Tissue Therapy of Transsphincteric Anal Fistula

ConditionAnal Fistula
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Southern Denmark

About this trial

This clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.

Eligibility criteria

Qualifiers

able to communicate with Danish language

able to provide informed consent

having address in the region of southern Denmark during the study

Disqualifiers

Signs of suppuration/cavitation around the fistula

Simple or low anal fistula, which can be treated by simple surgical incision

Ano-vaginal and recto-vaginal fistula

The presence of more than one fistula tract, more than two external orifices or more than one internal orifice

Trial design

Treatments tested in this trial

  • ADRC injection
  • ADRC001 injection

Treatment groups

75 Participants
are divided into 2 treatment groups

Sponsors and collaborators