Not Yet RecruitingPhase 2

E-CEL UVEC Cell Injection Treatment of Perianal Fistulas

United States78 participantsStarted 2027-05

Plain-language summary

The purpose of this study is to determine if experimental therapy (E-CEL UVEC Cells), a very minimally invasive procedure, can treat patients with perianal fistulas.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age 18 or older
✓. Willing and able to provide informed consent and medically eligible
✓. Diagnosed with perianal fistula per the following criteria:
✓. Diagnosis documented by physical/clinical examination and imaging specifically performed to assess the number and course of the perianal fistula tract---i.e., magnetic resonance imaging (MRI) and/or ultrasound
✓. Single tract without residual abscess cavity
✓. Low transsphincteric and intersphincteric fistulas that cross less than 30% of the external sphincter
✓. For female patients of childbearing potential:
✓. A negative serum or urine pregnancy test at screening is required prior to enrollment

Exclusion criteria

✕. Concomitant rectovaginal fistulas
✕. Patients with an active abscess or suspicion of an active, untreated microabscess
✕. Presence of signs and symptoms suggestive or suspicious of an acute active infection or flare-up.
✕. Fistula-related pain measured as NRS ≥ 3 (NRS Scale 0-10) in the last 7 days.
✕. Presence of rectal and/or anal stenosis
✕. Presence of setons unless removed prior to the treatment
✕. Patients with known bleeding disorders.
✕. Patients with known risk factors for thrombus formation.

What they're measuring

Clinical response (CR) rate at Week 12, comparing Arm A to Arm B in parallel.

Timeframe: Week 12

Trial details

NCT IDNCT07557134

SponsorAngiocrine Bioscience

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-09

Contact for this trial

John R Jaskowiak

877-784-8496 jjaskowiak@angiocrinebio.com

View on ClinicalTrials.gov More Cryptoglandular Perianal Fistula trials