Repairing Peri-Anal Fistulas with regenerative cell therapeutics: study protocol for a double-blinded randomized controlled phase I-II trial from Denmark (REP-PAF) - PubMed
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- #Clinical trial
- #Stem cell therapy
- #Peri-anal fistula
- Study evaluates regenerative cell therapeutics for repairing peri-anal fistulas (PAFs) in a double-blinded, randomized controlled phase I-II trial.
- Primary outcome is clinical healing rate after 12 months; secondary outcomes include quality of life, anal continence, and comparison of autologous vs. allogeneic adipose-derived regenerative cells (ADRCs).
- Inclusion criteria: adults (≥18 years) with complex PAFs involving >30% of the anal sphincter. Exclusion criteria include inflammatory bowel disease, pregnancy, and certain infections.
- Treatment involves minimal surgical debridement, liposuction, and injection of autologous microfat plus ADRCs (autologous or allogeneic ADRC001).
- Follow-up visits at 3, 6, and 12 months post-surgery; serious adverse events monitored.
- Trial aims to provide evidence on efficacy of allogeneic ADRCs as an alternative to autologous ADRCs, with potential benefits including minimal invasiveness and preserved sphincter function.
- 75 patients to be recruited over 3 years, starting October 2024, at Odense University Hospital, Denmark.
- Approved by EMA and monitored by GCP Unit; registered in Clinical Trials Information System (CTIS) and ClinicalTrials.gov.