Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456073
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-06
Brief Title:
E-CEL UVEC Treatment for Anal Fissures
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
An Open-Label Single-Center Investigator Initiated Phase 1B Trial of E-CEL UVEC Cell Therapy for the Treatment of Chronic Anal Fissure
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial is being conducted by investigators who are colorectal surgeons Eligible study participants will receive the experimental treatment E-CEL UVEC cells by direct injection into the anal fissure The study is being conducted to determine if E-CEL UVEC cell injections will be safe and would have any effects on healing of the anal fissure
Detailed Description:
This Phase 1b trial is conducted to evaluate the initial safety and efficacy of local percutaneous injections of E-CEL UVEC cells 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 ie topical vasodilators botulinum injection The study is a non-randomized open-label single arm study meaning every study participant will receive some dose of the experimental study drug no placebo Consented eligible participants will receive percutaneous 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 annual questionnaire provided by electronic means
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 This study is being led by Dr Kelly Garrett Associate Professor of Surgery and conducted by surgeons in the Colon and Rectal Surgery Division of Weill Cornell Medical College
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 This study is being led by Dr Kelly Garrett Associate Professor of Surgery and conducted by surgeons in the Colon and Rectal Surgery Division of Weill Cornell Medical College
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None