RECRUITING

E-CEL UVEC Treatment for Anal Fissures

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-09

Study Completion:2025-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06456073

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Adults 18 years and older 2. Anterior or posterior chronic anal fissure (CAF) - chronicity defined as presence of anal fissure ≥ 6 weeks 3. Inadequate response to medical treatment of anal fissure (1 month of failed vasodilator treatment plus declined or failed botulinum injection treatment) 4. Recent history of pain on defecation at a level 4 or higher on the numerical rating scale (NRS) 5. Vital signs upon screening: * Blood pressure: systolic ≥ 90 and \< 140; and diastolic ≥ 60 and \< 90. * Breathing: ≥ 12 and ≤ 20 breaths per minute. * Pulse: ≥ 60 and ≤ 100 beats per minute. * Temperature: ≥ 97.8°F and ≤ 99.1°F (36.5°C to 37.3°C) * O2 saturation: \> 92% 6. Willing to take adequate contraceptive measures 7. Willing to sign an informed consent form and follow instructions for the trial including appearing for visits and filling out questionnaires	1. Lateral anal fissure 2. Presence of peri-anal or rectovaginal fistula, rectal or anal stenosis, or peri-anal abscess or non-healing peri-anal post-surgical wounds that are not anal fissures (subjects with history of anorectal surgery with healed surgical wound is not excluded) 3. Active, untreated or medically unresponsive infection of the anal fissure or fistula (e.g., erythema and pus) 4. Active systemic infection (e.g., bacteremia, sepsis) - stable, controlled and treated HIV+ subjects (e.g., recent plasma HIV RNA \<200 copies/mL) are not excluded 5. Presence of inflammatory bowel diseases (e.g., Crohn's, ulcerative colitis) 6. Taking systemic chemotherapy or local pelvic radiation treatments 7. Renal impairment defined by serum creatinine ≥ 1.5 x upper limit of normality (ULN) 8. Hepatic impairment defined by both of the following laboratory ranges: 9. Active alcohol or substance use that, in the opinion of the site investigator, will interfere with study follow-up. 10. Active malignant tumor (tumors must be in remission for ≥ 6 months without maintenance chemotherapy and/or radiation) 11. Ongoing or recent history (within 6 months) of abnormal, severe, progressive, or uncontrolled hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases 12. Congenital immunodeficiencies 13. History of major surgery or severe trauma within the previous 3 months 14. 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) 15. Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed during the study (180 days) 16. Subjects who have known hypersensitivity or documented allergy to DMSO 17. Subjects who do not wish to or cannot comply with study procedures

Inclusion Criteria

Exclusion Criteria

1. Adults 18 years and older
2. Anterior or posterior chronic anal fissure (CAF) - chronicity defined as presence of anal fissure ≥ 6 weeks
3. Inadequate response to medical treatment of anal fissure (1 month of failed vasodilator treatment plus declined or failed botulinum injection treatment)
4. Recent history of pain on defecation at a level 4 or higher on the numerical rating scale (NRS)
5. Vital signs upon screening:
* Blood pressure: systolic ≥ 90 and \< 140; and diastolic ≥ 60 and \< 90.
* Breathing: ≥ 12 and ≤ 20 breaths per minute.
* Pulse: ≥ 60 and ≤ 100 beats per minute.
* Temperature: ≥ 97.8°F and ≤ 99.1°F (36.5°C to 37.3°C)
* O2 saturation: \> 92%
6. Willing to take adequate contraceptive measures
7. Willing to sign an informed consent form and follow instructions for the trial including appearing for visits and filling out questionnaires

1. Lateral anal fissure
2. Presence of peri-anal or rectovaginal fistula, rectal or anal stenosis, or peri-anal abscess or non-healing peri-anal post-surgical wounds that are not anal fissures (subjects with history of anorectal surgery with healed surgical wound is not excluded)
3. Active, untreated or medically unresponsive infection of the anal fissure or fistula (e.g., erythema and pus)
4. Active systemic infection (e.g., bacteremia, sepsis) - stable, controlled and treated HIV+ subjects (e.g., recent plasma HIV RNA \<200 copies/mL) are not excluded
5. Presence of inflammatory bowel diseases (e.g., Crohn's, ulcerative colitis)
6. Taking systemic chemotherapy or local pelvic radiation treatments
7. Renal impairment defined by serum creatinine ≥ 1.5 x upper limit of normality (ULN)
8. Hepatic impairment defined by both of the following laboratory ranges:
9. Active alcohol or substance use that, in the opinion of the site investigator, will interfere with study follow-up.
10. Active malignant tumor (tumors must be in remission for ≥ 6 months without maintenance chemotherapy and/or radiation)
11. Ongoing or recent history (within 6 months) of abnormal, severe, progressive, or uncontrolled hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases
12. Congenital immunodeficiencies
13. History of major surgery or severe trauma within the previous 3 months
14. 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)
15. Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed during the study (180 days)
16. Subjects who have known hypersensitivity or documented allergy to DMSO
17. Subjects who do not wish to or cannot comply with study procedures

Contacts and Locations

Study Contact

Kelly Garrett, MD

CONTACT

646-962-2270

keg9034@med.cornell.edu

Rohit Rasane

CONTACT

rkr4004@med.cornell.edu

Principal Investigator

Kelly Garrett, MD

PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

Kelly Garrett, MD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09

Study Completion Date2025-06-30

Study Record Updates

Study Start Date2024-09

Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

Chronic Anal Fissure

Additional Relevant MeSH Terms

Chronic Anal Fissure