A Multi-center, Randomized, No Treatment, Concurrent Controlled Study of E-CEL UVEC CELLS for the Treatment of Perianal Fistula
Angiocrine Bioscience
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 18 or older 2. Willing and able to provide informed consent and medically eligible 3. Diagnosed with perianal fistula per the following criteria: 1. 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 2. Single tract without residual abscess cavity 3. Low transsphincteric and intersphincteric fistulas that cross less than 30% of the external sphincter i. Fistula internal opening width ≤ 3 mm. d. M…
Interventions
- BiologicalE-CEL UVEC Cells
IP treatment involves percutaneous injections along the entire fistula tract and submucosal injections into the internal tract opening using anoscopic visualization
Location
- New York Presbyterian/Weill Cornell Medical CenterNew York, New York