Cryptoglandular Perianal FistulaPhase 2NCT07557134
E-CEL UVEC Cell Injection Treatment of Perianal Fistulas
A Phase 2 study testing E-CEL UVEC Cells in people with Cryptoglandular Perianal Fistula, run by Angiocrine Bioscience at 1 site in United States.
Trial summary
The purpose of this study is to determine if experimental therapy (E-CEL UVEC Cells), a very minimally invasive procedure, can treat patients with perianal fistulas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cryptoglandular Perianal Fistula
- What is being tested?
- E-CEL UVEC Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- May 2027to Dec 2029
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Willing and able to provide informed consent and medically eligible
- Diagnosed with perianal fistula per the following criteria:
- Diagnosis documented by physical/clinical examination and imaging specifically performed to assess the number and course of the perianal fistula tract---i.e., magnetic resonance imaging (MRI) and/or ultrasound
- Single tract without residual abscess cavity
- Low transsphincteric and intersphincteric fistulas that cross less than 30% of the external sphincter
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- Fistula internal opening width ≤ 3 mm. d. Maximum tract length of 10 cm e. Consistent with cryptoglandular origin f. Fistula-related pain of NRS < 3 (NRS 0-10) g. Absence of history of Crohn's disease, ulcerative colitis or other inflammatory bowel diseases
- For female patients of childbearing potential:
- A negative serum or urine pregnancy test at screening is required prior to enrollment
- Patient must be willing to use a highly effective method of contraception from the start of the screening period until at least 3 months after completion of last treatment
- For male patients who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception:
- Patient must be willing to use a recommended method of contraception and refrain from sperm donation from the start of screening period until for at least 3 months after completion of the last treatment
Who cannot join
- Concomitant rectovaginal fistulas
- Patients with an active abscess or suspicion of an active, untreated microabscess
- Presence of signs and symptoms suggestive or suspicious of an acute active infection or flare-up.
- Fistula-related pain measured as NRS ≥ 3 (NRS Scale 0-10) in the last 7 days.
- If the subject is eligible except for this exclusion criteria of fistula-related pain, then it is recommended that a loose seton be placed to reduce the fistula pain. In this particular situation, once the fistula-related pain is ≤ 2 on NRS (preferably 0 or 1), then the subject may be enrolled and the loose seton removed just prior to the 1st treatment with the investigational product.
- Presence of rectal and/or anal stenosis
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- Presence of setons unless removed prior to the treatment
- Patients with known bleeding disorders.
- Patients with known risk factors for thrombus formation.
- Patients with overlying wound and skin infections.
- Patients with ongoing systemic steroid treatment or treated with steroids within the last 4 weeks prior to treatment
- Renal impairment defined by creatinine clearance below 90 mL/min calculated using Cockcroft-Gault formula or 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.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 2.5 x ULN
- Known history of untreated alcohol or other addictive substance abuse in the 6 months prior to enrollment
- Active malignant tumor (tumors must be in complete remission for ≥ 6 months with completion of maintenance chemotherapy and/or radiation cycles), at least 6 months prior to first treatment
- Current recent history of abnormal, severe, progressive, uncontrolled hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases
- Congenital immunodeficiencies
- Major surgery or severe trauma within the previous 3 months
- Patients who are candidates for solid organ transplantation or who may have a high likelihood of needing a solid organ transplant (e.g., progressive heart failure)
- Female patients who are pregnant or breastfeeding or planning to become pregnant or breastfeed during the treatment regimen with investigational product (Arm A: 0-12 weeks; Arm B (with crossover): 0-24 weeks).
- Patients who have known hypersensitivity or documented allergy to dimethyl sulfoxide (DMSO)
- Patients who do not wish to or cannot comply with study procedures, including completion of all scheduled study visits and treatments
- Patients currently receiving, or having received any investigational drug within 6 months prior to E-CEL UVEC cell therapy
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
New York Presbyterian/Weill Cornell Medical Center
New York, New York, 10028
Jeffrey W Milsom, MD, FACS
About this study
Official title: A Multi-center, Randomized, No Treatment, Concurrent Controlled Study of E-CEL UVEC CELLS for the Treatment of Perianal Fistula
The purpose of this study is to determine if experimental therapy (E-CEL UVEC Cells), a very minimally invasive procedure, can treat patients with perianal fistulas.
