerative cell treatments, used with minimal surgery, can improve healing and assess outcomes in adults with this condition.
Key points
- Clinical trials are investigating Adrc for crypto-glandular perianal fistula, a type of abnormal tunnel near the anus. The study is an interventional Phase 1/2 trial and includes 75 people. It looks at Adrc used with minimal surgical debridement and compares healing over 6 and 12 months. The main outcome is clinical healing, defined by closure of the external opening, no discharge, and no swelling on touch. The trial also includes two forms of Adrc-based treatment: Adrc/SVF and culture expanded Adipose Derived Regenerative Cells, ADRC001.
Trial overview
The available trial is an interventional study, which means researchers actively give a treatment and then measure the results. It is studying Adrc in people with crypto-glandular perianal fistula, a condition that creates an abnormal tunnel near the anus. The study is authorised and planned for 75 participants.
Who is being studied
The trial focuses on patients with crypto-glandular perianal fistula. The source data do not list more detailed age limits, lab tests, or other entry rules. Based on the trial summary, the target group is people who need treatment for a complex perianal fistula that has not healed normally.
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. The intervention list names two Adrc-based products: Adrc/SVF and culture expanded Adipose Derived Regenerative Cells, ADRC001. The study also lists oral antibiotics, metronidazole tablets and Zinnat tablets, as part of the trial treatment plan.
Study design and phase
This trial is in Phase 1/2, which is an early stage of research. Early phase studies usually look at both initial safety and early signs that a treatment may help. 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.
What the trial measures
The main outcome is the healing rate after 6 and 12 months. In this study, clinical healing means the external opening closes, discharge stops, and swelling is no longer felt when the area is touched. These measures help researchers see whether the fistula has improved in a way that matters to patients.
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. The trial is small enough for early research, with 75 planned participants, so it is mainly meant to learn whether the approach is promising. The study name, REP-PAF, describes its focus on repairing peri-anal fistulas with regenerative cell therapeutics.