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

Detailed criteria

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

Biological
E-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 Center
New York, New York

A Multi-center, Randomized, No Treatment, Concurrent Controlled Study of E-CEL UVEC CELLS for the Treatment of Perianal Fistula

Summary

Eligibility

Interventions

Location

Compensation

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Details

Conditions