E-CEL UVEC Cell Injection Treatment of Perianal Fistulas

Part of paid clinical trials in New York, New York.

Sponsor
Angiocrine Bioscience
Study ID
NCT07557134
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Cryptoglandular Perianal Fistula

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
May 31, 2027
Status verified
Apr 2026
Primary completion
Sep 30, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A, Active
  • No Intervention: Arm B, No Treatment Concurrent Control, eligible for crossover

Primary Outcome Measure

Clinical response (CR) rate at Week 12, comparing Arm A to Arm B in parallel. [ Time Frame: Week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New York Presbyterian/Weill Cornell Medical CenterNew YorkNew York10028
Jeffrey W Milsom, MD, FACS (PRINCIPAL_INVESTIGATOR)

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