Chronic Anal FissurePhase 1NCT06456073
E-CEL UVEC Treatment for Anal Fissures
A Phase 1 study testing E-CEL UVEC cells (AB-207) in people with Chronic Anal Fissure, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Anal Fissure
- What is being tested?
- E-CEL UVEC cells (AB-207)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2024to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18 years and older
- Anterior or posterior chronic anal fissure (CAF) - chronicity defined as presence of anal fissure ≥ 6 weeks
- Inadequate response to medical treatment of anal fissure (1 month of failed vasodilator treatment plus declined or failed botulinum injection treatment)
- Recent history of pain on defecation at a level 4 or higher on the numerical rating scale (NRS)
- Vital signs upon screening:
- Blood pressure: systolic ≥ 90 and < 140; and diastolic ≥ 60 and < 90.
Show all 12Show fewer
- 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%
- Willing to take adequate contraceptive measures
- Willing to sign an informed consent form and follow instructions for the trial including appearing for visits and filling out questionnaires
Who cannot join
- Lateral anal fissure
- 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)
- Active, untreated or medically unresponsive infection of the anal fissure or fistula (e.g., erythema and pus)
- 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
- Presence of inflammatory bowel diseases (e.g., Crohn's, ulcerative colitis)
- Taking systemic chemotherapy or local pelvic radiation treatments
Show all 18Show fewer
- Renal impairment defined by serum creatinine ≥ 1.5 x upper limit of normality (ULN)
- Hepatic impairment defined by both of the following laboratory ranges:
- total bilirubin ≥ 1.5 x ULN unless benign congenital hyperbilirubinemia; and (b) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 2.5 x ULN
- Active alcohol or substance use that, in the opinion of the site investigator, will interfere with study follow-up.
- Active malignant tumor (tumors must be in remission for ≥ 6 months without maintenance chemotherapy and/or radiation)
- Ongoing or recent history (within 6 months) of abnormal, severe, progressive, or uncontrolled hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases
- Congenital immunodeficiencies
- History of major surgery or severe trauma within the previous 3 months
- 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)
- Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed during the study (180 days)
- Subjects who have known hypersensitivity or documented allergy to DMSO
- Subjects who do not wish to or cannot comply with study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
KM Muktasid, kmm4010@med.cornell.edu
About this study
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
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.
Read the 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 (i.e., 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. Improvement of CAF would be assessed in a standard, clinical manner (using brief digital palpation by the doctor), a method acceptable to the FDA, versus the original method (detailed quantitative photo-documentation). 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.
- Conditions
- Chronic Anal Fissure
- Being tested
- E-CEL UVEC cells (AB-207)
- Keywords
- Chronic Anal Fissure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-CEL UVEC cells (AB-207)Biological
Allogeneic (consented-maternal donor) E4ORF1+ (pro-survival gene transduced) human umbilical vein endothelial cells (percutaneous injection formulation)
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Local percutaneous injection of E-CEL UVEC cells around the anal fissure Receives: Biological: E-CEL UVEC cells (AB-207) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of severe injection site reactions
Severe refers to Grade ≥ 3 as per CTCAE v5.0 terms and grading
Measured: Up to 180 days
Number of severe injection site reactions that are serious adverse events related to IP
Measured: Up to 180 days
Proportion of treated responders
Treated responders defined as absence of the anal fissure with digital (e.g., index finger) palpation by investigator (supplemented by photo-documentation whenever possible) from baseline
Measured: Up to 180 days
Secondary outcomes (22)
Changes in severity of pain on defecation (NRS) from (Day 0) baseline
Based on Numerical Rating Scale (NRS) measures at timepoints compared to baseline. Scale ranges from 0-10 with 0 representing no pain and severity of pain increasing chronologically.
