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New treatment option for Anal Fistula
Official title E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas
ClinicalTrials.gov ID: NCT04190862
What this study is testing
What is E-CEL UVEC?
E-CEL UVEC is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for anal fistula.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine if endothelial cells derived from 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject ages 18 or older
- Subject willing and able to provide informed consent
- Subject is medically eligible and have agreed to undergo a fistulotomy
- Subject with simple perianal fistula with 2 or fewer fistula tracts
- Maximum tract length of 3 inches
You likely can't join if
- Concomitant rectovaginal fistulas
- people with an abscess
- Presence of active infections findings (e.g.; redness, swelling, tenderness or fever)
- Presence of rectal and/or anal stenosis
- The presence of setons unless removed prior to the treatment
- people with ongoing steroid treatment or treated with steroids in the last 4 weeks
See the full eligibility criteria
- Subject ages 18 or older
- Subject willing and able to provide informed consent
- Subject is medically eligible and have agreed to undergo a fistulotomy
- Subject with simple perianal fistula with 2 or fewer fistula tracts
- Maximum tract length of 3 inches
- Subject without history of Crohn's disease/ Ulcerative Colitis
- For female people of childbearing potential:
- A negative serum or urine pregnancy test at screening is required prior to enrollment
- Subject must be willing to use a highly effective method of contraception from the start of the screening period throughout the study period
- For males who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception:
- Subject 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...
- Concomitant rectovaginal fistulas
- people with an abscess
- Presence of active infections findings (e.g.; redness, swelling, tenderness or fever)
- Presence of rectal and/or anal stenosis
- The presence of setons unless removed prior to the treatment
- people with ongoing steroid treatment or treated with steroids in the last 4 weeks
- 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 abuse of alcohol or other addictive substances in the 6 months prior to enrollment
- Active malignant tumor within 5 years
- Current recent history of abnormal, severe, progressive, uncontrolled hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases
- Congenital or acquired immunodeficiencies including human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
- Major surgery or severe trauma within the previous 6 months
- people who are candidates for solid organ transplantation or who may have a high likelihood of needing a solid organ transplant (ex. progressive heart failure)
- Females who are who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment
- people who have known hypersensitivity or documented allergy to DMSO
- people who do not wish to or cannot comply with study procedures
- people currently receiving, or having received any investigational drug within 3 months prior to E-CEL UVEC cell therapy
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.