- Conditions
- Cryptoglandular Perianal Fistula
- Being tested
- E-CEL UVEC Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-CEL UVEC CellsBiological
Also called Allogeneic genetically engineered human umbilical vein endothelial cells
IP treatment involves percutaneous injections along the entire fistula tract and submucosal injections into the internal tract opening using anoscopic visualization
| Study group | Role | What they receive |
|---|---|---|
| Arm A, Active | Experimental | Not described Receives: Biological: E-CEL UVEC Cells |
| Arm B, No Treatment Concurrent Control, eligible for crossover | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response (CR) rate at Week 12, comparing Arm A to Arm B in parallel.
CR is defined as achieving all the following four criteria:
- Closure of internal opening, plus
- Closure of external tract, plus
- No discharge upon digital pressure, plus
- No clinically meaningful pain
Measured: Week 12
Secondary outcomes (1)
Changes in the anal fistula quality of life (AF-QoL) scale
To assess changes in the quality of life
- Pre-treatment (just prior to 1st treatment) versus 12 weeks after the 1st treatment
- Pre-treatment (just prior to 1st treatment) versus 24 weeks after the 1st treatment
- Pre-treatment (just prior to 1st treatment) versus 36 weeks after the 1st treatment
Measured: Weeks 12, 24, and 36 after first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study startMay 2027 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryptoglandular Perianal FistulaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is designed as an adequate and well-controlled study per 21 CFR 314.126. Specifically, this study utilizes one of the recognized controls: no treatment concurrent control. Primary endpoint consists of objective measurements of effectiveness. Placebo effect for this indication and target population is regarded as negligible. Moreover, a placebo concurrent control is regarded as infeasible for the treatment regimen to treat perianal fistula.
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angiocrine Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557134
- Sponsor's protocol ID
- AB-ECELUVEC-201
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, No Treatment, Concurrent Controlled Study of E-CEL UVEC CELLS for the Treatment of Perianal Fistula
- ClinicalTrials.gov ID
- NCT07557134
- Acronym / sponsor ID
- AB-ECELUVEC-201
- Conditions
- Cryptoglandular Perianal Fistula
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Angiocrine BioscienceIndustry (pharma, biotech, devices)
- Study start
- May 2027 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 29 Apr 2026 (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.
The purpose of this study is to determine if experimental therapy (E-CEL UVEC Cells), a very minimally invasive procedure, can treat patients with perianal fistulas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is designed as an adequate and well-controlled study per 21 CFR 314.126. Specifically, this study utilizes one of the recognized controls: no treatment concurrent control. Primary endpoint consists of objective measurements of effectiveness. Placebo effect for this indication and target population is regarded as negligible. Moreover, a placebo concurrent control is regarded as infeasible for the treatment regimen to treat perianal fistula.
| Arm | Type | Receives |
|---|---|---|
| Arm A, Active | Experimental | Biological: E-CEL UVEC Cells |
| Arm B, No Treatment Concurrent Control, eligible for crossover | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18 or older
- Willing and able to provide informed consent and medically eligible
- Diagnosed with perianal fistula per the following criteria:
- For female patients of childbearing potential:
- For male patients who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception:
Key exclusion criteria (25 listed)
- Concomitant rectovaginal fistulas
- Patients with an active abscess or suspicion of an active, untreated microabscess
- Presence of signs and symptoms suggestive or suspicious of an acute active infection or flare-up.
- Fistula-related pain measured as NRS ≥ 3 (NRS Scale 0-10) in the last 7 days.
- Presence of rectal and/or anal stenosis
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 CellsAlso: Allogeneic genetically engineered human umbilical vein endothelial cellsIP treatment involves percutaneous injections along the entire fistula tract and submucosal injections into the internal tract opening using anoscopic visualization | Biological | Arm A, Active |
Primary outcome
Clinical response (CR) rate at Week 12, comparing Arm A to Arm B in parallel.
Time frame: Week 12
CR is defined as achieving all the following four criteria: 1. Closure of internal opening, plus 2. Closure of external tract, plus 3. No discharge upon digital pressure, plus 4. No clinically meaningful pain
1 secondary outcome
Changes in the anal fistula quality of life (AF-QoL) scale
Time frame: Weeks 12, 24, and 36 after first treatment
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 29 Apr 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing E-CEL UVEC Cells in people with Cryptoglandular Perianal Fistula, run by Angiocrine Bioscience 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 25 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: opening soon, as of the sponsor's last update on 29 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 John R Jaskowiak (877-784-8496, jjaskowiak@angiocrinebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response (CR) rate at Week 12, comparing Arm A to Arm B in parallel. (time frame: Week 12). 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 29 Apr 2026.