Measured: Days 0, 14, 21, 28, 42, 56, 90 and 180
Proportion of treated responders
Treated responders defined as absence of the anal fissure with digital (e.g., index finger) palpation by investigator (supplemented by photo-documentation whenever possible) from baseline (Day 0)
Measured: Days 14, 21, 28, 42, 56, 90 and 180
Change in proportion of subjects
Subjects with ≥ 50% reduction in pain-on-defecation (NRS) from baseline (Day 0)
Measured: Days 0, 14, 21, 28, 42, 56, 90 and 180
Proportion of treated subjects who have complete cessation of fissure-related symptoms
Measured: Up to 180 days
Median percent change in fissure-wound from baseline (Day 0)
Median percent change in fissure wound size based on mm^2 using digital photo-image analysis
Measured: Days 0, 14, 21, 28, 42, 56, 90 and 180
Mean percent change in fissure-wound from baseline (Day 0)
Mean percent change in fissure wound size based on mm^2 using digital photo-image analysis
Measured: Days 0, 14, 21, 28, 42, 56, 90 and 180
Proportion of treated subjects who have ≥ 50% wound closure from baseline (Day 0)
Measured: Day 14
Proportion of treated subjects who have ≥ 50% wound closure from baseline (Day 0)
Measured: Day 21
Proportion of treated subjects who have ≥ 50% wound closure from baseline (Day 0)
Measured: Day 28
Proportion of treated subjects who have ≥ 50% wound closure from baseline (Day 0)
Measured: Day 42
Proportion of treated subjects who have ≥ 50% wound closure from baseline (Day 0)
Measured: Day 56
Proportion of treated subjects who have ≥ 50% wound closure from baseline (Day 0)
Measured: Day 90
Proportion of treated subjects who have ≥ 50% wound closure from baseline (Day 0)
Measured: Day 180
Time-to-response in days in treated responders
Treated responders are defined as those with ≥50% reduction in pain on defecation (using numerical rating scale (NRS)) and ≥50% reduction in fissure-wound area from baseline (Day 0).
Measured: Up to 180 days
Time-to symptom improvement in days in treated subjects who achieved symptom improvement
Symptom improvement is defined as a minimum 50% reduction in pain-on defecation (using numerical rating scale (NRS)) in treated subjects.
Measured: Up to 180 days
Time-to 50% wound closure in days in subjects who achieved at least 50% wound closure
Measured: Up to 180 days
Time-to complete wound closure in days in subjects who achieved complete wound closure
Measured: Up to 80
Cumulative number of severe adverse events, defined and graded by NCI CTCAE v5.0
Measured: Up to 180 days
Percent of serious adverse events, including relatedness category
Percent of SAE and relatedness categories of SAE as defined and graded by NCI CTCAE v5.0
Measured: Up to 180 days
Percent of treatment-emergent adverse events per system organ class (SOC)
Measured: Up to 180 days
Proportion of fissure relapse in treated subjects
Fissure relapse is defined as worsening of pain and increase in size after healing.
Measured: Up to 180 days
Time-to-relapse in days in subjects who experienced relapse
Days to relapse from time of healing.
Measured: Up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start12 Sep 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Anal FissureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Angiocrine Bioscience
- Responsible party
- Sponsor
- Investigators
- Kelly Garrett, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456073
- Sponsor's protocol ID
- 23-11026760
- Status last verified
- Apr 2026
- First submitted
- 6 Jun 2024
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06456073
- Acronym / sponsor ID
- 23-11026760
- Conditions
- Chronic Anal Fissure
- Keywords
- Chronic Anal Fissure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Angiocrine Bioscience
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (i.e., 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. Improvement of CAF would be assessed in a standard, clinical manner (using brief digital palpation by the doctor), a method acceptable to the FDA, versus the original method (detailed quantitative photo-documentation). 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Biological: E-CEL UVEC cells (AB-207)Local percutaneous injection of E-CEL UVEC cells around the anal fissure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adults 18 years and older
- Anterior or posterior chronic anal fissure (CAF) - chronicity defined as presence of anal fissure ≥ 6 weeks
- Inadequate response to medical treatment of anal fissure (1 month of failed vasodilator treatment plus declined or failed botulinum injection treatment)
- Recent history of pain on defecation at a level 4 or higher on the numerical rating scale (NRS)
- Vital signs upon screening:
Key exclusion criteria (18 listed)
- Lateral anal fissure
- 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)
- Active, untreated or medically unresponsive infection of the anal fissure or fistula (e.g., erythema and pus)
- 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
- Presence of inflammatory bowel diseases (e.g., Crohn's, ulcerative colitis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-CEL UVEC cells (AB-207)Allogeneic (consented-maternal donor) E4ORF1+ (pro-survival gene transduced) human umbilical vein endothelial cells (percutaneous injection formulation) | Biological | Intervention Arm |
Primary outcome
Number of severe injection site reactions
Time frame: Up to 180 days
Severe refers to Grade ≥ 3 as per CTCAE v5.0 terms and grading
Number of severe injection site reactions that are serious adverse events related to IP
Time frame: Up to 180 days
Proportion of treated responders
Time frame: Up to 180 days
Treated responders defined as absence of the anal fissure with digital (e.g., index finger) palpation by investigator (supplemented by photo-documentation whenever possible) from baseline
22 secondary outcomes
Changes in severity of pain on defecation (NRS) from (Day 0) baseline
Time frame: Days 0, 14, 21, 28, 42, 56, 90 and 180
Proportion of treated responders
Time frame: Days 14, 21, 28, 42, 56, 90 and 180
Change in proportion of subjects
Time frame: Days 0, 14, 21, 28, 42, 56, 90 and 180
Proportion of treated subjects who have complete cessation of fissure-related symptoms
Time frame: Up to 180 days
Median percent change in fissure-wound from baseline (Day 0)
Time frame: Days 0, 14, 21, 28, 42, 56, 90 and 180
Mean percent change in fissure-wound from baseline (Day 0)
Time frame: Days 0, 14, 21, 28, 42, 56, 90 and 180
Proportion of treated subjects who have ≥ 50% wound closure from baseline (Day 0)
Time frame: Day 14
Proportion of treated subjects who have ≥ 50% wound closure from baseline (Day 0)
Time frame: Day 21
Proportion of treated subjects who have ≥ 50% wound closure from baseline (Day 0)
Time frame: Day 28
Proportion of treated subjects who have ≥ 50% wound closure from baseline (Day 0)
Time frame: Day 42
Proportion of treated subjects who have ≥ 50% wound closure from baseline (Day 0)
Time frame: Day 56
Proportion of treated subjects who have ≥ 50% wound closure from baseline (Day 0)
Time frame: Day 90
Proportion of treated subjects who have ≥ 50% wound closure from baseline (Day 0)
Time frame: Day 180
Time-to-response in days in treated responders
Time frame: Up to 180 days
Time-to symptom improvement in days in treated subjects who achieved symptom improvement
Time frame: Up to 180 days
Time-to 50% wound closure in days in subjects who achieved at least 50% wound closure
Time frame: Up to 180 days
Time-to complete wound closure in days in subjects who achieved complete wound closure
Time frame: Up to 80
Cumulative number of severe adverse events, defined and graded by NCI CTCAE v5.0
Time frame: Up to 180 days
Percent of serious adverse events, including relatedness category
Time frame: Up to 180 days
Percent of treatment-emergent adverse events per system organ class (SOC)
Time frame: Up to 180 days
Proportion of fissure relapse in treated subjects
Time frame: Up to 180 days
Time-to-relapse in days in subjects who experienced relapse
Time frame: Up to 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Anal Fissure
RecruitingObservational study
Ultrasound Assessment After Surgery for Chronic Anal Fissure
Anal Fissure Chronic
Recruiting
AI-Assisted Written Information in Chronic Anal Fissure
Chronic Anal Fissure
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Recruiting
Comparative Outcomes of Inj Botox Alone vs Inj Botox Combined With Fissurectomy and Anoplasty in the Management of Chronic Anal Fissure
Anal Fissure Chronic
Not yet recruitingObservational study
Female Sexual Function After Surgery for Benign Perianal Diseases
Chronic Anal Fissure, Hemorrhoidal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelly Garrett, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E-CEL UVEC cells (AB-207) in people with Chronic Anal Fissure, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Garrett, MD (646-962-2270, keg9034@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of severe injection site reactions (time frame: Up to 180 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.