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Joint Clinical Trials Office

An Open-Label, Single-Center, Investigator Initiated Phase 1B Trial of E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas

Clinical Trial Details

The purpose of this study is to determine if endothelial cells derived from the human umbilical vein are safe for use in conjunction with fistulotomy for the treatment of simple anal fistulas. Endothelial cells are a special kind of cell in the body that line the inside surface of blood vessels. The goal of the study is to evaluate the preliminary safety of human umbilical vein cells in anal fistula healing.

Participants will receive injections of the cells along the outer side of the anal fissure. Photographs of the fissure will be taken by study staff, quality-of-life questionnaires will be administered, and blood samples will be taken at various visits. 

Participants will be asked to return for visits with the study doctor for 6-months following the first E-CEL UVEC cell injection. After the first 6 months, the study team will follow up yearly for up to 15 years via telephone.

 

Key Eligibility: 

Inclusion Criteria:

  1. 18 years of age or older
  2. Has a simple perianal fistula with 2 or fewer fistula tracts and a maximum tract length of 3 inches
  3. Female participants of childbearing potential are required to have a negative serum or urine pregnancy test and must be willing to use a highly effective method of contraception from the start of the screening period throughout the study period
  4. For males who can father a child and are having intercourse with females of childbearing potential must be willing to use a recommended method of contraception and refrain from sperm donation from the start of the conditioning therapy for at least 1 year after completion and discussion with a treating physician.

Exclusion Criteria:

  1. Active malignant tumor within 5 years
  2. Current recent history of abnormal, severe, progressive, uncontrolled hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases
  3. Major surgery or severe trauma within the previous 6 months
  4. Currently receiving, or having received any investigational drug within 3 months prior to E-CEL UVEC cell therapy

Detailed eligibility will be discussed when reaching out to the study team.

Return to List

Study contact by location

Upper East Side - Manhattan

Contact(s)

Rohit Rasane
646-962-2789
rkr4004@med.cornell.edu

Primary Investigator(s)

Jeffery Milsom, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

1904020122

ClinicalTrials.gov:

NCT04190862

Status

Open to Enrollment

Age Group

Adult

Sponsor

  • Angiocrine Bioscience

Disease

Anal Fistula
Surgery