E-CEL UVEC Cell Injection Treatment of Perianal Fistulas

ConditionCryptoglandular Perianal Fistula

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorAngiocrine Bioscience

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 or older

Willing and able to provide informed consent and medically eligible

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

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

E-CEL UVEC Cells
Biological/Vaccine
IP treatment involves percutaneous injections along the entire fistula tract and submucosal injections into the internal tract opening using anoscopic visualization

Treatment groups

78 Participants

are divided into 2 treatment groups

Group A: Arm A, ActiveExperimental treatment 1 intervention

Group B: Arm B, No Treatment Concurrent Control, eligible for crossoverNo intervention 0 interventions

Trial outcomes

Primary outcomes

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

CR is defined as achieving all the following four criteria: 1. Closure of internal opening, plus 2. Closure of external tract, plus 3. No discharge upon digital pressure, plus 4. No clinically meaningful pain

Time frame

Week 12

Secondary outcomes

Changes in the anal fistula quality of life (AF-QoL) scale

To assess changes in the quality of life * Pre-treatment (just prior to 1st treatment) versus 12 weeks after the 1st treatment * Pre-treatment (just prior to 1st treatment) versus 24 weeks after the 1st treatment * Pre-treatment (just prior to 1st treatment) versus 36 weeks after the 1st treatment

Time frame

Weeks 12, 24, and 36 after first treatment

Other outcomes

Cumulative incidence of Clinical Response from visit Day 0 to visit Week 12 over time between Arm A and Arm B [key 2° endpoint]

Time frame

Arm A (Week 12) and Arm B (Week 24)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Angiocrine Bioscience

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: