E-CEL UVEC Cell Injection Treatment of Perianal Fistulas

NCT07557134 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: AB-ECELUVEC-201
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cryptoglandular Perianal Fistula

Outcome Measures

Primary Outcomes (1)

• 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

  Week 12

Secondary Outcomes (1)

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

  Weeks 12, 24, and 36 after first treatment

Other Outcomes (1)

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

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

Study Arms (2)

Arm A, Active

EXPERIMENTAL

Biological: E-CEL UVEC Cells

Arm B, No Treatment Concurrent Control, eligible for crossover

NO INTERVENTION

Interventions

E-CEL UVEC Cells BIOLOGICAL

IP treatment involves percutaneous injections along the entire fistula tract and submucosal injections into the internal tract opening using anoscopic visualization

Also known as: Allogeneic genetically engineered human umbilical vein endothelial cells

Arm A, Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• i. Fistula internal opening width ≤ 3 mm. d. Maximum tract length of 10 cm e. Consistent with cryptoglandular origin f. Fistula-related pain of NRS \< 3 (NRS 0-10) g. Absence of history of Crohn's disease, ulcerative colitis or other inflammatory bowel diseases
• For female patients of childbearing potential:
• A negative serum or urine pregnancy test at screening is required prior to enrollment
• Patient must be willing to use a highly effective method of contraception from the start of the screening period until at least 3 months after completion of last treatment
• For male patients who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception:
• Patient must be willing to use a recommended method of contraception and refrain from sperm donation from the start of screening period until for at least 3 months after completion of the last treatment

You may not qualify if:

• 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.
• Patients with overlying wound and skin infections.
• Patients with ongoing systemic steroid treatment or treated with steroids within the last 4 weeks prior to treatment
• Renal impairment defined by creatinine clearance below 90 mL/min calculated using Cockcroft-Gault formula or by serum creatinine ≥ 1.5 x upper limit of normality (ULN)
• Hepatic impairment defined by both of the following laboratory ranges:
• Total bilirubin ≥ 1.5 x ULN unless benign congenital hyperbilirubinemia.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 2.5 x ULN
• Known history of untreated alcohol or other addictive substance abuse in the 6 months prior to enrollment

Sponsors & Collaborators

• Angiocrine Bioscience: lead

Study Sites (1)

New York Presbyterian/Weill Cornell Medical Center

New York, New York, 10028, United States

Location

Central Study Contacts

John R Jaskowiak

CONTACT

877-784-8496; jjaskowiak@angiocrinebio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is designed as an adequate and well-controlled study per 21 CFR 314.126. Specifically, this study utilizes one of the recognized controls: no treatment concurrent control. Primary endpoint consists of objective measurements of effectiveness. Placebo effect for this indication and target population is regarded as negligible. Moreover, a placebo concurrent control is regarded as infeasible for the treatment regimen to treat perianal fistula.

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 29, 2026
• Study Start (Estimated): May 1, 2027
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)