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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 Inclusion:
Key Exclusion:
Detailed eligibility will be reviewed when you contact the study team.