An Open-Label, Single-Center, Investigator Initiated Phase 1B Trial of E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas
Who is this study for? Patients with Anal Fistula
What treatments are being studied? E-CEL UVEC
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The purpose of this study is to determine if endothelial cells derived from human umbilical vein are safe for use in conjunction with fistulotomy for the treatment of simple anal fistulas. Endothelial cells are a special kind of cell in the body that line the inside surface of blood vessels. The goal of the study is to evaluate the preliminary safety of human umbilical vein cells in anal fistula healing.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Subject ages 18 or older
• Subject willing and able to provide informed consent
• Subject is medically eligible and have agreed to undergo a fistulotomy
• Subject with simple perianal fistula with 2 or fewer fistula tracts
• Maximum tract length of 3 inches
• Subject without history of Crohn's disease/ Ulcerative Colitis
• For female subjects of childbearing potential:
• A negative serum or urine pregnancy test at screening is required prior to enrollment
• Subject must be willing to use a highly effective method of contraception from the start of the screening period throughout the study period
• For males who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception:
• Subject must be willing to use a recommended method of contraception and refrain from sperm donation from the start of the conditioning therapy for at least 1 year after completion and discussion with a treating physician
Locations
United States
New York
Weill Cornell Medical College - NewYork-Presbyterian Hospital
RECRUITING
New York
Contact Information
Primary
KM Muktasid
kmm4010@med.cornell.edu
646-962-2789
Backup
Ananya Sen
ase4003@med.cornell.edu
646-962-6445
Time Frame
Start Date:2020-01-22
Estimated Completion Date:2032-06-30
Participants
Target number of participants:39
Treatments
Experimental: Cell Therapy Treatment
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.
Experimental: Cell Therapy Treatment Part BS1
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.
Experimental: Cell Therapy Treatment Part BS2
Subjects in Part B2-S will have the same eligibility criteria and would undergo the same procedure as described in Part B1, except that B2-S subjects will also have suturing and injection of the internal opening.
Experimental: Cell Therapy Treatment Part BM1
Subjects in Part BM1 will have the same eligibility criteria and would undergo the same procedure as described in Part B1, except that B2-M subjects in this cohort are eligible for up to 4 treatments (versus 1 in Part BS2).
Experimental: Cell Therapy Treatment Part BM2
This cohort comprises of multiple (M) treatments with E-CEL UVEC injections. The difference between Part BM1 and Part BM2, is that the subjects in the latter cohort receive double the dose of E-CEL UVEC cells per treatment. Subjects in Part BM2 will have the same eligibility criteria as Part BS1, BS2 and BM1 cohorts and would undergo the same treatment procedure as described in Parts BS1, BS2 and BM1.~Every treatment consists of the percutaneous injection along both sides of the fistula tract plus injection of the internal opening via direct anoscopic visualization (described in the next paragraph). Dosing is 30 x 106 viable E-CEL UVEC cells into the area of the internal opening and minimum 30 x 106 viable E-CEL UVEC cells per centimeter along the fistula tract (15x106 viable E-CEL UVEC cells, each side per centimeter of the tract).~All subjects in this cohort receive up to 6 treatments over 6 months. The six treatments are administered on visits WK 0, 3. 6, 9, 12 and 24.