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An Open-Label, Single-Center, Investigator Initiated Phase 1B Trial of E-CEL UVEC Cell Therapy for the Treatment of Chronic Anal Fissure

Clinical Trial Details

 This study is evaluating the initial safety and efficacy of local injections of E-CEL UVEC cells, which are genetically engineered (pro-survival gene, E4ORF1+), human umbilical vein endothelial cells, as an experimental treatment of patients with chronic anal fissure (CAF) who have failed medical therapy (i.e., topical vasodilators ± botulinum injection). 

Experimental means that E-CEL UVEC is not approved by the U.S Food and Drug Adminstration. 

This research study is being done because, in animal studies, E-CEL UVEC cells have been shown to aid in restoring or accelerating the normal healing in various tissues. This study will test if it is safe to use E-CEL UVEC cell therapy and if they it would aid in restoring or improve healing of CAF that was not responding to medical therapy. 

The study is a non-randomized, open-label, single arm study, meaning every study participant will receive some dose of the experimental study drug. There is no placebo.

Participants will receive percutaneous (under the skin) injections of E-CEL UVEC cell product along the sides of the fissure. The treatments are spaced 3 to 4 weeks apart. Initial safety and efficacy parameters will be observed over a 6-month period, followed by a long-term follow-up consisting of an annual questionnaire provided by electronic means.
   

Key Eligibility: 

Key Inclusion: 

  1. Adults 18 years and older
  2. Anterior or posterior chronic anal fissure (CAF) - chronicity defined as presence of anal fissure ≥ 6 weeks
  3. Inadequate response to medical treatment of anal fissure (1 month of failed vasodilator treatment plus declined or failed botulinum injection treatment)

Key Exclusion: 

  1. Presence of inflammatory bowel diseases (e.g., Crohn's, ulcerative colitis)
  2. 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
  3. Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed during the study

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

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

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2311026760

ClinicalTrials.gov:

NCT06456073

Status

Open to Enrollment

Age Group

Adult

Sponsor