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New treatment option for Chronic Anal Fissure
Official title E-CEL UVEC Treatment for Anal Fissures
ClinicalTrials.gov ID: NCT06456073
What this study is testing
What is E-CEL UVEC cells (AB-207)?
E-CEL UVEC cells (AB-207) is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for chronic anal fissure.
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
- This clinical trial is being conducted by investigators who are colorectal surgeons. Eligible study participants will receive the experimental treatment E-CEL UVEC cells by direct injection into the anal fissure.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
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. Healthy volunteers may be eligible.
You may be able to join if
- Adults 18 years and older
- Anterior or posterior chronic anal fissure (CAF) - chronicity defined as presence of anal fissure ≥ 6 weeks
- Inadequate response to medical treatment of anal fissure (1 month of failed vasodilator treatment plus declined or failed botulinum injection...
- Recent history of pain on defecation at a level 4 or higher on the numerical rating scale (NRS)
- Vital signs upon screening:
You likely can't join if
- Lateral anal fissure
- Presence of peri-anal or rectovaginal fistula, rectal or anal stenosis, or peri-anal abscess or non-healing peri-anal post-surgical wounds that are...
- Active, untreated or medically unresponsive infection of the anal fissure or fistula (e.g., erythema and pus)
- Active systemic infection (e.g., bacteremia, sepsis) - stable, controlled and treated HIV+ people (e.g., recent plasma HIV RNA \<200 copies/mL) are...
- Presence of inflammatory bowel diseases (e.g., Crohn's, ulcerative colitis)
- Taking systemic chemotherapy or local pelvic radiation treatments
See the full eligibility criteria
- Adults 18 years and older
- Anterior or posterior chronic anal fissure (CAF) - chronicity defined as presence of anal fissure ≥ 6 weeks
- Inadequate response to medical treatment of anal fissure (1 month of failed vasodilator treatment plus declined or failed botulinum injection treatment)
- Recent history of pain on defecation at a level 4 or higher on the numerical rating scale (NRS)
- Vital signs upon screening:
- Blood pressure: systolic ≥ 90 and \< 140; and diastolic ≥ 60 and \< 90.
- Breathing: ≥ 12 and ≤ 20 breaths per minute.
- Pulse: ≥ 60 and ≤ 100 beats per minute.
- Temperature: ≥ 97.8°F and ≤ 99.1°F (36.5°C to 37.3°C)
- O2 saturation: \> 92%
- Willing to take adequate contraceptive measures
- Willing to sign an informed consent form and follow instructions for the trial including appearing for visits and filling out questionnaires
- Lateral anal fissure
- Presence of peri-anal or rectovaginal fistula, rectal or anal stenosis, or peri-anal abscess or non-healing peri-anal post-surgical wounds that are not anal fissures (people with history of anorectal surgery with healed...
- Active, untreated or medically unresponsive infection of the anal fissure or fistula (e.g., erythema and pus)
- Active systemic infection (e.g., bacteremia, sepsis) - stable, controlled and treated HIV+ people (e.g., recent plasma HIV RNA \<200 copies/mL) are not excluded
- Presence of inflammatory bowel diseases (e.g., Crohn's, ulcerative colitis)
- Taking systemic chemotherapy or local pelvic radiation treatments
- Renal impairment defined by serum creatinine ≥ 1.5 x upper limit of normality (ULN)
- Hepatic impairment defined by both of the following laboratory ranges: (a) total bilirubin ≥ 1.5 x ULN unless benign congenital hyperbilirubinemia; and (b) aspartate aminotransferase (AST) and alanine aminotransferase...
- Active alcohol or substance use that, in the opinion of the site investigator, will interfere with study follow-up.
- Active malignant tumor (tumors must be in remission for ≥ 6 months without maintenance chemotherapy and/or radiation)
- Ongoing or recent history (within 6 months) of abnormal, severe, progressive, or uncontrolled hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases
- Congenital immunodeficiencies
- History of major surgery or severe trauma within the previous 3 months
- people who are actively being considered as 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 pregnant or breastfeeding or planning to become pregnant or breastfeed during the study (180 days)
- people who have known hypersensitivity or documented allergy to DMSO
- people who do not wish to or cannot comply with study procedures
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. Healthy volunteers may be eligible. 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.