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E-CEL UVEC Cell Therapy for Anal Fistulas
Phase 1
Recruiting
Led By Jeffrey W Milsom, 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
Subject without history of Crohn's disease/ Ulcerative Colitis
Subject with simple perianal fistula with 2 or fewer fistula tracts
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 24 weeks after surgery
Awards & highlights
Study Summary
This trial is testing whether it's safe to use human umbilical vein cells to help heal anal fistulas.
Who is the study for?
Adults with simple anal fistulas, not exceeding 2 tracts or 3 inches in length, without Crohn's disease/Ulcerative Colitis. Participants must be able to consent and agree to a fistulotomy surgery. They should not have certain health conditions like severe renal or hepatic impairment, active infections, or recent major surgeries. Contraception use is required for those who can conceive.Check my eligibility
What is being tested?
The trial tests if endothelial cells from human umbilical veins (E-CEL UVEC) are safe when used alongside standard surgical treatment (fistulotomy) for healing simple anal fistulas.See study design
What are the potential side effects?
Potential side effects aren't specified but may include typical risks associated with cell therapies such as immune reactions, infection at the injection site, and complications related to the underlying condition being treated.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have never had Crohn's disease or Ulcerative Colitis.
Select...
I have a simple perianal fistula with up to 2 tracts.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6, 24 weeks after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6, 24 weeks after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety of dose escalation, as measured by incidence rate of treatment emergent adverse events following the administration of E-CEL UVEC
Secondary outcome measures
Efficacy of E-CEL UVEC, as measured by time to complete healing of each side
Efficacy of E-CEL UVEC, as measured the rate of subjects presenting with relapse in treated fistula
Long-Term Safety of E-CEL UVEC, as measured by the number of adverse events at 6 weeks following the administration of E-CEL UVEC
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Cell Therapy Treatment Part BExperimental Treatment1 Intervention
Adult subjects with simple perianal fistula who meet all eligibility criteria to participate in Part B of the study will be treated in the outpatient setting with curettage and E-CEL UVEC cells without fistulotomy. E-CEL UVEC cells will be injected along the two sides (180 degrees apart from each other) of the whole length of the curetted anal fistula tract.
Group II: Cell Therapy TreatmentExperimental Treatment1 Intervention
Patients who present with simple anal fistula and elect to undergo fistulotomy for treatment will be eligible to have E-CEL UVEC injected into the fistula at the time of fistulotomy to aid in healing.
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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,283 Total Patients Enrolled
Angiocrine BioscienceIndustry Sponsor
4 Previous Clinical Trials
202 Total Patients Enrolled
Jeffrey W Milsom, MDPrincipal InvestigatorWeill Medical College of Cornell University
2 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have setons or they will be removed before treatment.My kidney function is reduced, with creatinine clearance below 90 mL/min or serum creatinine ≥ 1.5 times the normal upper limit.I have an immune system condition, such as HIV or AIDS.I currently have signs of an infection, like fever or swelling.I have a fistula connecting my rectum and vagina.I have a narrowing in my rectum or anus.I am not pregnant, breastfeeding, nor planning to during treatment.I am currently on steroids or have been treated with steroids in the last month.I agree to use contraception and not donate sperm for 1 year after my treatment.I have never had Crohn's disease or Ulcerative Colitis.My liver function tests show higher than normal levels.I have had an active cancer within the last 5 years.I do not have severe, worsening, uncontrolled health issues in major body systems.I have a simple perianal fistula with up to 2 tracts.I have an abscess.I am 18 years old or older.I am willing and able to follow the study's procedures.I have not had major surgery or severe trauma in the last 6 months.I am medically cleared and have agreed to undergo a fistulotomy.
Research Study Groups:
This trial has the following groups:- Group 1: Cell Therapy Treatment Part B
- Group 2: Cell Therapy Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is this study populated with participants?
"Affirmative, based on the information hosted by clinicaltrials.gov this medical study is currently recruiting. It was originally published on January 22nd 2020 and most recently edited April 29th 2022. They are looking for 12 individuals to enroll in their experiment at one centre."
Answered by AI
What implications does E-CEL UVEC pose for the health of individuals?
"Our team at Power assessed E-CEL UVEC's safety as a 1 due to the limited data on both its efficacy and security, characteristic of Phase 1 trials."
Answered by AI
Is enrollment for this research project still open?
"According to clinicialtrials.gov, this research is actively recruiting for new participants as of 4/29/2022. It was initially posted on 1/22/2020."
Answered by AI
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