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Cell Therapy
E-CEL UVEC Cells for Anal Fissures
Phase 1
Recruiting
Led By Kelly Garrett, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Recent history of pain on defecation at a level 4 or higher on the numerical rating scale (NRS)
Be older than 18 years old
Must not have
Subjects 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)
Active, untreated or medically unresponsive infection of the anal fissure or fistula (e.g., erythema and pus)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 0, 14, 21, 28, 42, 56, 90 and 180
Awards & highlights
No Placebo-Only Group
Summary
"This trial, led by colorectal surgeons, will test a new treatment called E-CEL UVEC cells. Participants will receive injections of these cells directly into the anal fissure to see if it is
Who is the study for?
Adults over 18 with chronic anal fissures not healed by standard treatments, who have stable vital signs and are willing to use contraception. Excluded are those with severe organ issues, active infections or allergies to DMSO, recent major surgery/trauma, substance abuse affecting study compliance, pregnant/breastfeeding women, and certain other health conditions.
What is being tested?
The trial is testing the safety and healing effects of E-CEL UVEC cells injected directly into chronic anal fissures. It's for patients whose fissures haven't improved after at least one month of conventional treatment.
What are the potential side effects?
Potential side effects aren't specified in the provided information but may include typical injection-related reactions such as pain at the injection site, infection risk from the procedure itself, or an immune response to the injected cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience significant pain when using the bathroom.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I might need an organ transplant soon due to my worsening condition.
Select...
I have an active infection in my anal area that hasn't responded to treatment.
Select...
I have a tear on the side of my anal opening.
Select...
I am currently on chemotherapy or receiving radiation in the pelvic area.
Select...
My kidney function is impaired with high creatinine levels.
Select...
I was born with an immune system disorder.
Select...
My liver function tests show bilirubin and enzyme levels higher than normal.
Select...
I have not had major surgery or severe trauma in the last 3 months.
Select...
I am not pregnant, breastfeeding, nor planning to during the study.
Select...
I have an inflammatory bowel disease like Crohn's or ulcerative colitis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 0, 14, 21, 28, 42, 56, 90 and 180
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 0, 14, 21, 28, 42, 56, 90 and 180
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of severe injection site reactions
Proportion of treated responders
Secondary study objectives
Change in proportion of treated responders
Changes in severity of pain on defecation (NRS) from (Day 0) baseline
Mean percent change in fissure-wound from baseline (Day 0)
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intervention ArmExperimental Treatment1 Intervention
Local percutaneous injection of E-CEL UVEC cells around the anal fissure
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,091 Previous Clinical Trials
1,154,734 Total Patients Enrolled
Angiocrine BioscienceIndustry Sponsor
5 Previous Clinical Trials
235 Total Patients Enrolled
Kelly Garrett, MDPrincipal InvestigatorWeill Medical College of Cornell University